MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC

W.L. GORE & ASSOCIATES GORE SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Catalog Number GKFR2025

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Not Applicable (3189); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type Injury

Manufacturer Narrative

(b)(6).Please note: it is not possible to determine from the information provided if the alleged synecor was an intraperitoneal product or a preperitoneal product.Therefore, gore® synecor intraperitoneal biomaterial was indicated as a default selection.The product details will be updated appropriately if additional information is received.(b)(4).It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and states the following: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence." "as with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿.

Event Description

It was reported to gore that a patient alleges to have underwent repair of an abdominal ventral incisional hernia on an unknown date using a gore® synecor biomaterial (type of biomaterial not specified).It was alleged that ¿¿gore¿s synecor mesh fails to perform as intended, require subsequent surgeries for removal and/or rescission [sic], and have caused severe and irreversible injuries, conditions, and damage to the plaintiff.These defects include, but are not limited to: a.Infection; b.Hernia recurrence; c.Bowel obstruction; d.Severe abdominal pain; e.Adhesion; and f.Hospitalization.¿ the complaint states: ¿because of its numerous defects, the synecor mesh creates an unreasonable risk of injury and other adverse health consequences for patients, including, but not necessarily limited to, infection, abscesses, fistula, inflammation, chronic pain, scar tissue, organ perforation, nerve damage and pain that plaintiff endured, and forced the need for intensive medical treatment, including but not limited to additional surgeries to repair/remove the defective mesh and the use of pain control and other medications.¿ it was alleged that ¿the synecor mesh sheet used by plaintiff¿s physician was not substantially changed, modified or altered in any way whatsoever prior to use.The subject synecor mesh sheet reached the plaintiff in such a condition that was unreasonably dangerous to him.The synecor mesh sheet was used in the manner for which it was intended, that is, for abdominal hernia repair.This use resulted in injury to the plaintiff.¿ the complaint states that the ¿¿plaintiff has sustained and will continue to sustain severe and debilitating pain, serious bodily injury and scarring, mental and physical pain and suffering and has incurred economic loss.¿ the complaint further alleges that ¿¿the synecor mesh caused plaintiff to suffer severe and debilitating pain, infections, bleeding, and other severe adverse health consequences.¿ additional, event specific information was not provided.Medical records detailing the above event information have been requested.

Manufacturer Narrative

Initial reporter name and address: corrected initial reporter contact address and phone number.

Manufacturer Narrative

Added date of birth.Added patient weight.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: medical history - coronary artery disease, hypertension, hyperlipidemia, psoriasis, psoriatic arthritis, perforated viscus, ventral incisional hernia, small bowel resection with satisfied reanastomosis weight: 87 kg.Dob: on (b)(6) 1951.Records prior to 2016, including records for the perforated viscus and exploratory laparotomy with bowel resection on (b)(6) 2016, were not provided.Additionally, there are no records detailing the implant.Records dated on (b)(6) 2016, state the patient was seen for a wound check.¿[patient] had dressing fall off surgical site and he states that it drained a lot of fluid and would like it to be looked at.¿ abdominal exam notes state: ¿midline surgical site has small amount of serosanguinous fluid noted on steri-strips.Area cleaned with saline and mastisol, steri-strips and tegaderm dressing reapplied.¿ records dated on (b)(6) 2016, state the patient was seen for follow up status post an exploratory laparotomy with bowel resection on (b)(6) 2016.¿[complains of] with [occasional abdominal] pain & change in bowel habits recently.¿ records dated on (b)(6) 2016, state the patient was seen for follow up.¿[patient] states that he is here today for a follow up after having 1 foot of his small intestine removed 4 months ago.[patient] states that when he lays down his stomach will be flat and normal but when he stands that his stomach will bulge out and have two knots the size of soft balls.¿ the records state: ¿patient has ventral incisional hernia.He currently has ¿staph infection¿ right below being treated with septra ds.Advised to follow up 1 month.¿ ¿ct scan reveals fat containing ventral hernia¿no obstructive features.¿ records dated on (b)(6) 2016, state the patient was seen for a postoperative follow up regarding his incisional hernia.¿assessment: incisional hernia without obstruction or gangrene.¿ ¿provider plan: he is status post i&d [of] small abscess of the abdominal wound.This had an mrsa infection and has been treated with antibiotics as well and has now healed he will proceed with repair of his ventral incisional hernia.¿ records detailing i&d of abdominal abscess were not provided.Operative records dated on (b)(6) 2017, state the patient underwent repair of a ventral incisional hernia with mesh.The records state: ¿the patient a 65-year-old gentleman who previously underwent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.He has now since developed a large ventral incisional hernia.He is now undergoing repair of that ventral incisional hernia with an open technique and placement of mesh.¿ on (b)(6) 2017, operative records state: ¿a skin incision was then made directly overlying the hernia.Subcutaneous tissues were divided until we had identified the hernia sac which was then opened and the abdominal cavity was then entered.There were some adhesions to the hernia sac and these were taken down using both blunt as well as sharp dissection until we had fully exposed the hernia defect.We then prepared the posterior fascia by removing all adhesions, again with both blunt and sharp dissection.We then excised the hernia sac with the bovie cautery in a circumferential fashion, passed this from the table.The anterior fascia was also prepared so that we could achieve a 5 cm overlap in a circumferential fashion for the hernia repair, this required a 20 x 25 cm sheet of synecor as the hernia defect measured approximately 9 to 10 cm x 12 cm.We then placed the synecor in the proper orientation, this was secured in place with interrupted sutures of #1 prolene in a u-stitch fashion achieving a 5 cm overlap of the hernia defect circumferentially.¿ on (b)(6) 2017, operative report continues: ¿once the hernia had been repaired, hemostasis was achieved with the bovie cautery.The wound was copiously irrigated with saline solution until all irrigant was clear.Gentamicin 160 mg was then instilled onto the mycromesh.Two large flat jp drains were then placed through separate stab incisions, one in the right lower quadrant, one in the left lower quadrant placed into the wound and secured in place with single sutures of 2-0 silk.The subcutaneous tissues were closed.It should be noted that the umbilicus was tacked back to the fascia with a single suture of 2-0 vicryl.The 2-0 vicryl was also used to reapproximate the subcutaneous tissues in a running fashion.Skin was closed with staples.¿ it is unclear from the medical records what type of mesh was implanted in the patient.The records first mention that a ¿synecor¿ device was implanted, but a later reference states a ¿mycromesh¿ was implanted.Product identification records for the device implanted on (b)(6) 2017 were not provided.Records dated on (b)(6) 2017, state the patient was seen for fevers with abdominal soreness.The records state the patient ¿had a ventral incisional hernia which developed from previous exploratory laparotomy surgical site.He has had repair of ventral incisional hernia on (b)(6) 2017.The patient had an uneventful postop period and repair of his ventral incisional hernia was doing well, he had his staples and jp drainage removed a few weeks ago without any problems.Patient presented back to the emergency room due to complaints of fever and chills.Stated he had some pain around his periumbilical region as well.Denies any change in his bowel habits.Workup in the emergency room revealed leukocytosis with wbc of 14.3.Ct scan of the abdomen and pelvis without contrast was performed, which revealed moderate amount of fluid density seen superficial to the hernia mesh with a small foci of air, no free air or free fluid was identified, may represent inflammatory infectious process.¿ operative records dated on (b)(6) 2017, indicate the patient underwent ultrasound-guided abdominal wall aspiration for an abdominal wall seroma/abscess.The records state: ¿ultrasound imaging performed to identify entry site.Site was sterilely prepped and draped in usual fashion.1% lidocaine was used for topical anesthesia.Under ultrasound guidance, centesis catheter introduced into the collection with aspiration of 130 ml cloudy yellow fluid.Drain is not accessible at this time for placement.Catheter removed.Sterile dressing applied.¿ ¿impression: successful aspiration of abdominal wall seroma/abscess.We will send samples for culture, sensitivity, and gram stain.¿ a culture report for the specimens collected on (b)(6) 2017 were not provided.Operative records dated on (b)(6) 2017, indicate the patient underwent exploration of an open abdominal wound with wound vac placement.The records state the ¿patient, recently underwent open ventral hernia repair, developed seroma with questionable abscess.Postoperatively he is in today for exploration of the abdominal wound with placement of kci wound vac.¿ ¿findings of fluid collection and open abdominal wound.With no other gross pathological abnormalities appreciated at time of procedure.¿ on (b)(6) 2017, operative notes state: ¿following appropriate anesthesia, 10 blade scalpel then used, and incision was then created between the three small punctate incisions present on the anterior abdominal wall with positive drainage.Incision was deepened down through the skin into the subcutaneous tissue and the incision was then lengthened appropriately to allow direct visualization of the underlying mesh, following this periods, a copious amounts of approximately 1 l of bacitracin saline solution was then used with the surgilav irrigation device and the wound was irrigated.¿ on (b)(6) 2017, operative records continue: ¿prior to irrigation, please note that aerobic and anaerobic cultures were obtained.Following the irrigation, there was good viable tissue noted.No signs or symptoms of infection.At this time, i then placed verso foam in the base of the wound and covered with granular foam.The occlusive dressing was then placed on top of the wound itself, small incision was created in the central portion of the granular foam and the occlusive dressing.The tubing was then attached to the wound vac itself.Wound vac was then placed to 125 mmhg pressure continuous.No leaks were detected.¿ a culture report for the specimens collected on (b)(6) 2017 were not provided.Records dated on (b)(6) 2017, state the patient was seen for a postoperative wound check [status post] exploration of abdominal wound with wound vac placement.Abdominal exam notes state: ¿midline abdominal surgical site has wound vac dressing in place¿dressing removed with pink granulation tissue noted.Wound healing well without signs of infection.Wound vac dressing reapplied with versa foam and then granulofoam.¿ ¿assessment: ventral hernia without obstruction or gangrene.¿ ¿continue wound vac dressing.¿ records dated on (b)(6) /2017, state the patient was seen for post operative follow up on an exploration of the abdominal wound.¿he states the symptoms are acute and have improved.[patient] here for post op follow up after exploration of abdominal wound vac placement done approx.3 weeks ago.Wound vac intact to abdominal wound at present time.¿ ¿provider plan: wound is healing well, in approximation [without] redness or edema.Wound vac removed momentarily to assess situation.Wound vac reinserted.¿ records dated on (b)(6) 2017, indicate past medical/surgical history: ¿elbow orif 9-2017, i/d of elbow¿.Records detailing incision and drainage of elbow were not provided.Records dated on (b)(6) 2017 indicate patient has ¿chronic cough¿.Records dated on (b)(6) 2017, state the patient was seen for a wound.¿the location of the wound is mid abdomen.The patient describes it as dehisced wound.The context consists of dehisced wound, non-healing ulcer and post-surgical.Treatment consists of w/ wound vac.Pertinent negatives include blackened tissue, blistering, bruising, erythema, fenver, infection, numbness and swelling.Comments: patient had mesh placed in abdomen from previous procedure.¿ ¿impression: dehisced wound present at center of abdomen.Wound appears relatively shallow, base is granular.Patient plan: will hold wound vac at this time.However, patient is instructed not to return vac.¿ ¿will consider surgical debridement in the or, pending status of wound at next [follow up].¿ records dated on (b)(6) 2017, state the patient was seen for a wound.¿the patient describes it as non-healing wound.¿ abdominal exam notes state: ¿midline abdominal wound is healing well with beefy red granulation tissue.Wound bed is shallow.Redressed with aquacel and 4x4, tape.¿ records dated on (b)(6) 2017, state the patient was seen for a wound check with a complaint of bloating.Abdominal exam notes state: ¿midline abdominal wound is healing well with small area of granulation.Tissue noted--aquacel dressing in place.5cm x 8mm wound size.¿ records dated on (b)(6) 2017, state the patient was seen for a hernia.¿severity: 5.It occurs occasionally.Location is perumbilical.Additional information: [patient] presents with pain in the area he has [surgery] to repair an incisional hernia back on (b)(6) 2017.[patient] has been coughing a lot and thinks he has had a recurrence.¿ ¿provider plan: dr.(b)(6) believes the mesh is causing the pain.[patient] still needs to avoid lifting over 15-20 lbs and continue wearing the binder.Dr.States the hernia site will continue to bulge to a degree because there¿s still a break in the [fascia].[patient] advised to avoid any activity that can cause an actual recurrence.¿ records dated on (b)(6) 2017, state the patient was seen for ¿infection in the stomach.¿ ¿[patient] presents with a mass on his stomach.The mass is black at the very center and raised.[patient] states he thinks he has staph infection in his intestines.Mass is next to an umbilical/abdominal [surgery] scar.¿ assessment states: ¿cutaneous abscess of abdominal wall.¿ aerobic culture report dated on (b)(6) 2017, states regarding an abdominal wound specimen collected on (b)(6) 2017: ¿heavy growth of methicillin resistant staphylococcus aureus (mrsa).¿ records dated on (b)(6) 2017, state the patient was seen for an abdominal wound check.¿he states the symptoms are acute and have worsened.¿ ¿assessment: cutaneous abscess of abdominal wall.¿ ¿patient plan: patient currently taking augmentin with improvement in abscess.Aerobic culture reveals sensitivity to bactrim and levaquin.Patient reports stomach pain with bactrim.Advised to stop augmentin.Start levaquin¿¿ records dated on (b)(6) 2017 state: ¿h/o mrsa-elbow-and-abdomen-8-9 month¿s ago¿.Records dated on (b)(6) 2017, state the patient was seen for a wound check.¿he states the symptoms are acute and are unchanged.Patient states that he has staff [sic] infection in his abdomen.Patient states that his abdomen swelling.Patient has been on antibiotics.¿ ¿[patient] presents with abdominal edema.[patient states he has staph infection in the i&d wound.[patient] has been taking antibiotics.¿ ¿provider plan: [patient] will have ct scan of abdomen and pelvis.[follow up] 1 week after ct is obtained.Possible hernia.¿ records dated on (b)(6) 2017, state a ct of the abdomen and pelvis were performed.¿no bowel obstruction.No free air or pneurnatosis.Normal appendix.There is a large ventral hernia noted in the region of prior hernia repair.A small focal additional herniation is noted along the inferior and right lateral margin of the prior placed hernia mesh.Anterior abdominal wall musculature is atrophied.Pelvic viscera is without acute finding.No acute bone abnormality.Multilevel degenerative change with disk disease and facet arthropathy.¿ ¿impression: large ventral hernia containing multiple nonobstructed small bowel and colonic segments.Finding is compatible with reherniation.2.No bowel obstruction or free air.¿ records dated on (b)(6) 2017, state the patient was seen for follow up from a ct scan of the abdomen and pelvis.¿[patient] presents [follow up] ct abdomen.[patient] reports continued pain and tremendous pressure associated.¿ past surgical history states: ¿attempted ventral hernia repair ¿ 11-2017.¿ ¿assessment: 1.Ventral hernia.Provider plan: [patient] is not in physical condition to undergo [surgery at the moment].[patient] is to continue on current wound care regimen.¿ there are no records for an ¿attempted ventral hernia repair¿ in november of 2017.Records dated on (b)(6) 2017, state the patient was seen for an abdominal wound check.¿he states the symptoms are acute and have improved.¿ ¿midline abdominal wound is healing without erythema noted.Good granulation tissue noted.4x4 and coversite applied.Ventral hernia noted--reducible.Non-tender.¿ ¿assessment: 1.Ventral hernia.¿ ¿2.Cutaneous abscess of abdominal wall.¿ discharge records dated on (b)(6) 2017, state: ¿patient was seen in the outpatient office¿and found to have a large, ventral, medial abdominal hernia.After exploring possibility of non-operative management, [it was] determined that there would be the most optimal improvement in his condition with surgical operation.¿ ¿[the patient] was admitted to the hospital following surgery for continual monitoring, return of bowel function, appropriate recovery from anesthesia and general surgical observation.¿ ¿there were no acute events in the hospital which were different from the planned course and he was discharged to home with appropriate post-surgical restrictions and general care instructions.¿ the records indicate the patient was admitted to the hospital on (b)(6) 2017.Operative records for the surgical operation performed around on (b)(6) 2017 were not provided.There is no mention of infection and no mention of device removal.Records dated on (b)(6) 2017, indicate a ct was performed for a ¿suspected pulmonary embolism; post ventral hernia repair one week ago.¿ impression from the ct states: ¿there is partially visualized subcutaneous fat stranding in the upper abdominal wall as well as stranding in the preperitoneal fat/greater omentum near the midline.At least one focus of air is seen in the subcutaneous fat in the region of soft tissue stranding.There is a small focus within the stranding abutting the posterior medial left rectus muscle.These probably represent post-surgical changes but are not fully evaluated on this exam.If clinical indicated ct of the abdomen could be obtained for further evaluation.¿ records dated on (b)(6) 2017, states the patient presented for drain removal.¿[patient] reports having hernia repair [surgery].No other complaints, site has little to no drainage.[patient] reports dr.Dumanian used mesh approximately half an inch wide in 2 locations.¿ ¿drain removed from incision site.Site covered with 4x4 gauze.[patient] advised he can remove gauze in 2 days.¿ operative records for the hernia surgery whereby the physician ¿used mesh approximately half an inch wide in 2 locations¿ were not provided.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and states the following: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence." "as with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Updated result code.Conclusion code remains unchanged.

