Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Pain (1994); Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).It should be noted that the gore dualmesh® plus 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, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2010, whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: additional surgery, mesh removal, abdominal pain.Additional event specific information was not provided.
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Manufacturer Narrative
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H6:codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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: records between (b)(6) 2010 and (b)(6) 2013 were not provided.Records dated (b)(6) 2013 indicate an ultrasound of the right upper quadrant was performed.Impression from the us state: ¿cholelithiasis, with chronic cholecystitis.Horseshoe kidney.Gallstones were not appreciated at the time of previous ct scanning of (b)(6) 2008.¿ history and physical records dated (b)(6) 2013indicates the patient presented for elective laparoscopic cholecystectomy with discharge on (b)(6) 2013.¿36 y.O.Female who presents for elective cholecystectomy.Presented to ed 3.6 weeks ago with ruq pain radiating to back, which quickly improved.Had a ruq us as op which demonstrated cholelithiasis and chronic cholecystitis.Has a history of laparoscopic ventral hernia repair.¿ operative records dated (b)(6) 2016 continue: ¿the deep dermis of the skin was then re-approximated with numerous, interrupted, 4-0 vicryl sutures.The skin edges were re-approximated with a single, running, 4-0 vicryl subcuticular suture, and 0.51 marcaine with epinephrine was infiltrated around the skin incision into the dermal and subcutaneous tissues.A single 1/2-inch steri-strip was applied over the skin incision site, covered by dry gauze dressings.¿ the records indicate a non-gore device was implanted during the procedure.A surgical pathology report dated (b)(6) 2016 regarding a specimen collected (b)(6) 2016 states: specimen(s) submitted: old hernia mesh.Gross description: consists of three portions of mesh with attached tan brown to tan yellow, focally cauterized fibrofatty soft tissue, 5.2 x 4.8 x 1.0cm in aggregate.On sectioning the specimen, the cut surfaces are tan white, smooth and dull.¿ ¿final diagnosis: old hernial mesh: -portion of foreign material with surrounding foreign body giant cell reaction (mesh).¿ records dated (b)(6) 2016state the patient ¿¿presents with a [prior medical history] significant for asthma, laparoscopic cholecystectomy (2013) with dr.(b)(6) ventral hernia repair with dr.(b)(6) (2007), and a more recent open repair using a simple, porous, polypropylene mesh fascia overlaying a primary midline fascia closure with dr.(b)(6) (b)(6) 2016 she no [sic] presents on (b)(6) 2016 with abdominal pain, nausea, fevers and chills.She reports that on [sic] she initially was doing well and saw dr.(b)(6) in the office for a postoperative visit on (b)(6) 2016.He removed a subcutaneous drain placed at the time of the surgery and that things were going well.¿ the (b)(6) 2016 visit records state: ¿however, on the way home she began having pain in the right lower quadrant area where the drain was pulled, but she did not seek any medical attention.A few days later ¿ on (b)(6) 2016 the abdominal pain had not subsided and she began to feel feverish, so she decided to visit centegra hospital.She reported that they admitted her into the hospital there and kept her until (b)(6) 2016 to treat her with vancomycin and zosyn iv antibiotics.She was discharged with a picc line with rocephin daily, and instructed to follow up with dr.(b)(6).A home health nurse visited her the next day and had to drain 30 cc of fluid according to the patient while changing her dressing.She saw dr.(b)(6) again in the office, accompanied by her husband, and her abdomen appeared to be improved.A 1-2 cm opening in the midline incision made by a doctor at centegra appeared to be clean with minimal discharge.The (b)(6) 2016 records continue: ¿she returned to see dr.(b)(6) today because of increased pain and fever.He sent her to the ed to get further evaluated due to a fever of 102.6 in his office.She reported abdominal pain located in the right lower quadrant, associated with nausea but no vomiting, and fevers and chills.¿ exam notes state: ¿open wound measuring approximately 1x1 cm superior to the umbilicus with minimal erythema but no purulent or malodorous drainage; abdomen soft, tender to palpation in the right lower quadrant, but no rebound or guarding appreciated.¿ an addendum to the (b)(6) 2016 records state: ¿this attending saw and re-examined the patient personally.Interestingly, she developed a fever to 102+, and appeared to be a little dehydrated, but she was not tachycardic and where abdominal wound actually appeared healthy.The wound is granulating well, has no malodorous discharge, no surrounding signs of induration or cellulitis, and there are no signs of peritoneal inflammation.Her abdomen is actually soft.She has been tolerating a normal diet and having normal bowel movements.We will obtain a ct scan to look for subcutaneous areas of the wound that may need drainage, and also fully assess her abdominal cavity.There is a possibility that the picc line may be infected as well, and may be removed.Blood cultures will be obtained and we will begin her on other antibiotics.