Manufacturer Narrative

H6: updated result code 1 for sterilization evaluation.Conclusion code remains unchanged.H6: added method/result/conclusion codes 2 for manufacturing evaluation.

Manufacturer Narrative

B7: added medical history.D7: added explant date.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records obtained to date and are as follows: unavailable records: for ¿irrigation and debridement small abscess of abdominal wound, mrsa¿ were not provided, but will be requested.Unavailable records: for ¿hiatal hernia¿ were not provided, but will be requested.Unavailable records: for ¿exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis¿ were not provided, but will be requested.(b)(6) 2016: (b)(6).Office notes.Hpi: post op staple removal.Ros: abdominal pain.Exam abdomen: staples removed midline incision.Mastisol, steri-strips, tegaderm dressing applied.Assessment/plan: keep steristrips clean and dry, remove in 7 days.Diverticular diet.F/u 2 weeks.(b)(6) 2016: (b)(6).Office notes.Hpi: wound check.Dressing fall off surgical site, drained a lot of fluid, like it to be looked at.Exam abdomen: midline surgical site serosanguinous fluid on steri-strips.Area cleaned with saline, mastisol, steri-strips, tegaderm dressing reapplied.Assessment/plan: keep surgical sites clean, dry.F/u as scheduled.(b)(6) 2016: pikeville medical center.Grady j.Stephens, md.Office notes.Hpi: follow up colon resection.Ros: abdominal pain, nausea.(b)(6) 2016: pikeville medical center.Grady j.Stephens, md.Office notes.Postop visit.Hpi: post op (b)(6) 2016 s/p exp lap with bowel resection-c/o occ abd pain & changes in bowel habits recently.Ros: gi positive abdominal pain, change in stool pattern.Pain described as 4/10.Unavailable records: for ¿ct abdomen/pelvis with contrast¿ were not provided, but will be requested.(b)(6) 2016: (b)(6).Office notes.Hpi: follow up s/p incisional hernia.Finished levaquin.Ros: skin lesion.Exam abdomen: wound healed, no signs of infection or fluctuance.Assessment: incisional hernia without obstruction or gangrene.Plan: s/p i&d small abcess [sic] abdominal wound.Has mrsa infection, treated w/ antibiotics, now healed, will proceed with repaur [sic] of vental [sic] incisional hernia.(b)(6) 2017: (b)(6).Operative report.Preop dx: a large ventral incisional hernia.Postop dx: a large ventral incisional hernia.Procedure performed: repair of ventral incisional hernia with a 20 x 25 cm sheet of synecor.Anesthesia: general.Complications: none.Specimens: hernia sac, not sent.Drains: two jp drains to the wound with a foley catheter.Indication: ¿the patient a 65-year-old gentleman who previously underwent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.He has now since developed a large ventral incisional hernia.He is now undergoing repair of that ventral incisional hernia with an open technique and placement of mesh.Procedure in detail: patient was taken to the operating room, placed in a supine position, given successful general endotracheal anesthesia.He was then prepped and draped in the usual sterile fashion.A skin incision was then made directly overlying the hernia.Subcutaneous tissues were divided until we had identified the hernia sac which was then opened and the abdominal cavity was then entered.There were some adhesions to the hernia sac and these were taken down using both blunt as well as sharp dissection until we had fully exposed the hernia defect.We then prepared the posterior fascia by removing all adhesions, again with both blunt and sharp dissection.We then excised the hernia sac with the bovie cautery in a circumferential fashion, passed this from the table.The anterior fascia was also prepared so that we could achieve a 5 cm overlap in a circumferential fashion for the hernia repair, this required a 20 x 25 cm sheet of synecor as the hernia defect measured approximately 9 to 10 cm x 12 cm.We then placed the synecor in the proper orientation, this was secured in place with interrupted sutures of #1 prolene in a u-stitch fashion achieving a 5 cm overlap of the hernia defect circumferentially.Once the hernia had been repaired, hemostasis was achieved with the bovie cautery.The wound was copiously irrigated with saline solution until all irrigant was clear.Gentamicin 160 mg was then instilled onto the mycromesh.Two large flat jp drains were then placed through separate stab incisions, one in the right lower quadrant, on in the left lower quadrant placed into the wound and secured in place with single sutures of 2-0 silk.The subcutaneous tissues were closed.It should be noted that the umbilicus was tacked back to the fascia with a single suture of 2-0 vicryl.The 2-0 vicryl was also used to reapproximate the subcutaneous tissues in a running fashion.Skin was closed with staples.Dry sterile dressings were applied.The jp drains were activated.He was then awakened, extubated, and transferred to the recovery room in satisfactory condition.There were no immediate complications.¿ (b)(6) 2017: (b)(6).Implant sticker.Gore® synecor biomaterial.Ref: (b)(4).Sn: (b)(6).(b)(6) 2019.The records confirm a gore® synecor biomaterial (gkfr2025/15010513) was implanted during the procedure.(b)(6) 2017: (b)(6).Discharge summary.Final dx: ventral incisional hernia, s/p repair ventral incisional hernia with synecor mesh.Hpi: previous exploratory laparotomy and small bowel resection for perforated jejunal diverticulitis.Develop bulging previous surgical site, developed large ventral incisional hernia.Hospital course: admitted postoperatively given pca pump for pain.Increase activity level.Positive flatus, bowel movements.Midline surgical site well approximated.Staples, sutures intact.Jp drains x2.Serosanguineous fluid noted.Diet advanced, tolerated, continued feel better, discharged home.Discharge plan: instructed not to drive, strenuous activity or lift more than 10 pounds.Keep surgical sites clean, dry.(b)(6) 2017: (b)(6).Office notes.Hpi: f/u ventral repair.Ros: chills, fatigue, cough, abdominal pain, constipation, back pain.Exam: abdomen; midline staples, jp drains x2 removed.Mastisol, steri-strips, tegaderm dressing applied.No erythema or dehiscence noted.10 ml serosanguinous fluid in jp drains.Plan: keep steri-strips clean, dry, remove in 7 days.Unavailable records: for ¿ct of abdomen/pelvis¿ were not provided, but will be requested.(b)(6) 2017: (b)(6).History and physical.Hpi: had ventral incisional hernia developed from previous exploratory laparotomy surgical site.Uneventful postop period, repair ventral incisional hernia doing well, staples.Presented back to emergency room due to complaints of fever, chills.Pain around periumbilical region.Denies change in bowel habits.Ct scan of abdomen/pelvis w/o contrast, moderate fluid density superficial to hernia mesh, small foci of air, no free air or fluid identified, may represent inflammatory infectious process.Pmh: perforated viscus, ventral incisional hernia.Ros: complains of chills, fever with periumbilical pain.Began chills several days ago.Exam: abdomen soft, slightly tender to palpation right midline surgical scar.No erythema or drainage.Plan: admitted.Iv fluids, npo after midnight.(b)(6) 2017: (b)(6).Operative report.Procedure: ultrasound-guided abdominal wall aspiration.Dx: abdominal wall seroma/abscess.Indication: fluid removal and sampling.Procedure in detail: ¿patient placed supine on table.Ultrasound imaging performed to identify entry site.Site was sterilely prepped and draped in usual fashion.1% lidocaine was used for topical anesthesia.Under ultrasound guidance, centesis catheter introduced into the collection with aspiration of 130 ml cloudy yellow fluid.Drain is not accessible at this time for placement.Catheter removed.Sterile dressing applied.Complications: none.Estimated blood loss: less than 5 ml.Impression: successful aspiration of abdominal wall seroma/abscess.We will send samples for culture, sensitivity, and gram stain.¿ unavailable records: culture report for abdominal wall seroma/abscess was not provided, but will be requested.Unavailable records: for ¿ct abdomen/pelvis¿ were not provided, but will be requested.(b)(6) 2017: (b)(6).Operative report.Pre/postop dx: open wound, abdominal wall.Procedure performed: exploration of abdominal wound with wound vac placement.Specimens: aerobic and anaerobic cultures.Implants: one piece of verso foam, one piece of granular foam with kci wound vac applied.Complications: none.Indications: ¿patient is extremely pleasant 65-year-old male patient, recently underwent open ventral hernia repair, developed seroma with questionable abscess.Postoperatively he is in today for exploration of the abdominal wound with placement of kci wound vac.Procedure in detail: having explained potential risks, benefits, alternatives of procedure, appropriate consent being obtained, patient was taken to the or, placed on the or table in the supine position.He was prepped and draped in usual sterile fashion utilizing betadine solution and sterile drapes.Following appropriate anesthesia, 10 blade scalpel then used, and incision was then created between the three small punctate incisions present on the anterior abdominal wall with positive drainage.Incision was deepened down through the skin into the subcutaneous tissue and the incision was then lengthened appropriately to allow direct visualization of the underlying mesh.Following this periods, a copious amounts of approximately 1 l of bacitracin saline solution was then used with the surgilav irrigation device and the wound was irrigated.Prior to irrigation, please note that aerobic and anaerobic cultures were obtained.Following the irrigation, there was good viable tissue noted.No signs or symptoms of infection.At this time, i then placed verso foam in the base of the wound and covered with granular foam.The occlusive dressing was then placed on top of the wound itself; small incision was created in the central portion of the granular foam and the occlusive dressing.The tubing was then attached to the wound vac itself.Wound vac was then placed to 125 mmhg pressure continuous.No leaks were detected.Patient tolerated the procedure well without complications of above procedure.All sponge and needle counts being correct x2.Patient was transported to recovery, where he was awake and doing well.Findings: findings of fluid collection and open abdominal wound.With no other gross pathological abnormalities appreciated at time of procedure.¿ unavailable records: results for aerobic and anaerobic cultures were not provided, but will be requested.(b)(6) 2017: (b)(6).Discharge summary.Final dx: abdominal wall abscess s/p exploration of abdominal wound with wound vac placement.Hpi: underwent open ventral hernia repair.Developed seroma with questionable abscess.Admitted, started on iv antibiotics.Seen by interventional radiology and abdominal fluid collection aspirated with cloudy fluid obtained.Continued drainage from abdomen.Taken on (b)(6) 2017 to operating room for exploration of abdominal wound with wound vac placement.Transferred to surgical floor.Continued to feel better.Tolerating regular diet.Had flatus and bowel movements.Plan: discharged home.Wound vac dressings monday, wednesday and friday.Not to lift more than 10 pounds.No driving or strenuous activity.(b)(6) 2017: (b)(6).Wound care.Inpatient facility dx: infection following procedure.Change of surgical wound dressing.Other dx: fever, unspecified.Pain in rib and back, chronic.Physician aware of pain.Pain daily, not constantly.Wound location: lower mid abdominal.Length: 7.Width: 3.Depth: 1.Dehiscence of surgical wound.Wound closure: packing, wound vac.Drainage amount: scant.Type: serosanguinous, bloody/frank blood.Undermining wound: tract <2cm.Appearance wound bed: pink/red (granulation).Wound care provided: soiled dressing removed, wound cleansed, drainage system emptied-100ml, wound packed white foam, black foam, dressing applied.No ss [signs or symptoms] infection.(b)(6) 2017: (b)(6).Wound care.Denies pain.Wound location: abdomen.Length: 6.5.Width: 2.Depth: 1.Type: surgical wound.Drainage amount wound: small.Type: serosanguinous.Appearance of wound bed: pink/red (granulation).Clinical note: wound vac intact, running at 125.Removed vac, old dressing.Wound cleaned; white foam placed in wound bed.Picture framed wound, placed small circle black foam, covered with tape.Vac applied.(b)(6) 2017: (b)(6).Wound care.Denies pain.Wound location: abdomen.Length: 6.5.Width: 2.Depth: 0.8.Type wound: surgical.Drainage amount: scant.Type: serous.Appearance wound bed: pink/red (granulation).Clinical note: no pain level noted.Lpn removed wound vac dressing, intact.New dressing and wound vac applied.(b)(6) 2017: (b)(6).Office notes.Hpi: post op.F/u s/p exploration of abdominal wound with wound vac placement.(b)(6) 17: pikeville medical center inc.Wound care.Denies pain.Wound location: abdomen.Wound length: 6.3.Width: 1.6.Depth: 0.5.Type: surgical wound.Wound closure: none.Drainage amount: scant.Type: serous.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: pt sitting on couch, walked to bedroom, laid on bed.Denies any pain.Wound vac intact, running at 125.Wound dressing removed, wound cleaned, new dressing applied, vac reapplied.No ss infection.(b)(6) 2017: (b)(6).Wound care.Location of pain: ribs.Pain chronic.Pain intensity: 6.Wound location: lower mid abdominal.Length: 4.5.Width: 2.Depth: 0.75.Type: dehiscence surgical wound.Closure: wound vac.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: pt walking around livingroom.States ribs still hurting, abdominal wound doesn¿t hurt that bad.Dressing lower mid abdominal dry and intact.No ss of infection.(b)(6) 2017: (b)(6).Wound care.Wound location: abdomen.Wound: length: 4.5.Width: 1.5.Depth: 0.3.Type: dehiscence surgical wound.Closure: vac.Drainage amount wound: scant.Type: serous.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: lpn arrived at home find pt driving up driveway.Lpn asked if he know about homebound status and he states ¿i will go wherever i want to.¿ lpn explained pt needs to be homebound to continue with care, he said ¿well i can just go to the dr and get it done because i don¿t need you people anymore it¿s all about money anyways.¿ lpn asked to do wound vac, he voiced understanding.(b)(6) 2017: (b)(6).Discharge summary.Primary discharge dx: infection following procedure, subsequent encounter.Secondary discharge dx: unspecified infectious disease.Other discharge dx: encounter for change or removal of surgical wound dressing.Fever, unspecified.Discharge instructions: pt discharged after difficulties locating for routine visits and being out driving to other counties during days of planned visits.(b)(6) 2017: (b)(6).Office notes.Hpi: postop f/u exploration of abdominal wound with wound vac placement 3 weeks ago.Wound vac intact to abdominal wound.Exam: wound healing, good granulation, no cellulitis or purulent drainage.Assessment/plan: wound healing w/o redness or edema.F/u with me (b)(6) 2017.(b)(6) 2017: (b)(6).Office notes.Hpi: wound.Onset gradual.Severity mild-moderate.Stable.Location wound mid abdomen.Context consists of dehisced wound, non-healing ulcer and post-surgical.Treatment: wound vac.Negatives include blackened tissue, blistering, bruising, erythema, fever, infection, numbness and swelling.Comments: mesh placed in abdomen previous procedure.Exam: skin, no evidence of infection.Wound: mid abdomen, surgical injury, date acquired 03/08/17, open surgical wound.Wound assessment: width: 1.9.Length: 4.5.Depth: 0.4.Exudate amount/type: moderate, serosanguineous.Wound assessment extended 1: no odor.Margin: distinct, outline attached.Epithelialization: small 1-33%.Wound assessment extended 2: granulation amount: large 67%-100%.Granulation quality: red.Necrosis amount: small 1-33%.Necrosis type: adherent slough.Assessment: dehiscence closure of skin.Impression: dehisced wound present at center of abdomen.Wound appears relatively shallow; base is granular.Plan: hold wound vac.Pt instructed not to return vac.Continue wound care w/ aquacel ag.Perform daily dressing changes.Consider surgical debridement in or, pending status wound next f/u.Follow up wound check 2 weeks.(b)(6) 2017: (b)(6).Office notes.Hpi: wound.Severity mild-moderate.Problem improving.Treatment antibiotics.Ros: skin lesion.Exam: midline abdominal wound healing well, beefy red granulation tissue.Wound bed shallow.Redressed with aquacel and 4x4, tape.Plan: continue aquacel dressings daily.(b)(6) 2017: (b)(6).Office notes.Hpi: postop.Symptoms moderate, occur daily, location abdomen.Ros: bloating, skin lesion.Plan: continue aquacel dressing changes daily.(b)(6) 2017: (b)(6).Office notes.Hpi: hernia.Severity: 5.Occurs occasionally.Location periumbilical.Presents with pain in area repair incisional hernia (b)(6) 2017.Been coughing a lot, thinks had recurrence.Reports gas, bloating when eats.Assessment: abdominal pain, bloating.Plan: dr.Stephens believes the mesh is causing pain.Avoid lifting over 15-20 lbs., wear binder.Dr.States hernia site continue to bulge because still a break in fasca [sic].Avoid activity that cause recurrence.F/u 3 months.Take gas-x when gas and bloating occur.(b)(6) 2017: (b)(6).Office notes.Hpi: hernia.Duration: 1 month.Severity: 5.Occurs occasionally.Location: periumbilical.Pt states he thinks he has another hernia.Ros: abdominal pain.(b)(6) 2017: (b)(6).Office notes.Hpi: infection in stomach, 2 weeks.Symptoms mild, occur randomly.Presents with mass on stomach.Mass is black at center and raised.Pt thinks he has staph infection in intestines.Mass next to umbilical/abdominal scar.Assessment: cutaneous abscess of abdominal wall.(b)(6) 2017: (b)(6).Office notes.Hpi: infection in stomach.Symptoms began 2 weeks ago.Symptoms mild, occur randomly, abdomen.Symptoms acute and unchanged.Pt states he thinks he has ¿staff¿ infection in his intestines.Pmh: mrsa of elbow and abdomen 8-9 months ago.Ros: cough, abdominal pain.(b)(6) 2017: [facility not identified].(b)(6).Microbiology ¿ aerobic culture.Source: wound abdomen.Heavy growth of methicillin resistant staphylococcus aureus (mrsa).(b)(6) 2017: (b)(6).Office notes.Hpi: wound check.Symptoms began 1 weeks ago, lasts 1 week.Symptoms mild, occur randomly.Symptoms acute and worsened.Assessment/plan: cutaneous abscess of abdominal wall.Currently taking augmentin with improvement in abscess.Aerobic culture reveals sensitivity to bactrim and levaquin.Stomach pain with bactrim.Stop augmentin.Start levaquin for 14 days.Continue daily saline wet to dry dressing changes.(b)(6) 2017: (b)(6).Office notes.Hpi: wound check.Abdominal edema.Pt states he has staph infection in the i&d wound.Taking antibiotics.Ros: abdominal pain.Plan: ct scan abdomen/pelvis.Possible hernia.(b)(6) 2017: [facility not identified].(b)(6).Radiology-ct abdomen/pelvis with and without contrast.Findings: large ventral hernia region of prior hernia repair.Small focal additional herniation along inferior and right lateral margin of prior placed hernia mesh.Anterior abdominal wall musculature atrophied.Impression: large ventral hernia containing multiple nonobstructed small bowel and colonic segments.Findings compatible with reherniation.(b)(6) 2017: (b)(6).Office notes.Hpi: hernia.F/u from ct scan of abdomen/pelvis.Continued pain, pressure.Ros: abdominal pain.Assessment: ventral hernia.Plan: not in physical condition to undergo s/x atm.Continue current wound care.Continue wearing binder, avoid strenuous activity, lifting over 10 lbs.Avoid trauma to chest, abdomen.(b)(6) 2017: (b)(6).Office notes.Hpi: wound check.Exam: midline abdominal wound healing without erythema.Good granulation tissue.4x4 and coversite applied.Ventral hernia noted-reducible, non-tender.Assessment: ventral hernia, cutaneous abscess of abdominal wall.Plan: continue abdominal binder.Avoid strenuous activities.F/u 2 weeks.Continue aquacel dressings to abdomen daily.Unavailable records: for ¿nm plastic & reconstructive surgery office visit with gregory a.Dumanian, md.Dx: hernia¿ were not provided, but will be requested.(b)(6) 2017: (b)(6).Operative report.Pre/postop dx: massive midline ventral hernia after diverticulitis procedure and prior attempt at hernia repair with mesh.Procedures: removal of previously placed hernia mesh.Repair of midline ventral hernia with bilateral sliding myofascial rectus abdominis flaps and use of retrorectus soft prolene mesh.Vertical abdominoplasty.Indications: ¿this 66-year-old gentleman has the above diagnoses.He had a hernia after diverticulitis surgery, and had 1 attempt at a mesh closure.The patient understood the risks and benefits, risks including, but not limited to bleeding, infection, need for further procedures.He understood these issues and gave informed consent to proceed.Procedure note: the patient was prepped and draped in the usual manner.Previous midline incision was opened after carefully marking his midline structures, and we got into the abdomen without difficulty.The incision was made from the xiphoid all the way to the symphysis pubis.After completely freeing the midline incision, we divided the old mesh in half, and his hernia was approximately 12 cm in transverse dimension by ct scan.Carefully, the mesh was dissected free from surrounding tissues and the prolenes that were holding it in place.It seemed to be a polyester type mesh.There were no bowel in uries.After excising the mesh and the posterior aspect of the abdominal wall, skin flaps were elevated for [illegible] cm off of the anterior rectus fascia for the length of the closure.There was no way to bring the muscles and soft tissues to the midline.Therefore, bilateral sliding myofascial rectus abdominis flaps were created.On the right side, through a 6 cm transverse incision, dissection down to the right semilunar line was performed.The right external oblique muscle and fascia was divided from farther above the rib cage down to the level past the anterior superior iliac spine through this transverse incision.The deep fascia of the external oblique was divided, and external oblique was mobilized off of the internal oblique.Identical procedure was performed on the left-hand side to create a left-sided myofascial rectus abdominis flap.Dissection through the 6 cm incision was made, and tissue was elevated off the semilunar lines.The left external oblique muscle and fascia was then divided to create a left-sided myofascial rectus abdominis flap.At this point, we got into the retrorectus space, though there was a scarring from the prior mesh placement, we were able to get to reasonable posterior fascia.However, superiorly, it will be difficult to get the posterior fascia completely closed.Therefore, in an inferior to superior direction, the closure was then performed.We closed a bit of the posterior fascia, and then used both mesh strips for the anterior rectus fascia, and retrorectus mesh 7.5 cm wide, with bites [illegible] cm from the medical border of the rectus muscle to help bring the rectus muscles together.Brining the anterior muscles together, brought the posterior fascia toward the midline along with it.Therefore, we essentially [illegible] up the fascia from inferior to superior, closing some posterior fascia, then closing the muscle, and then closing anterior fascia, and doing these maneuvers in this way, we got the posterior fascia completely closed.Then, the final mesh sutures were used to bring the medial border of the rectus muscles to the midline.Two drains were placed in the midline, and 1 in each of the release sites.The skin then had its abdominoplasty.After carefully undermining, we were able to excise a good amount of skin in a vertical pattern.We used pumpkin-teeth flaps to create a neoumbilicus.The skin was then closed after hemostasis achieved with 3-0 vicryl suture and a [illegible] -0 monocryl suture.That was the vertical abdominoplasty.At the end of procedure, sponge and needle counts correct.I was present the entire procedure.¿ unavailable records: for a pathology report detailing analysis of device removed during the (b)(6) 2017 procedure was not provided, but will be requested.(b)(6) 2017: northwestern memorial hospital.Gregory dumanian, md.Discharge summaries.Discharge dx: ventral hernia without obstruction or gangrene.Hospital course: admitted following surgery, return bowel function, recovery from anesthesia, general surgical observation.No acute events, discharged home.F/u in office.Exam: abdomen soft, non-distended, non-tender, incisions clean, dry, intact, minimal tenderness.Drains: serosanguinous output.Skin: wounds clean, non-inflamed.Refrain heavy lifting more than 10 pounds or strenuous activity.Unavailable records: for ¿nm plastic & reconstructive surgery office visit with gregory a.Dumanian, md for dx: aftercare following surgery¿ were not provided, but will be requested.(b)(6) 2017: nmh radiology.(b)(6).Radiology-ct pe chest angiography.Hx: suspected pulmonary embolism; post ventral hernia repair.Impression: no pulmonary embolism.Visualized subcutaneous fat stranding in upper abdominal wall, stranding in preperitoneal fat/greater omentum near midline.One focus of air seen in subcutaneous fat in region of soft tissue stranding.Small focus of air associated with skin defect more superiorly in midline anterior abdominal wall.Small high-density focus within stranding abutting posterior medial left rectus muscle.Probably represent post-surgical changes but not fully evaluated on exam.Unavailable records: for ¿nm plastic & reconstructive surgery, office visit with dx: aftercare following surgery for injury or trauma¿ were not provided, but will be requested.(b)(6) 2017: (b)(6).Office notes.Hpi: f/u for drain removal.Reports having hernia repair.No complaints, site has little to no drainage.Reports dr.Dumanian used mesh approximately half and inch wide in 2 locations.Ros: abdominal pain.Plan: drain removed.Site covered 4x4 gauze.Remove gauze in 2 days.F/u prn.Unavailable records: for ¿attempted ventral hernia repair¿ were not provided, but will be requested.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and states the following: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence." "as with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: unavailable records: for ¿ct abdomen with contrast' 2005, 2007 and for ¿ct abdomen without contrast¿ 2011, were not provided.Unavailable records: for ¿hiatal hernia¿ were not provided.Unavailable records: for ¿op visit at (b)(6) center between 09/24/15 through 10/12/15¿ were not provided.Records between 7/22/05 and 4/26/16 were not provided.Unavailable records: for ¿exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis¿ were not provided.Unavailable records: for ¿ct abdomen/pelvis w/o contrast¿ 2016, were not provided.Unavailable records: for ¿er visit¿ were not provided.Unavailable records: for ¿ct abdomen & pelvis w contrast¿ were not provided.Unavailable records: for ¿operative procedure at (b)(6) center¿ were not provided.Unavailable records: for ¿ct abdomen/pelvis w contrast¿ were not provided.Unavailable records: for ¿er visit¿ were not provided.Unavailable records: for ¿operative procedure¿ were not provided.On (b)(6) 2017: nmff plastic/reconstructive surgery.(b)(6), md, facs.Office notes.Diagnosis: ventral hernia without obstruction or gangrene.Consultation hernia repair.Disk from outside hospital demonstrating large ventral hernia containing multiple nonobstructive small bowel and colonic segments.Defect measures 8-10 cm across.Exam: large ventral hernia containing loops of bowel, partially compressible.Midline scar healed, no open wounds.Plan: ventral hernia repair using sheet of mesh, release of lateral abdominal wall with component separation, mesh strip repair of anterior rectus sheath and muscle.Bactroban ointment to bilateral nares for 7 days prior to surgery, history of multiple staph infections and likelihood he is chronically colonized with staph.On (b)(6) 2017: (b)(6) hospital.(b)(6), md.Addendum for history and physical.No changes in patient condition.Pre-op surgical diagnosis: abdominal hernia.Exam: abdomen-well healed midline scar, tender to palpation at inferior aspect, midline hernia.Plan: to or for components release, hernia repair, abdominoplasty.On (b)(6) 2017: (b)(6) hospital.Implant record.Mesh hern sft prol 14 x 12in polypr flt.Site: abdomen.On (b)(6) 2017: (b)(6) hospital.(b)(6), md.Pathology report.Final diagnosis: ventral hernia, repair: dense fibroconnective tissue with acute and chronic inflammation, granulation tissue.History: abdominal hernia.Specimen/gross description: received fresh, labeled with patient¿s name and designated on requisition as ¿old mesh,¿ area multiple fragments of pink-tan mesh material containing numerous sutures with adherent soft yellow-tan tissue and pink-tan fibroconnective tissue.Within the tissue, there is a 2.4 x 1.5 x 1.5cm rubbery pink-tan nodule.The nodule is sectioned to reveal rubbery white cut surfaces with a softened tan center.The remaining tissue is unremarkable.Representative sections are submitted as follows: nodule, representative soft tissue.On (b)(6) 2017: (b)(6) hospital.(b)(6), md.Progress notes.No events overnight, wound causing minimal complaints, no concerns.Exam: abdomen soft, non-distended, non-tender.Skin: wounds clean, without excessive erythema, non-inflamed, incisions are clean, dry, intact minimal tenderness, without erythema or swelling.On (b)(6) 2017: (b)(6) hospital.(b)(6) , md.Progress notes.Had flatus, bowel movement, walked a lot.Exam: abdominal incision with steri strips c/d/i [clean/dry/intact], abdominal binder.Drains serosanguinous output, non-concerning amount.Doing well.On (b)(6) 2017: nmff plastic/reconstructive surgery.(b)(6), md, facs.Office notes.Large hernia repair treated with mesh suture technique.Two of 4 drains removed today.Good bowel movements, pain acceptable.Issue with shortness of breath.Baseline asthma.Go to emergency room.On (b)(6) 2017: [facility not identified].Nurses notes.Seen for follow up appt with dr.Dumanian.Reports feeling better.Incision cdi [clean, dry, intact], no s/s infection.One drain removed.One drain remaining.Pt advised if develops new pain, n/v, go to ed, these are s/s of bowel obstruction.Continue monitoring drainage from jp.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and states the following: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence." "as with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2097: (b)(6), md.Radiology: barium swallow.Impression: small hiatal hernia.On (b)(6) 2007: (b)(6), md.Radiology: ct abdomen/pelvis.Indication: abdominal pain.Comparison: on (b)(6) 2005.Impression: abdominal organs within normal limits.Right suprarenal mass 2.1 x 2.0 cm; consistent as simple cyst.On (b)(6) 2009: (b)(6), md.Procedure report.Esophagogastroduodenoscopy.Indication: epigastric pain.Impression: superficial gastritis, diffuse.Duodenitis.Gastric polyp.On (b)(6) 2011: (b)(6), md.Radiology: ct abdomen.Impression: hepatic and right renal cysts.No evidence of intra-abdominal abnormality.1on (b)(6) 2014: (b)(6), md.Office notes.Impression/plan: recurrent polyarticular inflammatory arthritis, dactylitis suggestive of psoriatic arthritis.Start prednisone [steroid], consider increasing methotrexate [immunosuppressant].On (b)(6) 2015: (b)(6), md.Office notes.Hemorrhoids.Context: heavy labor, heavy lifting, prolonged sitting.On (b)(6) 2015: (b)(6), md.Office notes.Increasing pain.Plan: discontinue methotrexate, try arava [immunosuppressant].On (b)(6) 2016: (b)(6), md.Office notes.Chronic upper and lower abdominal pain, rectal bleeding.Impression/plan: gastroesophageal reflux disease.Schedule esophagogastroduodenoscopy, colonoscopy.On (b)(6) 2016: (b)(6), md.Office notes.Joint pain.Impression/plan: did not tolerate methotrexate; took arava last 4 months with no help.Add enbrel, ibuprofen as needed.On (b)(6) 2016: (b)(6), md.Radiology: ct abdomen/pelvis.Indication: abdominal pain.Impression: acute perforation of a 2.4 cm proximal jejunum diverticulum.Debris and gas leaking from the diverticulum remain close in proximity.Mild associated ileus or partial obstruction, inflammatory stranding in the mesentery subtending this segment of proximal small bowel.Trace fluid in the cul-de-sac but no free fluid elsewhere in peritoneal cavity.No free intraperitoneal air.Bilateral renal cysts; nonspecific perinephric stranding both sides.Mild obstipation.On (b)(6) 2016: (b)(6), md.Radiology: us abdomen.Indication: abdominal pain.Impression: small amount of gallbladder sludge, no gallstones.Few right renal cysts.No upper abdominal fluid collections or ascites.On (b)(6) 2016: (b)(6), md.Radiology: ct abdomen/pelvis.Indication: abdominal pain.Impression: appears to be a perforation of proximal small bowel in the mid abdomen.These are seen as air and small amount of fluid or edema in the mesentery adjacent to slightly dilated small bowel loop.On (b)(6) 2016: (b)(6), md.History & physical.Presented through emergency room with acute onset of abdominal pain, upper epigastric region.Abdomen: soft, tender to palpation in upper quadrants.Guarding and rebound tenderness present.Ct scan reveals what appears