¿ records for ct scan of the abdomen and pelvis dated (b)(6) 2016 state: ¿indication: right lower quadrant abdominal pain.History of recent hernia surgery.¿ ¿there is a midline anterior abdominal wall wound healing by secondary intent, small left adrenal adenoma.Foot appears to be surgical mesh is noted at the base of the wound consistent with the history of hernia repair.There is soft tissue thickening of the muscle layer.A few small bubbles of gas are also noted at the muscle layer/subcutaneous junction.These may be related to the open abdominal wound.¿ progress notes dated (b)(6) 2016 state: ¿she appears to be doing better, has no fever, and is maintaining stable vital signs.She does not appear to be septic.She reports almost no pain and is tolerating her breakfast.Interestingly, she has no leukocytosis and no left shift.Her abdomen is quite benign on exam, and her abdominal wall can be moved easily with palpation, generating no pain or tenderness.The small wound is pink, clean, with no significant discharge.The ct scan does not show fluid collections that need drainage, and overall appears to show normal postoperative changes.¿ discharge note dated (b)(6) 2016 states: ¿patient presented febrile with an open wound and recent history of surgery, was admitted for infectious work up and treated with iv vanc and zosyn, discharged next day without any new fevers, chills, or abdominal pain.¿ discharge diagnosis states: ¿abdominal pain and wound infection with gram negative rods and gram positive cocci in pairs.¿ 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 dualmesh® plus 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, and 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.
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Manufacturer Narrative
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B7: added medical history.H6:codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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: records prior to (b)(6) 2010 including records for umbilical and periumbilical laparoscopic hernia repair and partial removal of uterine cervix in 2006 were not provided.Operative records (b)(6) 2010 indicate the patient underwent single incision laparoscopic repair of ventral hernia, using a dual plus gore-tex mesh, a 15x 19 cm (trimmed to 10 x 12 cm).This is a ¿33-year-old lady who presented to me with symptomatic upper ventrai hernia.¿ the operative records dated (b)(6) 2010 state: ¿we entered the abdomen through a 1.5 cm incision in the left upper lateral subcostal area, inserting the triport port under direct vision and the abdomen was insufflated to 15 mmhg, which the patient tolerated well.We then used the reticulating 5 mm laparoscope called endoscope.Diagnostic laparoscopy was made and there was no evidence of umbilical hernia, but there was, a few centimeters above the umbilicus, evidence of ventral hernia which appeared to have multiple small defects, although the patient did not have any prior incisions on her fascia.¿ the records dated (b)(6) 2010 continue: ¿we measured the hernia defect out 5 x 5 cm.I chose the mesh, 15 x 19 cm, dual-plus gore-tex mesh and trimmed it to about 10 x 12 cm.This was sutured on the four apices of the mesh with cv-0 gore-tex after the proper orientation was identified, as far as the rough surface toward the abdominal wall, as well as the orientation in the abdomen, as far as the right and left.The mesh was then rolled and placed into the abdomen after the cap of the tri port was removed.We then unrolled the mesh using the curved olympus instruments.¿ the operative records dated (b)(6) 2010state: ¿using the carter-thompson needle, we then grabbed the gore-tex suture at the four different placed.Of note, we made stab incisions in each one of the four areas and each string was pulled through the fascia, leaving about 1cm bridge between the two holes in the fascia while coming out through the same hole in the skin.¿ the records dated (b)(6) 2010continue: ¿these were tied down to the fascia without being too tight, to prevent pain.The skin was released.The mesh appeared to lay nicely and had appropriate amount of tension.We them used the covidien tacker device and put tacks all around the circumference of the mesh, not leaving more than 1.5cm between the tacks to prevent slippage of small bowel viscera.¿ the (b)(6) 2010records state: ¿the mesh appeared to be under appropriate tension, protected on all edges.The gas was emptied, trocar was pulled out and the fascia was closed with figure-of-eight 0 vicryl on a ur-6 needle and the skin was closed using running subcuticular 4-0 monocryl.¿ device identification records for the gore dualmesh® plus biomaterial were not provided.Records between (b)(6) 2010 and (b)(6) 2013 were not provided.History and physical records dated(b)(6) 2013 indicates the patient presented for elective laparoscopic cholecystectomy with discharged on (b)(6) 2013 the operative records dated (b)(6) 2013 state: ¿because of the patient¿s previous surgery, a 10mm port was placed in the left upper quadrant in the subcostal region anterolaterally, and a telescope and camera were inserted for visualization of the abdomen.Numerous dense adhesions were seen, primarily involving the omentum up towards the anterior abdominal wall where a large mesh had been previously placed and tacked to the undersurface to peritoneum.