to be perforation of proximal small bowel in mid abdomen.Air and small amount of fluid or edema in the mesentery adjacent to slightly dilated small bowel loops.Impression: perforated viscus confirmed by ct scan and physical exam consistent with acute abdomen with complaints of upper quadrant abdominal pain.Plan: taken emergently for exploratory laparotomy, possible bowel resection.On (b)(6) 2016: (b)(6), md.Operative report.Preoperative diagnosis: perforated viscus.Postoperative diagnosis: perforated viscus being the proximal jejunum from diverticula.Procedure: exploratory laparotomy with small bowel resection, with side-to-side anastomosis between the distal and proximal jejunum.Anesthesia: general.Complications: none.Specimens: anaerobic and aerobic cultures as well as segment of jejunum.Estimated blood loss: 50 cc.Drains: nasogastric tube and foley catheter.Indication: the patient is a 65-year-old gentleman in usual state of health, until severe acute onset of abdominal pain early today, progressively worsened.It started in the upper quadrants, radiated up into the chest, became diffuse.Physical exam in the emergency room revealed diffuse involuntary guarding with rebound.Ct scan revealed some dilated loops of small-bowel proximal jejunum with diverticula, with loculated free air and fluid between the loops of the proximal jejunum, consistent with a perforated viscus.Physical exam and ct scan are consistent.He is now undergoing exploratory laparotomy with possible bowel resection, possible colostomy, and any necessary procedure.Procedure in detail: ¿patient taken to the operating room, placed in supine position, given successful general endotracheal anesthesia, prepped and draped in the usual sterile fashion.Midline abdominal incision was then made, and the abdominal cavity was then entered under direct vision.Immediately, some purulent fluid was obtained, and this was cultured both anaerobically and aerobically.This emanated from the area of the left upper quadrant, in the area of the ligament of treitz and the proximal jejunum.Multiple diverticula were noted in the approximately one-foot segment of proximal jejunum.It was unclear which [sic] was the diverticula perforated.I believe it probably had a small panel of perforation and then sealed itself, as we were unable to express any succus from the small bowel.In any event, exploration was carried out.The duodenum was normal as well as proximal, as well as the anterior and posterior walls of the stomach.Small bowel was ran from the ligament of treitz down to the ileocecal valve.No other abnormalities were present.Colon was palpated without abnormality.It was noted to have severe left-sided diverticular disease, but no evidence of colonic perforation.Bilateral kidneys normal to palpation as well as the pancreas, liver, spleen, and gallbladder.We then performed a resection of the small bowel by dividing the proximal jejunum with a gia stapling device.The more distal portion of the jejunum passed through the large diverticula, also with a gia stapling device.Mesentery was taken down with the enseal super jaw.Specimen was passed from the table, and sent for permanent pathology.Side-to-side anastomosis was performed between the proximal and mid jejunum.This was done with a stapled technique.3-0 silk sutures were used to buttress the angles of sorrow and the anterior staple line.Mesenteric defect was closed with a running interlocking suture of 3-0 chromic.Palpation of the anastomosis revealed this to be patent.The abdominal cavity was then copiously irrigated with bacitracin solution until all solution was clear.We then returned everything to its normal position.The midline abdominal incision was closed by reapproximating the fascia with a #1 looped pds, and skin was closed with staples.Dry sterile dressings were applied.Patient tolerated the procedure well.There were no immediate complications.All sponge, needle, and instrument counts were correct x2.He was awakened, extubated, and transferred to the recovery room in satisfactory condition.¿ on (b)(6) 2016: (b)(6) center.Microbiology.Source: abdomen.Ruptured jejunum.1.Anaerobic culture: on (b)(6) 2016: no growth on primary plates; broth culture negative at 48 hours, final report to follow.On (b)(6) 2016: no anaerobes isolated.On (b)(6) 2016: (b)(6), md.Discharge summary.Final diagnosis: perforated viscus status post exploratory laparotomy, small bowel resection with side-to-side anastomosis between the distal and proximal jejunum.Presented to emergency room with acute onset of approximately 2 ½ hours of upper quadrant abdominal pain.Taken for emergent exploratory laparotomy, noted to have perforated viscus.Hospital course: given pump for pain, kept nothing by mouth.Began to increase activity level, have gastrointestinal function.Midline abdominal incision remained well approximated with staples and sutures intact.Nasogastric tube discontinued, diet advanced; tolerated without difficulty, ambulating without difficulty.Denied increased nausea, vomiting or abdominal pain.Discharged home.Discharge plan: resume home medications, soft diet.Instructed not to drive, do any strenuous activity or lift more than 10 pounds.Keep surgical site clean, dry.Follow up dr.Stephens 1 week.On (b)(6): [facility ni].Discharge medication summary.Leflunomide [immunosuppressant], methylprednisolone [steroid].On (b)(6) 2016: (b)(6), md.Office notes.Status post colon resection.Complains of bloody drainage; here for stitches removal.Positive abdominal pain.Impression/plan: surgical site healing well.Every other staple removed.Incision healing in approximation without redness, edema, bruising or drainage.Follow up 1 week.On (b)(6) 2016: (b)(6), do.Emergency department visit.Evaluation of post-surgical open incision; last set of stitches removed 4 days ago.Notes skin beginning to reopen; opening larger with time, notes leaking clear fluid and a little blood.Currently taking amoxicillin.Abdomen: 4 cm open area incision below umbilicus; no bleeding, drainage or erythema.Impression: disruption wound, unspecified.Plan: mastisol liquid adhesive over surgical incision with 4 steri-strips applied horizontally.Discharged in stable condition.On (b)(6) 2016: (b)(6) center.Microbiology report.Source: wound not spec.1.Aerobic culture: on (b)(6) 2016: rare growth of usual skin flora.On (b)(6) 2016: impression/plan: no hernia noted during exam, surgical sites healing well.Return to normal activity.On (b)(6) 2016: (b)(6), md.Office notes.Complains of pain and rash.Had small intestine perforation 2 months ago; doing well.Restart arava.On (b)(6) 2016: (b)(6), md.Emergency department visit.Sent for ct scan by dr.(b)(6) office.Had surgery 3 months ago.States when he eats stomach swells up then goes back down.Abdomen: soft, very mild tenderness, palpation reproduces pain.Impression: pain postprocedural, acute.Cellulitis abdominal wall.On (b)(6) 2016: [facility ni].[provider ni].Radiology: ct abdomen/pelvis.Comparison: on (b)(6) 2016.Impression: status post bowel resection and anastomosis.Adjacent to the anastomotic bowel in left upper quadrant, is an indeterminate 1.8 cm area of standing and fluid.Could reflect omental infarction or sequela of post-surgical change.Could reflect inflammatory process of the mesentery or small bowel in this area near anastomosis.No evidence of bowel obstruction.Fat stranding and inflammatory changes along midline in subcutaneous soft tissue along umbilicus superiorly.Could reflect superficial cellulitis.On (b)(6) 2016: (b)(6), md.Office notes.Abnormal ct scan.Complains of constant abdominal pain; worsens with eating, abdominal distention.Impression/plan: examination: incisional hernia was felt; follow up ct abdomen/pelvis.On (b)(6) 2016: (b)(6), md.Radiology: ct abdomen/pelvis.Indication: incisional hernia.Comparison: on (b)(6) 2016.Impression: fat-containing ventral hernia along the midline with diastasis recti.Diverticulosis without acute diverticulitis.On (b)(6) 2016: (b)(6), aprn.Office notes.States follow up after having 1 foot of small intestine removed 4 months ago.States when lays down his stomach will be flat and normal but when stands, stomach will bulge out and have two knots the size of soft balls.Positive bloating.Abdomen: ventral incisional hernia noted when coughing, diastasis recti noted, soft, reducible.Impression/plan: ventral incisional hernia.Currently has ¿staph infection¿ right elbow being treated with septra ds.Advised follow up 1 month.Ct scan reveals fat containing hernia, no obstructive features.On (b)(6) 2016: (b)(6) center.Microbiology.Source: abscess right elbow.1.Aerobic culture: on (b)(6) 2016: light growth of methicillin resistant staphylococcus aureus (mrsa).On (b)(6) 2016: (b)(6) center.Microbiology.Source: abscess right elbow.1.Aerobic culture: on (b)(6) 2016: heavy growth of methicillin resistant staphylococcus aureus (mrsa).On (b)(6) 2016: (b)(6), md.Office notes.Presents for ventral hernia; chronic.No pain.Complains of uncomfortable feeling and increase in size.Wears abdominal binder daily when active.Impression/plan: ventral incisional hernia.Seeing nadar for elbow; follow up in 5-6 weeks after cleared from nadar.On (b)(6) 2016: (b)(6), md.Office notes.Stopped arava and had right elbow surgery after possible tendon injury complicated with mrsa.Impression/plan: did not take medicine for 1 month and does not complain of pain or psoriasis; would like to stay off arava for now.On (b)(6) 2016: (b)(6), md.Office notes.Complains of pain, does wear binder.Impression/plan: ventral incisional hernia.Will schedule for repair.On (b)(6) 2016: (b)(6).Anesthesia record.Diagnosis: ventral incisional hernia.Procedure: ventral incisional hernia repair with mesh.Asa: 3.Weight 205.9 lbs., bmi 28.7.On (b)(6) 2016: (b)(6), md.Operative report.Preoperative diagnosis: ventral incisional hernia.Postoperative diagnosis: abdominal wall abscess.Ventral incisional hernia.Procedure: incision and drainage of abdominal wall abscess.Anesthesia: general.Complications: none.Specimens: anaerobic and aerobic cultures.Estimated blood loss: none.Indication: the patient is a 65-year-old gentleman, previously underwent a small bowel resection secondary to a perforated jejunal diverticulum.He has subsequently developed a ventral incisional hernia.He is now undergoing repair.Procedure in detail: ¿patient was taken to the operating room, placed in supine position, given successful general endotracheal anesthesia, was prepped and draped in the usual sterile fashion.On examination of the abdominal wall, it appeared that the patient had a pocket of an abscess in the midline incision.This was then opened and indeed we did obtain purulence.This was then cultured both anaerobically and aerobically.This was then fully opened and finger fractured and completely evacuated and packed with a betadine-soaked gauze and covered with dry sterile 4x4s and tape.This effectively terminated the planned procedure of repair of ventral incisional hernia as the patient will be at very high risk for placement of mesh with the risk of infection of the mesh should we proceed at this time; therefore the procedure was terminated.This was discussed with the patient¿s son, who was in complete understanding.We will allow the wound to heal and he will be rescheduled at a later date for repair of his ventral incisional hernia.¿ on (b)(6) 2016: (b)(6) center.Microbiology.Source: wound ventral incisional hernia.1.Anaerobic culture: on (b)(6) 2016: no anaerobes isolated.1.Aerobic culture: on (b)(6) 2016: rare growth of methicillin resistant staphylococcus aureus (mrsa).On (b)(6) 2016: (b)(6), aprn.Office notes.Hernia.Context: physical activity.Risk factors: previous abdominal surgery.States currently on antibiotics.Was scheduled for hernia repair last week but was canceled due to infection.Positive abdominal pain.Abdomen: 2 cm open wound along previous midline surgical scar; beefy, red granulation tissue.Impression/plan: incisional hernia.Continue leaquin [sic], saline wet to dry dressing changes.Follow up 2 weeks.Aerobic culture reveals mrsa abdominal wound; prescribed levaquin.On (b)(6) 2016: [facility ni].(b)(6), md.Office notes.Telephone message: has questions about upcoming surgery.States he would rather have stitches than mesh; he doesn¿t think the mesh is right for him.Spoke with patient about concerns.Patient to call back on (b)(6) 2017 to speak with dr.(b)(6).On (b)(6) 2017: (b)(6).Anesthesia summary.Asa: 3.Weight: 212.3 lbs.On (b)(6) 2017: (b)(6), do.Pathology report.17-se-484.Diagnosis: ventral hernia, excision: fibroadipose tissue with focal fat necrosis and skeletal muscle.Negative for malignancy.Tissue submitted: hernia, ventral, surgical excision sac.Clinical information: ventral hernia.Gross description: one specimen is received in formalin labeled ¿hernia sac¿ and consists of multiple fragments of pink-yellow fibro adipose tissue measuring 11 x 8 x 2.4 cm.The specimen is submitted entirely in cassette a.Microscopic description: microscopic examination was performed.On (b)(6) 2017: (b)(6), md.Radiology: ct abdomen/pelvis.Comparison on (b)(6) 2016.Impression: status post interval anterior abdominal wall hernia repair with moderated fluid density superficial to the hernia mesh with small foci of air.This may represent an inflammatory or infectious process.On (b)(6) 2017: (b)(6) center.Lab.Albumin 3.0, low.(3.4-5.0).On (b)(6) 2017: (b)(6).Progress notes.Impression/plan: ventral abscess; likely radiology guided drainage.Psoriasis arthritis; not on medication.Sepsis.Hyperglycemia; check hemoglobin a1c.On (b)(6) 2017: (b)(6) center.Microbiology.Source: fluid abdominal abscess.1.Fluid culture: on (b)(6) 2017: heavy growth of a possible hemolytic staphylococcus with light growth of a lactose fermenting gram negative rod to be further studied.On (b)(6) 2017: heavy growth of methicillin resistant staphylococcus aureus (mrsa) with light growth of klebsiella oxytoca.On (b)(6) 2017: (b)(6), md.Radiology: ct abdomen/pelvis.Impression: there continues to be fluid in the subcutaneous tissues anterior to the mesh.There continues to be some bubbles of gas present within the fluid suggesting that it may be infected.On (b)(6) 2017: (b)(6) center.Microbiology.Source: aerobic misc abdominal wound.Abdominal wound (contam).1.Anaerobic culture: on (b)(6) 2017: no growth on primary plates; broth culture negative at 48 hours, final report to follow.On (b)(6) 2017: no anaerobes isolated.On (b)(6) 2017: (b)(6) center.Lab report.Albumin 2.6, low.(3.4-5.0).On (b)(6) 2017: (b)(6).Physician orders.Wound care: wound vac changes monday, wednesday, friday.Conditions: fever, abdominal pain.Has wound vac and high risk of infection at this time.On (b)(6) 2017: (b)(6), aprn.Office notes.Status post exploration of abdominal wound with wound vac placement.Abdomen: midline abdominal surgical site has wound vac dressing; removed with pink granulation tissue noted.Wound healing without signs of infection.Wound vac dressing reapplied.Continue vac dressing, follow up 2 weeks.On (b)(6) 2017: midline abdominal wound healing well with small area of granulation tissue; 5 cm x 8 cm wound size.On (b)(6) 2017: abdomen: incision and drainage site right abdomen has small amount of drainage on dressing; beefy red granulation tissue noted, decreased erythema.On (b)(6) 2017: (b)(6), do.Emergency department visit.Complains of assault.Hit in abdomen as well.Significant history of abdominal surgeries; another surgery in two weeks.States increased amount of swelling form abdomen after being hit.Abdomen: firm, mild tenderness; diffuse, erythema noted.Wearing abdominal binder; wears full time.Discharged home.On (b)(6) 2017: (b)(6), md.Radiology: ct abdomen/pelvis.Impression: no gastrointestinal or genitourinary obstruction.Colonic diverticulosis with no evidence of acute diverticulitis.Redemonstration of prior postoperative changes of ventral hernia repair with mesh with large ventral hernia containing non-dilated loops of small and large bowel.On (b)(6) 2017: (b)(6), aprn.Office notes.Cough x 2 months; hacking cough.History of asthma that is well controlled.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® synecor intraperitoneal biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Previous patient codes (3190) were reported based on the original complaint and are no longer applicable per gore¿s investigation.H10/11: updated final codes.H10/11: additional conclusion code: 4316: appropriate term/code not available used for "withdrawn complaint" this claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed.

Manufacturer Narrative

H6: updated patient codes.H6: updated device codes.H6: updated conclusion codes.H6: 4316: appropriate term/code not available for ¿withdrawn complaint¿.This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Previous patient code (3190) was reported based on the original complaint and is no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: ¿ the known medical records span july 1, 1997 through november 11, 2018 and not all records received in this time span are relevant to the gore® synecor biomaterial.Patient information: medical history: hypertension.Hyperlipidemia.Hiatal hernia.Gastroesophageal reflux disease.Gastritis.Duodenitis.Chronic abdominal pain.Perforated proximal jejunum diverticulum.Wound disruption.Ventral hernia.Diastasis recti.Methicillin resistant staphylococcus aureus [mrsa] infection of abdominal wound.Perforated viscus.Prior surgical procedures: (b)(6) 2016: emergent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.(b)(6) 2016: i&d of abdominal wall abscess.(b)(6) 2016: ventral incisional hernia repair, s/p [status post] incision and drainage [i&d] of small abscess of abdominal wound, positive for mrsa.Implant preoperative complaints: (b)(6) 2016: ¿states currently on antibiotics.Was scheduled for hernia repair last week but was canceled due to infection.Positive abdominal pain.Abdomen: 2 cm open wound along previous midline surgical scar; beefy, red granulation tissue.Impression/plan: incisional hernia.Continue leaquin [sic], saline wet to dry dressing changes.Follow up 2 weeks.Aerobic culture reveals mrsa abdominal wound; prescribed levaquin.¿ (b)(6) 2016: ¿follow up s/p [status post] incisional hernia.Finished levaquin.Ros [review of symptoms]: skin lesion.Exam abdomen: wound healed, no signs of infection or fluctuance.Assessment: incisional hernia without obstruction or gangrene.Plan: s/p i&d small abcess [sic] abdominal wound.Has mrsa infection, treated w/ antibiotics, now healed, will proceed with repair [sic] of vental [sic] incisional hernia.¿ (b)(6) 2016: ¿has questions about upcoming surgery.States he would rather have stitches than mesh; he doesn¿t think the mesh is right for him.Spoke with patient about concerns.¿ (b)(6) 2017: ¿the patient a 65-year-old gentleman who previously underwent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.¿ implant procedure: repair of ventral incisional hernia with a 20 x 25 cm sheet of ¿synecor¿.Implant: gore® synecor biomaterial ((b)(4)) 20 cm x 25 cm.Implant date: (b)(6) 2017 [hospitalization dates unknown].Description of hernia being treated: ¿a skin incision was then made directly overlying the hernia.Subcutaneous tissues were divided until we had identified the hernia sac which was then opened and the abdominal cavity was then entered.There were some adhesions to the hernia sac and these were taken down using both blunt as well as sharp dissection until we had fully exposed the hernia defect.We then prepared the posterior fascia by removing all adhesions, again with both blunt and sharp dissection.We then excised the hernia sac with the bovie cautery in a circumferential fashion, passed this from the table.The anterior fascia was also prepared so that we could achieve a 5 cm overlap in a circumferential fashion for the hernia repair, this required a 20 x 25 cm sheet of synecor as the hernia defect measured approximately 9 to 10 cm x 12 cm.¿ implant size and fixation: ¿we then placed the synecor in the proper orientation, this was secured in place with interrupted sutures of #1 prolene in a u-stitch fashion achieving a 5 cm overlap of the hernia defect circumferentially.Once the hernia had been repaired, hemostasis was achieved with the bovie cautery.The wound was copiously irrigated with saline solution until all irrigant was clear.Gentamicin 160 mg was then instilled onto the mycromesh [sic].Two large flat jp drains were then placed through separate stab incisions, one in the right lower quadrant, on in the left lower quadrant placed into the wound and secured in place with single sutures of 2-0 silk.The subcutaneous tissues were closed.It should be noted that the umbilicus was tacked back to the fascia with a single suture of 2-0 vicryl.The 2-0 vicryl was also used to reapproximate the subcutaneous tissues in a running fashion.Skin was closed with staples.¿ post-operative period: [six days]. (b)(6) 2017: ¿previous exploratory laparotomy and small bowel resection for perforated jejunal diverticulitis.Develop bulging previous surgical site, developed large ventral incisional hernia.Hospital course: admitted postoperatively given pca pump for pain.Increase activity level.Positive flatus, bowel movements.Midline surgical site well approximated.Staples, sutures intact.Jp drains x2.Serosanguineous fluid noted.Diet advanced, tolerated, continued feel better, discharged home.¿ relevant medical information: (b)(6) 2017: ¿exam: abdomen; midline staples, jp drains x2 removed.Mastisol, steri-strips, tegaderm dressing applied.No erythema or dehiscence noted.10 ml serosanguinous fluid in jp drains.¿ (b)(6) 2017: ct abdomen/pelvis: ¿status post interval anterior abdominal wall hernia repair with moderated fluid density superficial to the hernia mesh with small foci of air.This may represent an inflammatory or infectious process.¿ hospitalization on (b)(6) 2017. (b)(6) 2017: ¿had ventral incisional hernia developed from previous exploratory laparotomy surgical site.Uneventful postop period, repair ventral incisional hernia doing well, staples.Presented back to emergency room due to complaints of fever, chills.Pain around periumbilical region.Denies change in bowel habits.Ct scan of abdomen/pelvis w/o contrast, moderate fluid density superficial to hernia mesh, small foci of air, no free air or fluid identified, may represent inflammatory infectious process.¿ ¿abdomen soft, slightly tender to palpation right midline surgical scar.No erythema or drainage.¿ (b)(6) 2017: ultrasound-guided abdominal wall aspiration: ¿under ultrasound guidance, centesis catheter introduced into the collection with aspiration of 130 ml cloudy yellow fluid.Drain is not accessible at this time for placement.Catheter removed.¿ (b)(6) 2017: microbiology: ¿heavy growth of methicillin resistant staphylococcus aureus (mrsa) with light growth of klebsiella oxytoca.¿ (b)(6) 2017: ct abdomen/pelvis: ¿there continues to be fluid in the subcutaneous tissues anterior to the mesh.There continues to be some bubbles of gas present within the fluid suggesting that it may be infected.¿ (b)(6) 2017: exploration of abdominal wound with wound vac placement: ¿following appropriate anesthesia, 10 blade scalpel then used, and incision was then created between the three small punctate incisions present on the anterior abdominal wall with positive drainage.Incision was deepened down through the skin into the subcutaneous tissue and the incision was then lengthened appropriately to allow direct visualization of the underlying mesh.Following this periods, a copious amounts of approximately 1 l of bacitracin saline solution was then used with the surgilav irrigation device and the wound was irrigated.Prior to irrigation, please note that aerobic and anaerobic cultures were obtained.Following the irrigation, there was good viable tissue noted.No signs or symptoms of infection.At this time, i then placed verso foam in the base of the wound and covered with granular foam.The occlusive dressing was then placed on top of the wound itself; small incision was created in the central portion of the granular foam and the occlusive dressing.The tubing was then attached to the wound vac itself.Wound vac was then placed to 125 mmhg pressure continuous.No leaks were detected.¿ (b)(6) 2017: microbiology: ¿abdominal wound (contam).1.Anaerobic culture: (b)(6) 2017: no growth on primary plates; broth culture negative at 48 hours, final report to follow.(b)(6) 2017: no anaerobes isolated.¿ (b)(6) 2017: discharge summary: ¿underwent open ventral hernia repair.Developed seroma with questionable abscess.Admitted, started on iv antibiotics.Seen by interventional radiology and abdominal fluid collection aspirated with cloudy fluid obtained.Continued drainage from abdomen.Taken on (b)(6) 2017 to operating room for exploration of abdominal wound with wound vac placement.Transferred to surgical floor.Continued to feel better.Tolerating regular diet.Had flatus and bowel movements.¿ (b)(6) 2017: ¿wound location: lower mid abdominal.Length: 7.Width: 3.Depth: 1.Dehiscence of surgical wound.Wound closure: packing, wound vac.Drainage amount: scant.Type: serosanguinous, bloody/frank blood.Undermining wound: tract <2cm.Appearance wound bed: pink/red (granulation).Wound care provided: soiled dressing removed, wound cleansed, drainage system emptied-100ml, wound packed white foam, black foam, dressing applied.No ss [signs or symptoms] infection.¿ (b)(6) 2017: ¿denies pain.Wound location: abdomen.Length: 6.5.Width: 2.Depth: 1.Type: surgical wound.Drainage amount wound: small.Type: serosanguinous.Appearance of wound bed: pink/red (granulation).Clinical note: wound vac intact, running at 125.Removed vac, old dressing.Wound cleaned; white foam placed in wound bed.¿ (b)(6) 2017: ¿status post exploration of abdominal wound with wound vac placement.Abdomen: midline abdominal surgical site has wound vac dressing; removed with pink granulation tissue noted.Wound healing without signs of infection.¿ (b)(6) 2017: ¿wound location: abdomen.Wound: length: 4.5.Width: 1.5.Depth: 0.3.Type: dehiscence surgical wound.Closure: vac.Drainage amount wound: scant.Type: serous.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: lpn [licensed practical nurse] arrived at home find pt driving up driveway.Lpn asked if he know about homebound status and he states ¿i will go wherever i want to.¿ lpn explained pt needs to be homebound to continue with care, he said ¿well i can just go to the dr and get it done because i don¿t need you people anymore it¿s all about money anyways.¿ lpn asked to do wound vac, he voiced understanding.¿ (b)(6) 2017: discharge summary from wound care program: ¿pt discharged after difficulties locating for routine visits and being out driving to other counties during days of planned visits.¿ (b)(6) 2017: ¿dehisced wound present at center of abdomen.Wound appears relatively shallow; base is granular.Plan: hold wound vac.Pt instructed not to return vac.Continue wound care w/ aquacel ag.Perform daily dressing changes.Consider surgical debridement in or, pending status wound next f/u [follow up].¿ (b)(6) 2017: ¿midline abdominal wound healing well, beefy red granulation tissue.Wound bed shallow.Redressed with aquacel and 4x4, tape.¿ (b)(6) 2017: ¿presents with pain in area repair incisional hernia (b)(6) 2017.Been coughing a lot, thinks had recurrence.Reports gas, bloating when eats.Assessment: abdominal pain, bloating.Plan: dr.(b)(6) believes the mesh is causing pain.Avoid lifting over 15-20 lbs., wear binder.Dr.States hernia site continue to bulge because still a break in fasca [sic].Avoid activity that cause recurrence.¿ (b)(6) 2017: ¿presents with mass on stomach.Mass is black at center and raised.Pt thinks he has staph infection in intestines.Mass next to umbilical/abdominal scar.Assessment: cutaneous abscess of abdominal wall.¿ (b)(6) 2017: microbiology: ¿source: wound abdomen.Heavy growth of methicillin resistant staphylococcus aureus (mrsa).¿ (b)(6) 2017: ¿cutaneous abscess of abdominal wall.Currently taking augmentin with improvement in abscess.Aerobic culture reveals sensitivity to bactrim and levaquin.Stomach pain with bactrim.Stop augmentin.Start levaquin for 14 days.¿ (b)(6) 2017: ct abdomen/pelvis: ¿large ventral hernia region of prior hernia repair.Small focal additional herniation along inferior and right lateral margin of prior placed hernia mesh.Anterior abdominal wall musculature atrophied.¿ (b)(6) 2017: ¿ros [review of symptoms]: abdominal pain.Assessment: ventral hernia.Plan: not in physical condition to undergo s/x [surgery] atm [at the moment].Continue current wound care.Continue wearing binder, avoid strenuous activity, lifting over 10 lbs.¿ (b)(6) 2017: ¿disk from outside hospital demonstrating large ventral hernia containing multiple nonobstructive small bowel and colonic segments.Defect measures 8-10 cm across.Exam, large ventral hernia containing loops of bowel, partially compressible.Midline scar healed, no open wounds.Plan ventral hernia repair using sheet of mesh, release of lateral abdominal wall with component separation, mesh strip repair of anterior rectus sheath and muscle.Bactroban ointment to bilateral nares for 7 days prior to surgery, hx [history] of multiple staph infections and likelihood he is chronically colonized with staph.¿ (b)(6) 2017: emergency room: ¿complains of assault.Hit in abdomen as well.Significant history of abdominal surgeries; another surgery in two weeks.States increased amount of swelling form abdomen after being hit.Abdomen: firm, mild tenderness; diffuse, erythema noted.¿ (b)(6) 2017: ct abdomen/pelvis: ¿redemonstration of prior postoperative changes of ventral hernia repair with mesh with large ventral hernia containing non-dilated loops of small and large bowel.¿ explant preoperative complaints: (b)(6) 2017: ¿exam: abd [abdomen] -well healed midline scar, tender to palpation at inferior aspect, midline hernia.Plan: to or for components release, hernia repair, abdominoplasty.