¿ the records dated (b)(6) 2013 continue: ¿using curved scissor dissection, the adhesions were carefully taken down off of the peritoneal surface, almost in their entirety freeing up the per-umbilical tissues of the abdominal wall.A 1 x 3 cm defect of the hernia sac was seen along the upper portion of the mesh.No bowel or viscera were within this opening.¿ the operative records dated (b)(6) 2013 state: ¿a 5mm port was then placed superiorly and laterally to the mesh near the umbilicus using sharp trocar technique.Visualization from within demonstrated no visceral injuries.A 30-degree angled telescope attached to the camera was then passed through this 5mm port and visualization of the gallbladder, which appeared whitish thickened.¿ records dated (b)(6) 2013 continue: ¿the gallbladder was able to be retracted adequately.¿ ¿dissection continued using endo-dissectors through the right upper quadrant abdominal port site.The anatomy appeared to be somewhat unusual and it was felt that after several dense adhesive tissues were taken down, the right cystic artery was identified.¿ operative records dated (b)(6) 2013 state: ¿the gallbladder was carefully dissected free from the subhepatic space.¿ ¿once the gallbladder was completely freed up, the subhepatic space was irrigated and inspected and hemostasis was found to be excellent.The gallbladder was placed in a gallbladder bag and delivered out through the left upper quadrant port site.¿ emergency department records dated (b)(6) 2014 indicate patient was seen for wound check (abdominal wound drainage and packing).Records dated between (b)(6) 2014 and (b)(6) 2016 were not provided.Operative records dated (b)(6) 2016indicates the patient underwent open ventral herniorrhaphy with mesh placement.The patient ¿¿is a 39-year-old woman who was initially seen by this attending in the office on (b)(6) 2016.She presented with recurrent epigastric abdominal pain associated with stomach cramps.Approximately seven years ago, she had a ventral hernia repaired laparoscopically by dr.(b)(6) at (b)(6) hospital.Prior surgery also included a laparoscopic cholecystectomy approximately five years ago.¿ operative records dated (b)(6) 2016 state: ¿physical exam demonstrated a large ventral hernia located superior to the umbilicus along the abdominal midline.The hernia contained bowel and fatty tissue, which were easily reducible.¿ the (b)(6) 2016 records continue: ¿a vertical midline abdominal incision was made above the umbilicus approximately five cm in length with a #15 scalpel.Dissection continued down through the subcutaneous tissue with electrocautery.A hernia sac was readily encountered in the subcutaneous tissue, and using mixture-guided electrocautery, the sac was freed up down towards the level of the fascia circumferentially.¿ the operative records dated (b)(6) 2016 state: ¿a large defect, approximately six to seven cm was noted.Several smaller defects were noted inferior to the level of the primary fascial defect as well.There was "crumpled up" mesh overlying the herniated tissues, and numerous, coiled, steel tacks as well.The mesh, which was separated from the fascia, was further dissected as far as possible circumferentially.It was then excised from omentum with cautery dissection and removed from the operative field.A.Couple of bleeding points on the omentum were tied with 3-0 vicryl suture ligatures.¿ the records dated (b)(6) 2016 state: ¿once the mesh was removed, the fascial edges joining all of the defects along the midline in the epigastrium were freed up along the rectus abdominis muscles bilaterally.Once healthy fascial edges were completely identified, the subcutaneous tissues were dissected free from the fascia of the anterior rectus sheath for several centimeters on each side of the midline.No injury to bowel or other abdominal viscera was noted.¿ records dated (b)(6) 2016 continue: ¿the midline fascia was then reapproximated to itself along the midline closing the hernia defect with numerous interrupted 0-pds figure-of-eight sutures.The fascial closure appeared to be healthy, strong and intact.The subcutaneous tissues were further raised off of the anterior rectus sheath for several centimeters on each side of the midline repair, along with extensions in both the caudad and cephalad directions.¿ operative records dated (b)(6) 2016 state: ¿a simple polypropylene mesh was then cut in an oval fashion, with the maximum diameters of approximately 10 x 12 cm.The mesh was then sutured to the anterior rectus sheath fascia over the primary suture line of closure, extending for several cm on each side, as well as in the caudad and cephalad directions.Numerous interrupted 3-0 vicryl sutures were used.Additional 3-0 vicryl sutures were used to tack the mesh to the primary suture line of closure along the midline, as well as along several points in the body of the mesh on each side of the midline.Once the mesh was secured in place, the wound was irrigated with copious amounts of warm saline solution.Inspection demonstrated no bleeding or other abnormalities.