¿ explant procedure: removal of previously placed hernia mesh.Repair of midline ventral hernia with bilateral sliding myofascial rectus abdominis flaps and use of retrorectus soft prolene mesh.Vertical abdominoplasty.Explant date: (b)(6) 2017 [hospitalization dates unknown] ¿previous midline incision was opened after carefully marking his midline structures, and we got into the abdomen without difficulty.The incision was made from the xiphoid all the way to the symphysis pubis.After completely freeing the midline incision, we divided the old mesh in half, and his hernia was approximately 12 cm in transverse dimension by ct scan.Carefully, the mesh was dissected free from surrounding tissues and the prolenes that were holding it in place.It seemed to be a polyester type mesh.There were no bowel injuries.After excising the mesh and the posterior aspect of the abdominal wall, skin flaps were elevated for [illegible] cm off of the anterior rectus fascia for the length of the closure.There was no way to bring the muscles and soft tissues to the midline.Therefore, bilateral sliding myofascial rectus abdominis flaps were created.On the right side, through a 6 cm transverse incision, dissection down to the right semilunar line was performed.The right external oblique muscle and fascia was divided from farther above the rib cage down to the level past the anterior superior iliac spine through this transverse incision.The deep fascia of the external oblique was divided, and external oblique was mobilized off of the internal oblique.Identical procedure was performed on the left-hand side to create a left-sided myofascial rectus abdominis flap.Dissection through the 6 cm incision was made, and tissue was elevated off the semilunar lines.The left external oblique muscle and fascia was then divided to create a left-sided myofascial rectus abdominis flap.At this point, we got into the retrorectus space, though there was a scarring from the prior mesh placement, we were able to get to reasonable posterior fascia.However, superiorly, it will be difficult to get the posterior fascia completely closed.Therefore, in an inferior to superior direction, the closure was then performed.We closed a bit of the posterior fascia, and then used both mesh strips for the anterior rectus fascia, and retrorectus mesh 7.5 cm wide, with bites [illegible] cm from the medical border of the rectus muscle to help bring the rectus muscles together.Bringing [sic] the anterior muscles together, brought the posterior fascia toward the midline along with it.Therefore, we essentially [illegible] up the fascia from inferior to superior, closing some posterior fascia, then closing the muscle, and then closing anterior fascia, and doing these maneuvers in this way, we got the posterior fascia completely closed.Then, the final mesh sutures were used to bring the medial border of the rectus muscles to the midline.Two drains were placed in the midline, and 1 in each of the release sites.The skin then had its abdominoplasty.After carefully undermining, we were able to excise a good amount of skin in a vertical pattern.We used pumpkin-teeth flaps to create a neoumbilicus.The skin was then closed after hemostasis achieved with 3-0 vicryl suture and a [illegible] -0 monocryl suture.¿ records indicate a non-gore device was implanted during the (b)(6) 2017 procedure.Relevant medical information: (b)(6) 2017: ¿wounds clean, without excessive erythema, non-inflamed, incisions are clean, dry, intact minimal tenderness, without erythema or swelling.¿ (b)(6) 2017: ¿post-operative day 2 after abdominoplasty with adequate pain control from thoracic epidural and pcea [patient controlled epidural analgesia].Pruritis remains issue but under control.Pain under good control.¿ (b)(6) 2017: discharge summary: ¿admitted following surgery, return bowel function, recovery from anesthesia, general surgical observation.No acute events, discharged home.F/u in office.¿ conclusion: it should be noted that the gore® synecor biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence.¿ the gore® synecor biomaterial instructions for use warns, ¿as with any mesh, use of gore® synecor biomaterial in contaminated fields may require removal of the mesh if infection occurs.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Previous patient code (3190) was reported based on the original complaint and is no longer applicable and/or not reportable per gore¿s investigation.The following information was determined from the medical records.Medical records: the known medical records span (b)(6) 1997 through (b)(6) 2018 and not all records received in this time span are relevant to the gore® synecor biomaterial.Patient information: medical history: hypertension; hyperlipidemia; hiatal hernia; gastroesophageal reflux disease; gastritis; duodenitis; chronic abdominal pain; perforated proximal jejunum diverticulum; wound disruption; ventral hernia; diastasis recti; methicillin resistant staphylococcus aureus [mrsa] infection of abdominal wound; perforated viscus.Prior surgical procedures: (b)(6) 2016: emergent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis; (b)(6) 2016: i&d of abdominal wall abscess; (b)(6) 2016: ventral incisional hernia repair, s/p [status post] incision and drainage [i&d] of small abscess of abdominal wound, positive for mrsa.Implant preoperative complaints: (b)(6) 2016: ¿states currently on antibiotics.Was scheduled for hernia repair last week but was canceled due to infection.Positive abdominal pain.Abdomen: 2 cm open wound along previous midline surgical scar; beefy, red granulation tissue.Impression/plan: incisional hernia.Continue leaquin [sic], saline wet to dry dressing changes.Follow up 2 weeks.Aerobic culture reveals mrsa abdominal wound; prescribed levaquin.¿ (b)(6) 2016: ¿follow up s/p [status post] incisional hernia.Finished levaquin.Ros [review of symptoms]: skin lesion.Exam abdomen: wound healed, no signs of infection or fluctuance.Assessment: incisional hernia without obstruction or gangrene.Plan: s/p i&d small abcess [sic] abdominal wound.Has mrsa infection, treated w/ antibiotics, now healed, will proceed with repaur [sic] of vental [sic] incisional hernia.¿ (b)(6) 2016: ¿has questions about upcoming surgery.States he would rather have stitches than mesh; he doesn¿t think the mesh is right for him.Spoke with patient about concerns.¿ (b)(6) 2017: ¿the patient a 65-year-old gentleman who previously underwent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.¿ implant procedure: repair of ventral incisional hernia with a 20 x 25 cm sheet of ¿synecor¿.Implant: gore® synecor biomaterial (15010513/gkfr2025) 20 cm x 25 cm.Implant date: (b)(6) 2017 [hospitalization dates unknown].Description of hernia being treated: ¿a skin incision was then made directly overlying the hernia.Subcutaneous tissues were divided until we had identified the hernia sac which was then opened and the abdominal cavity was then entered.There were some adhesions to the hernia sac and these were taken down using both blunt as well as sharp dissection until we had fully exposed the hernia defect.We then prepared the posterior fascia by removing all adhesions, again with both blunt and sharp dissection.We then excised the hernia sac with the bovie cautery in a circumferential fashion, passed this from the table.The anterior fascia was also prepared so that we could achieve a 5 cm overlap in a circumferential fashion for the hernia repair, this required a 20 x 25 cm sheet of synecor as the hernia defect measured approximately 9 to 10 cm x 12 cm.¿ implant size and fixation: ¿we then placed the synecor in the proper orientation, this was secured in place with interrupted sutures of #1 prolene in a u-stitch fashion achieving a 5 cm overlap of the hernia defect circumferentially.Once the hernia had been repaired, hemostasis was achieved with the bovie cautery.The wound was copiously irrigated with saline solution until all irrigant was clear.Gentamicin 160 mg was then instilled onto the mycromesh [sic].Two large flat jp drains were then placed through separate stab incisions, one in the right lower quadrant, on in the left lower quadrant placed into the wound and secured in place with single sutures of 2-0 silk.The subcutaneous tissues were closed.It should be noted that the umbilicus was tacked back to the fascia with a single suture of 2-0 vicryl.The 2-0 vicryl was also used to reapproximate the subcutaneous tissues in a running fashion.Skin was closed with staples.¿ post-operative period: [six days] (b)(6) 2017: ¿previous exploratory laparotomy and small bowel resection for perforated jejunal diverticulitis.Develop bulging previous surgical site, developed large ventral incisional hernia.Hospital course: admitted postoperatively given pca pump for pain.Increase activity level.Positive flatus, bowel movements.Midline surgical site well approximated.Staples, sutures intact.Jp drains x2.Serosanguineous fluid noted.Diet advanced, tolerated, continued feel better, discharged home.¿ relevant medical information: (b)(6) 2017: ¿exam: abdomen; midline staples, jp drains x2 removed.Mastisol, steri-strips, tegaderm dressing applied.No erythema or dehiscence noted.10 ml serosanguinous fluid in jp drains.¿ (b)(6) 2017: ct abdomen/pelvis: ¿status post interval anterior abdominal wall hernia repair with moderated fluid density superficial to the hernia mesh with small foci of air.This may represent an inflammatory or infectious process.¿ hospitalization (b)(6) 2017. (b)(6) 2017: ¿had ventral incisional hernia developed from previous exploratory laparotomy surgical site.Uneventful postop period, repair ventral incisional hernia doing well, staples.Presented back to emergency room due to complaints of fever, chills.Pain around periumbilical region.Denies change in bowel habits.Ct scan of abdomen/pelvis w/o contrast, moderate fluid density superficial to hernia mesh, small foci of air, no free air or fluid identified, may represent inflammatory infectious process.¿ ¿abdomen soft, slightly tender to palpation right midline surgical scar.No erythema or drainage.¿ (b)(6) 2017: ultrasound-guided abdominal wall aspiration: ¿under ultrasound guidance, centesis catheter introduced into the collection with aspiration of 130 ml cloudy yellow fluid.Drain is not accessible at this time for placement.Catheter removed.¿ (b)(6) 2017: microbiology: ¿heavy growth of methicillin resistant staphylococcus aureus (mrsa) with light growth of klebsiella oxytoca.¿ (b)(6) 2017: ct abdomen/pelvis: ¿there continues to be fluid in the subcutaneous tissues anterior to the mesh.There continues to be some bubbles of gas present within the fluid suggesting that it may be infected.¿ (b)(6) 2017: exploration of abdominal wound with wound vac placement: ¿following appropriate anesthesia, 10 blade scalpel then used, and incision was then created between the three small punctate incisions present on the anterior abdominal wall with positive drainage.Incision was deepened down through the skin into the subcutaneous tissue and the incision was then lengthened appropriately to allow direct visualization of the underlying mesh.Following this periods, a copious amounts of approximately 1 l of bacitracin saline solution was then used with the surgilav irrigation device and the wound was irrigated.Prior to irrigation, please note that aerobic and anaerobic cultures were obtained.Following the irrigation, there was good viable tissue noted.No signs or symptoms of infection.At this time, i then placed verso foam in the base of the wound and covered with granular foam.The occlusive dressing was then placed on top of the wound itself; small incision was created in the central portion of the granular foam and the occlusive dressing.The tubing was then attached to the wound vac itself.Wound vac was then placed to 125 mmhg pressure continuous.No leaks were detected.¿ (b)(6) 2017: microbiology: ¿abdominal wound (contam).1.Anaerobic culture: (b)(6) 2017: no growth on primary plates; broth culture negative at 48 hours, final report to follow.(b)(6) 2017: no anaerobes isolated.¿ (b)(6) 2017: discharge summary: ¿underwent open ventral hernia repair.Developed seroma with questionable abscess.Admitted, started on iv antibiotics.Seen by interventional radiology and abdominal fluid collection aspirated with cloudy fluid obtained.Continued drainage from abdomen.Taken on (b)(6) 2017 to operating room for exploration of abdominal wound with wound vac placement.Transferred to surgical floor.Continued to feel better.Tolerating regular diet.Had flatus and bowel movements.¿ (b)(6) 2017: ¿wound location: lower mid abdominal.Length: 7.Width: 3.Depth: 1.Dehiscence of surgical wound.Wound closure: packing, wound vac.Drainage amount: scant.Type: serosanguinous, bloody/frank blood.Undermining wound: tract <2cm.Appearance wound bed: pink/red (granulation).Wound care provided: soiled dressing removed, wound cleansed, drainage system emptied-100ml, wound packed white foam, black foam, dressing applied.No ss [signs or symptoms] infection.¿ (b)(6) 2017: ¿denies pain.Wound location: abdomen.Length: 6.5.Width: 2.Depth: 1.Type: surgical wound.Drainage amount wound: small.Type: serosanguinous.Appearance of wound bed: pink/red (granulation).Clinical note: wound vac intact, running at 125.Removed vac, old dressing.Wound cleaned; white foam placed in wound bed.¿ (b)(6) 2017: ¿status post exploration of abdominal wound with wound vac placement.Abdomen: midline abdominal surgical site has wound vac dressing; removed with pink granulation tissue noted.Wound healing without signs of infection.¿ (b)(6) 2017: ¿wound location: abdomen.Wound: length: 4.5.Width: 1.5.Depth: 0.3.Type: dehiscence surgical wound.Closure: vac.Drainage amount wound: scant.Type: serous.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: lpn [licensed practical nurse] arrived at home find pt driving up driveway.Lpn asked if he know about homebound status and he states ¿i will go wherever i want to.¿ lpn explained pt needs to be homebound to continue with care, he said ¿well i can just go to the dr and get it done because i don¿t need you people anymore it¿s all about money anyways.¿ lpn asked to do wound vac, he voiced understanding.¿ (b)(6) 2017: discharge summary from wound care program: ¿pt discharged after difficulties locating for routine visits and being out driving to other counties during days of planned visits.¿ (b)(6) 2017: ¿dehisced wound present at center of abdomen.Wound appears relatively shallow; base is granular.Plan: hold wound vac.Pt instructed not to return vac.Continue wound care w/ aquacel ag.Perform daily dressing changes.Consider surgical debridement in or, pending status wound next f/u [follow up].¿ (b)(6) 2017: ¿midline abdominal wound healing well, beefy red granulation tissue.Wound bed shallow.Redressed with aquacel and 4x4, tape.¿ (b)(6) 2017: ¿presents with pain in area repair incisional hernia (b)(6) 2017.Been coughing a lot, thinks had recurrence.Reports gas, bloating when eats.Assessment: abdominal pain, bloating.Plan: dr.(b)(6) believes the mesh is causing pain.Avoid lifting over 15-20 lbs., wear binder.Dr.States hernia site continue to bulge because still a break in fasca [sic].Avoid activity that cause recurrence.¿ (b)(6) 2017: ¿presents with mass on stomach.Mass is black at center and raised.Pt thinks he has staph infection in intestines.Mass next to umbilical/abdominal scar.Assessment: cutaneous abscess of abdominal wall.¿ (b)(6) 2017: microbiology: ¿source: wound abdomen.Heavy growth of methicillin resistant staphylococcus aureus (mrsa).¿ (b)(6) 2017: ¿cutaneous abscess of abdominal wall.Currently taking augmentin with improvement in abscess.Aerobic culture reveals sensitivity to bactrim and levaquin.Stomach pain with bactrim.Stop augmentin.Start levaquin for 14 days.¿ (b)(6) 2017: ct abdomen/pelvis: ¿large ventral hernia region of prior hernia repair.Small focal additional herniation along inferior and right lateral margin of prior placed hernia mesh.Anterior abdominal wall musculature atrophied.¿ (b)(6) 2017: ¿ros [review of symptoms]: abdominal pain.Assessment: ventral hernia.Plan: not in physical condition to undergo s/x [surgery] atm [at the moment].Continue current wound care.Continue wearing binder, avoid strenuous activity, lifting over 10 lbs.¿ (b)(6) 2017: ¿disk from outside hospital demonstrating large ventral hernia containing multiple nonobstructive small bowel and colonic segments.Defect measures 8-10 cm across.Exam, large ventral hernia containing loops of bowel, partially compressible.Midline scar healed, no open wounds.Plan ventral hernia repair using sheet of mesh, release of lateral abdominal wall with component separation, mesh strip repair of anterior rectus sheath and muscle.Bactroban ointment to bilateral nares for 7 days prior to surgery, hx [history] of multiple staph infections and likelihood he is chronically colonized with staph.¿ (b)(6) 2017: emergency room: ¿complains of assault.Hit in abdomen as well.Significant history of abdominal surgeries; another surgery in two weeks.States increased amount of swelling form abdomen after being hit.Abdomen: firm, mild tenderness; diffuse, erythema noted.¿ (b)(6) 2017: ct abdomen/pelvis: ¿redemonstration of prior postoperative changes of ventral hernia repair with mesh with large ventral hernia containing non-dilated loops of small and large bowel.¿ explant preoperative complaints: (b)(6) 2017: ¿exam: abd [abdomen] -well healed midline scar, tender to palpation at inferior aspect, midline hernia.Plan: to or for components release, hernia repair, abdominoplasty.¿ explant procedure: removal of previously placed hernia mesh.Repair of midline ventral hernia with bilateral sliding myofascial rectus abdominis flaps and use of retrorectus soft prolene mesh.Vertical abdominoplasty.Explant date: (b)(6) 2017 [hospitalization dates unknown].¿previous midline incision was opened after carefully marking his midline structures, and we got into the abdomen without difficulty.The incision was made from the xiphoid all the way to the symphysis pubis.After completely freeing the midline incision, we divided the old mesh in half, and his hernia was approximately 12 cm in transverse dimension by ct scan.Carefully, the mesh was dissected free from surrounding tissues and the prolenes that were holding it in place.It seemed to be a polyester type mesh.There were no bowel injuries.After excising the mesh and the posterior aspect of the abdominal wall, skin flaps were elevated for [illegible] cm off of the anterior rectus fascia for the length of the closure.There was no way to bring the muscles and soft tissues to the midline.Therefore, bilateral sliding myofascial rectus abdominis flaps were created.On the right side, through a 6 cm transverse incision, dissection down to the right semilunar line was performed.The right external oblique muscle and fascia was divided from farther above the rib cage down to the level past the anterior superior iliac spine through this transverse incision.The deep fascia of the external oblique was divided, and external oblique was mobilized off of the internal oblique.Identical procedure was performed on the left-hand side to create a left-sided myofascial rectus abdominis flap.Dissection through the 6 cm incision was made, and tissue was elevated off the semilunar lines.The left external oblique muscle and fascia was then divided to create a left-sided myofascial rectus abdominis flap.At this point, we got into the retrorectus space, though there was a scarring from the prior mesh placement, we were able to get to reasonable posterior fascia.However, superiorly, it will be difficult to get the posterior fascia completely closed.Therefore, in an inferior to superior direction, the closure was then performed.We closed a bit of the posterior fascia, and then used both mesh strips for the anterior rectus fascia, and retrorectus mesh 7.5 cm wide, with bites [illegible] cm from the medical border of the rectus muscle to help bring the rectus muscles together.Brining [sic] the anterior muscles together, brought the posterior fascia toward the midline along with it.Therefore, we essentially [illegible] up the fascia from inferior to superior, closing some posterior fascia, then closing the muscle, and then closing anterior fascia, and doing these maneuvers in this way, we got the posterior fascia completely closed.Then, the final mesh sutures were used to bring the medial border of the rectus muscles to the midline.Two drains were placed in the midline, and 1 in each of the release sites.The skin then had its abdominoplasty.After carefully undermining, we were able to excise a good amount of skin in a vertical pattern.We used pumpkin-teeth flaps to create a neoumbilicus.The skin was then closed after hemostasis achieved with 3-0 vicryl suture and a [illegible] -0 monocryl suture.¿ records indicate a non-gore device was implanted during the (b)(6) 2017 procedure.Relevant medical information: (b)(6) 2017: ¿wounds clean, without excessive erythema, non-inflamed, incisions are clean, dry, intact minimal tenderness, without erythema or swelling.¿ (b)(6) 2017: ¿post-operative day 2 after abdominoplasty with adequate pain control from thoracic epidural and pcea [patient controlled epidural analgesia].Pruritis remains issue but under control.Pain under good control.¿ (b)(6) 2017: discharge summary: ¿admitted following surgery, return bowel function, recovery from anesthesia, general surgical observation.No acute events, discharged home.F/u in office.¿ conclusion: it should be noted that the gore® synecor biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence.¿ the gore® synecor biomaterial instructions for use warns, ¿as with any mesh, use of gore® synecor biomaterial in contaminated fields may require removal of the mesh if infection occurs.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated health effect- clinical code.H6: updated investigation findings.H6: updated investigation conclusion.H6: health effect impact code: f26: no health consequences or impact.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Previous patient code (3190) was reported based on the original complaint and is no longer applicable and/or not reportable per gore¿s investigation.Medical records: the known medical records span july 1, 1997 through november 11, 2018 and not all records received in this time span are relevant to the gore® synecor biomaterial.Patient information: medical history: hypertension, hyperlipidemia, hiatal hernia, gastroesophageal reflux disease, gastritis, duodenitis, chronic abdominal pain, perforated proximal jejunum diverticulum, wound disruption, ventral hernia, diastasis recti, methicillin resistant staphylococcus aureus [mrsa] infection of abdominal wound, perforated viscus, prior surgical procedures: (b)(6) 2016: emergent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.(b)(6) 2016: i&d of abdominal wall abscess.(b)(6) 2016: ventral incisional hernia repair, s/p [status post] incision and drainage [i&d] of small abscess of abdominal wound, positive for mrsa.Implant preoperative complaints: (b)(6) 2016: ¿states currently on antibiotics.Was scheduled for hernia repair last week but was canceled due to infection.Positive abdominal pain.Abdomen: 2 cm open wound along previous midline surgical scar; beefy, red granulation tissue.Impression/plan: incisional hernia.Continue leaquin [sic], saline wet to dry dressing changes.Follow up 2 weeks.Aerobic culture reveals mrsa abdominal wound; prescribed levaquin.¿ (b)(6) 2016: ¿follow up s/p [status post] incisional hernia.Finished levaquin.Ros [review of symptoms]: skin lesion.Exam abdomen: wound healed, no signs of infection or fluctuance.Assessment: incisional hernia without obstruction or gangrene.Plan: s/p i&d small abcess [sic] abdominal wound.Has mrsa infection, treated w/ antibiotics, now healed, will proceed with repaur [sic] of vental [sic] incisional hernia.¿ (b)(6) 2016: ¿has questions about upcoming surgery.States he would rather have stitches than mesh; he doesn¿t think the mesh is right for him.Spoke with patient about concerns.¿ (b)(6) 2017: ¿the patient a 65-year-old gentleman who previously underwent exploratory laparotomy, small bowel resection for perforated jejunal diverticulitis.¿ implant procedure: repair of ventral incisional hernia with a 20 x 25 cm sheet of ¿synecor¿.Implant: gore® synecor biomaterial (15010513/gkfr2025) 20 cm x 25 cm.Implant date: (b)(6) 2017.Description of hernia being treated: ¿a skin incision was then made directly overlying the hernia.Subcutaneous tissues were divided until we had identified the hernia sac which was then opened and the abdominal cavity was then entered.There were some adhesions to the hernia sac and these were taken down using both blunt as well as sharp dissection until we had fully exposed the hernia defect.We then prepared the posterior fascia by removing all adhesions, again with both blunt and sharp dissection.We then excised the hernia sac with the bovie cautery in a circumferential fashion, passed this from the table.The anterior fascia was also prepared so that we could achieve a 5 cm overlap in a circumferential fashion for the hernia repair, this required a 20 x 25 cm sheet of synecor as the hernia defect measured approximately 9 to 10 cm x 12 cm.¿ implant size and fixation: ¿we then placed the synecor in the proper orientation, this was secured in place with interrupted sutures of #1 prolene in a u-stitch fashion achieving a 5 cm overlap of the hernia defect circumferentially.Once the hernia had been repaired, hemostasis was achieved with the bovie cautery.The wound was copiously irrigated with saline solution until all irrigant was clear.Gentamicin 160 mg was then instilled onto the mycromesh [sic].Two large flat jp drains were then placed through separate stab incisions, one in the right lower quadrant, on in the left lower quadrant placed into the wound and secured in place with single sutures of 2-0 silk.The subcutaneous tissues were closed.It should be noted that the umbilicus was tacked back to the fascia with a single suture of 2-0 vicryl.The 2-0 vicryl was also used to reapproximate the subcutaneous tissues in a running fashion.Skin was closed with staples.¿ post-operative period: [six days]. (b)(6) 2017: ¿previous exploratory laparotomy and small bowel resection for perforated jejunal diverticulitis.Develop bulging previous surgical site, developed large ventral incisional hernia.Hospital course: admitted postoperatively given pca pump for pain.Increase activity level.Positive flatus, bowel movements.Midline surgical site well approximated.Staples, sutures intact.Jp drains x2.Serosanguineous fluid noted.Diet advanced, tolerated, continued feel better, discharged home.¿ relevant medical information: (b)(6) 2017: ¿exam: abdomen; midline staples, jp drains x2 removed.Mastisol, steri-strips, tegaderm dressing applied.No erythema or dehiscence noted.10 ml serosanguinous fluid in jp drains.¿ (b)(6) 2017: ct abdomen/pelvis: ¿status post interval anterior abdominal wall hernia repair with moderated fluid density superficial to the hernia mesh with small foci of air.This may represent an inflammatory or infectious process.¿ hospitalization (b)(6) 2017. (b)(6) 2017: ¿had ventral incisional hernia developed from previous exploratory laparotomy surgical site.Uneventful postop period, repair ventral incisional hernia doing well, staples.Presented back to emergency room due to complaints of fever, chills.Pain around periumbilical region.Denies change in bowel habits.Ct scan of abdomen/pelvis w/o contrast, moderate fluid density superficial to hernia mesh , small foci of air, no free air or fluid identified, may represent inflammatory infectious process.¿ ¿abdomen soft, slightly tender to palpation right midline surgical scar.No erythema or drainage.¿ (b)(6) 2017: ultrasound-guided abdominal wall aspiration: ¿under ultrasound guidance, centesis catheter introduced into the collection with aspiration of 130 ml cloudy yellow fluid.Drain is not accessible at this time for placement.Catheter removed.¿ (b)(6) 2017: microbiology: ¿heavy growth of methicillin resistant staphylococcus aureus (mrsa) with light growth of klebsiella oxytoca.¿ (b)(6) 2017: ct abdomen/pelvis: ¿there continues to be fluid in the subcutaneous tissues anterior to the mesh.There continues to be some bubbles of gas present within the fluid suggesting that it may be infected.¿ (b)(6) 2017: exploration of abdominal wound with wound vac placement: ¿following appropriate anesthesia, 10 blade scalpel then used, and incision was then created between the three small punctate incisions present on the anterior abdominal wall with positive drainage.Incision was deepened down through the skin into the subcutaneous tissue and the incision was then lengthened appropriately to allow direct visualization of the underlying mesh.Following this periods, a copious amounts of approximately 1 l of bacitracin saline solution was then used with the surgilav irrigation device and the wound was irrigated.Prior to irrigation, please note that aerobic and anaerobic cultures were obtained.Following the irrigation, there was good viable tissue noted.No signs or symptoms of infection.At this time, i then placed verso foam in the base of the wound and covered with granular foam.The occlusive dressing was then placed on top of the wound itself; small incision was created in the central portion of the granular foam and the occlusive dressing.The tubing was then attached to the wound vac itself.Wound vac was then placed to 125 mmhg pressure continuous.No leaks were detected.¿ (b)(6) 2017: microbiology: ¿abdominal wound (contam).1.Anaerobic culture: (b)(6) 2017: no growth on primary plates; broth culture negative at 48 hours, final report to follow.(b)(6) 2017: no anaerobes isolated.¿ (b)(6) 2017: discharge summary: ¿underwent open ventral hernia repair.Developed seroma with questionable abscess.Admitted, started on iv antibiotics.Seen by interventional radiology and abdominal fluid collection aspirated with cloudy fluid obtained.Continued drainage from abdomen.Taken on (b)(6) 2017 to operating room for exploration of abdominal wound with wound vac placement.Transferred to surgical floor.Continued to feel better.Tolerating regular diet.Had flatus and bowel movements.¿ (b)(6) 2017: ¿wound location: lower mid abdominal.Length: 7.Width: 3.Depth: 1.Dehiscence of surgical wound.Wound closure: packing, wound vac.Drainage amount: scant.Type: serosanguinous, bloody/frank blood.Undermining wound: tract <2cm.Appearance wound bed: pink/red (granulation).Wound care provided: soiled dressing removed, wound cleansed, drainage system emptied-100ml, wound packed white foam, black foam, dressing applied.No ss [signs or symptoms] infection.¿ (b)(6) 2017: ¿denies pain.Wound location: abdomen.Length: 6.5.Width: 2.Depth: 1.Type: surgical wound.Drainage amount wound: small.Type: serosanguinous.Appearance of wound bed: pink/red (granulation).Clinical note: wound vac intact, running at 125.Removed vac, old dressing.Wound cleaned; white foam placed in wound bed.¿ (b)(6) 2017: ¿status post exploration of abdominal wound with wound vac placement.Abdomen: midline abdominal surgical site has wound vac dressing; removed with pink granulation tissue noted.Wound healing without signs of infection.¿ (b)(6) 2017: ¿wound location: abdomen.Wound: length: 4.5.Width: 1.5.Depth: 0.3.Type: dehiscence surgical wound.Closure: vac.Drainage amount wound: scant.Type: serous.Appearance wound bed: pink/red (granulation).Odor: no.Clinical note: lpn [licensed practical nurse] arrived at home find pt driving up driveway.Lpn asked if he know about homebound status and he states ¿i will go wherever i want to.¿ lpn explained pt needs to be homebound to continue with care, he said ¿well i can just go to the dr and get it done because i don¿t need you people anymore it¿s all about money anyways.¿ lpn asked to do wound vac, he voiced understanding.¿ (b)(6) 2017: discharge summary from wound care program: ¿pt discharged after difficulties locating for routine visits and being out driving to other counties during days of planned visits.¿ (b)(6) 2017: ¿dehisced wound present at center of abdomen.Wound appears relatively shallow; base is granular.Plan: hold wound vac.Pt instructed not to return vac.Continue wound care w/ aquacel ag.Perform daily dressing changes.Consider surgical debridement in or, pending status wound next f/u [follow up].¿ (b)(6) 2017: ¿midline abdominal wound healing well, beefy red granulation tissue.Wound bed shallow.Redressed with aquacel and 4x4, tape.¿ (b)(6) 2017: ¿presents with pain in area repair incisional hernia (b)(6) 2017.Been coughing a lot, thinks had recurrence.Reports gas, bloating when eats.Assessment: abdominal pain, bloating.Plan: dr.(b)(6) believes the mesh is causing pain.Avoid lifting over 15-20 lbs., wear binder.Dr.States hernia site continue to bulge because still a break in fasca [sic].Avoid activity that cause recurrence.¿ (b)(6) 2017: ¿presents with mass on stomach.Mass is black at center and raised.Pt thinks he has staph infection in intestines.Mass next to umbilical/abdominal scar.Assessment: cutaneous abscess of abdominal wall.¿ (b)(6) 2017: microbiology: ¿source: wound abdomen.Heavy growth of methicillin resistant staphylococcus aureus (mrsa).¿ (b)(6) 2017: ¿cutaneous abscess of abdominal wall.Currently taking augmentin with improvement in abscess.Aerobic culture reveals sensitivity to bactrim and levaquin.Stomach pain with bactrim.Stop augmentin.Start levaquin for 14 days.¿ (b)(6) 2017: ct abdomen/pelvis: ¿large ventral hernia region of prior hernia repair.Small focal additional herniation along inferior and right lateral margin of prior placed hernia mesh.Anterior abdominal wall musculature atrophied.¿ (b)(6) 2017: ¿ros [review of symptoms]: abdominal pain.Assessment: ventral hernia.Plan: not in physical condition to undergo s/x [surgery] atm [at the moment].Continue current wound care.Continue wearing binder, avoid strenuous activity, lifting over 10 lbs.¿ (b)(6) 2017 : ¿disk from outside hospital demonstrating large ventral hernia containing multiple nonobstructive small bowel and colonic segments.Defect measures 8-10 cm across.Exam, large ventral hernia containing loops of bowel, partially compressible.Midline scar healed, no open wounds.Plan ventral hernia repair using sheet of mesh, release of lateral abdominal wall with component separation, mesh strip repair of anterior rectus sheath and muscle.Bactroban ointment to bilateral nares for 7 days prior to surgery, hx [history] of multiple staph infections and likelihood he is chronically colonized with staph.¿ (b)(6) 2017: emergency room: ¿complains of assault.Hit in abdomen as well.Significant history of abdominal surgeries; another surgery in two weeks.States increased amount of swelling form abdomen after being hit.Abdomen: firm, mild tenderness; diffuse, erythema noted.¿ (b)(6) 2017: ct abdomen/pelvis: ¿redemonstration of prior postoperative changes of ventral hernia repair with mesh with large ventral hernia containing non-dilated loops of small and large bowel.¿ explant preoperative complaints: (b)(6) 2017: ¿exam: abd [abdomen] -well healed midline scar, tender to palpation at inferior aspect, midline hernia.Plan: to or for components release, hernia repair, abdominoplasty.¿ explant procedure: removal of previously placed hernia mesh.Repair of midline ventral hernia with bilateral sliding myofascial rectus abdominis flaps and use of retrorectus soft prolene mesh.Vertical abdominoplasty.Explant date: (b)(6) 2017.¿previous midline incision was opened after carefully marking his midline structures, and we got into the abdomen without difficulty.The incision was made from the xiphoid all the way to the symphysis pubis.After completely freeing the midline incision, we divided the old mesh in half, and his hernia was approximately 12 cm in transverse dimension by ct scan.Carefully, the mesh was dissected free from surrounding tissues and the prolenes that were holding it in place.It seemed to be a polyester type mesh.There were no bowel injuries.After excising the mesh and the posterior aspect of the abdominal wall, skin flaps were elevated for [illegible] cm off of the anterior rectus fascia for the length of the closure.There was no way to bring the muscles and soft tissues to the midline.Therefore, bilateral sliding myofascial rectus abdominis flaps were created.On the right side, through a 6 cm transverse incision, dissection down to the right semilunar line was performed.The right external oblique muscle and fascia was divided from farther above the rib cage down to the level past the anterior superior iliac spine through this transverse incision.The deep fascia of the external oblique was divided, and external oblique was mobilized off of the internal oblique.Identical procedure was performed on the left-hand side to create a left-sided myofascial rectus abdominis flap.Dissection through the 6 cm incision was made, and tissue was elevated off the semilunar lines.The left external oblique muscle and fascia was then divided to create a left-sided myofascial rectus abdominis flap.At this point, we got into the retrorectus space, though there was a scarring from the prior mesh placement, we were able to get to reasonable posterior fascia.However, superiorly, it will be difficult to get the posterior fascia completely closed.Therefore, in an inferior to superior direction, the closure was then performed.We closed a bit of the posterior fascia, and then used both mesh strips for the anterior rectus fascia, and retrorectus mesh 7.5 cm wide, with bites [illegible] cm from the medical border of the rectus muscle to help bring the rectus muscles together.Brining [sic] the anterior muscles together, brought the posterior fascia toward the midline along with it.Therefore, we essentially [illegible] up the fascia from inferior to superior, closing some posterior fascia, then closing the muscle, and then closing anterior fascia, and doing these maneuvers in this way, we got the posterior fascia completely closed.Then, the final mesh sutures were used to bring the medial border of the rectus muscles to the midline.Two drains were placed in the midline, and 1 in each of the release sites.The skin then had its abdominoplasty.After carefully undermining, we were able to excise a good amount of skin in a vertical pattern.We used pumpkin-teeth flaps to create a neoumbilicus.The skin was then closed after hemostasis achieved with 3-0 vicryl suture and a [illegible] -0 monocryl suture.¿ records indicate a non-gore device was implanted during the (b)(6) 2017 procedure.Relevant medical information: (b)(6) 2017: ¿wounds clean, without excessive erythema, non-inflamed, incisions are clean, dry, intact minimal tenderness, without erythema or swelling.¿ (b)(6) 2017: ¿post-operative day 2 after abdominoplasty with adequate pain control from thoracic epidural and pcea [patient controlled epidural analgesia].Pruritis remains issue but under control.Pain under good control.¿ (b)(6) 2017: discharge summary: ¿admitted following surgery, return bowel function, recovery from anesthesia, general surgical observation.No acute events, discharged home.F/u in office.¿ conclusion: it should be noted that the gore® synecor biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence.¿ the gore® synecor biomaterial instructions for use warns, ¿as with any mesh, use of gore® synecor biomaterial in contaminated fields may require removal of the mesh if infection occurs.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

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Brand Name

GORE SYNECOR INTRAPERITONEAL BIOMATERIAL

Type of Device

MESH, SURGICAL, POLYMERIC

Manufacturer (Section D)

W.L. GORE & ASSOCIATES

flagstaff AZ

MDR Report Key

7818985

MDR Text Key

118307272

Report Number

3003910212-2018-00075

Device Sequence Number

Product Code

FTL

Combination Product (y/n)

PMA/PMN Number

K152609

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

08/27/2018

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

04/21/2019

Device Catalogue Number

GKFR2025

Device Lot Number

15010513

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Hospitalization; Required Intervention;

Patient Weight

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE SYNECOR INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC

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