¿ records dated (b)(6) 2016continue: ¿a medium-large, flat jp drain was then placed external to the mesh and fascia in the subcutaneous tissue, and was brought out through a separate stab wound in the right lateral abdominal wall.The drain was cut appropriate dimensions and sutured to the skin at the exit site with a single 3-0 nylon basket-weave type suture.¿ operative records dated (b)(6) 2016 continue: ¿the deep dermis of the skin was then re-approximated with numerous, interrupted, 4-0 vicryl sutures.The skin edges were re-approximated with a single, running, 4-0 vicryl subcuticular suture, and 0.51 marcaine with epinephrine was infiltrated around the skin incision into the dermal and subcutaneous tissues.A single 1/2-inch steri-strip was applied over the skin incision site, covered by dry gauze dressings.¿ operative records (b)(6) 2016 indicate specimen a-old hernia mesh.Consists of three portions of mesh with attached tan brown to tan yellow, focally cauterized fibrofatty soft tissue, 5.2 x 4.8 x 1.0cm in aggregate.On sectioning the specimen, the cut surfaces are tan white, smooth and dull.The specimen is serially sectioned and representative sections are submitted in a1.Final diagnosis-portion of foreign material with surrounding foreign body giant cell reaction (mesh).Patient discharge records dated (b)(6) 2016 indicate the patient was admitted for acute fever, postsurgical seroma and cellulitis abdominal wall.Records indicate patient was discharged on home intravenous antibiotics for diagnosis of probable intraabdominal mesh infection.Records indicate blood culture, wound culture and ct abdomen/pelvis were performed.Records for ct scan abdomen and pelvis dated (b)(6) 2016state: ¿midline anterior abdominal wall wound healing by secondary intent, small left adrenal adenoma.Surgical consult note dated (b)(6) 2016 states: ¿chief complaint-abdominal pain, nausea, fever and chills.¿ attending surgeon addendum states: ¿the wound is granulating well, has no malodorous discharge, no surrounding signs of induration or cellulitis, and there are no signs of peritoneal inflammation.¿ wound culture and gram stain results dated (b)(6) 2016 state: ¿gram stain-rare, polymorphonuclear leukocytes observed, rare gram negative rods, rare gram positive cocci in pairs, culture report pending.¿ discharge note dated (b)(6) 2016 states: ¿patient presented febrile with an open wound and recent history of surgery, was admitted for infectious work up and treated with iv vanc and zosyn, discharged next day without any new fevers, chills, or abdominal pain.¿ 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 dualmesh® plus 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, and 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.
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Manufacturer Narrative
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Updated patient codes; updated device code; updated conclusion codes; conclusion code 4316: appropriate term/code available for ¿withdrawn complaint¿.Previous patient code (1994) was reported, based on the original complaint.And are no longer applicable per gore¿s investigation.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.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2016.And not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Medical records from (b)(6) 2010 through (b)(6) 2013; from (b)(6) 2014 through (b)(6) 2016 were not provided.Patient information: medical history: asthma, hypothyroidism, heliobacter pylori infection.Prior surgical procedures: 2006, umbilical and periumbilical laparoscopic hernia repair; 2006, partial removal of uterine cervix.Implant preoperative complaints: (b)(6) 2010, [the patient] ¿33-year-old lady who presented to me with symptomatic upper ventral hernia¿.Implant procedure: single incision laparoscopic repair of ventral hernia, using a ¿dual plus gore-tex mesh, a 15x 19 cm (trimmed to 10 x 12 cm)¿, implant: gore® dualmesh® plus biomaterial (unk/unk).Implant date: date (b)(6) 2010.Description of hernia being treated: ¿diagnostic laparoscopy was made and there was no evidence of umbilical hernia, but there was, a few centimeters above the umbilicus.Evidence of ventral hernia.Which appeared to have multiple small defects.Although, the patient did not have any prior incisions on her fascia¿.Implant size and fixation: ¿we measured the hernia defect out 5 x 5 cm.I chose the mesh 15 x 19 cm, dual-plus gore-tex mesh.And trimmed it to about 10 x 12 cm.This was sutured on the four apices of the mesh with cv-0 gore-tex, after the proper orientation was identified.As far as the rough surface toward the abdominal wall, as well as the orientation in the abdomen, as far as the right and left.The mesh was then rolled and placed into the abdomen, after the cap of the tri port was removed.We then unrolled the mesh using the curved olympus instruments.Using the carter-thompson [carter-thomason] needle, we then grabbed the gore-tex suture at the four different placed.Of note, we made stab incisions in each one of the four areas.And each string was pulled through the fascia, leaving about 1cm bridge between the two holes in the fascia.While coming out through the same hole in the skin.These were tied down to the fascia without being too tight, to prevent pain.The skin was released.The mesh appeared to lay nicely.And had appropriate amount of tension.We then [sic] used the covidien tacker device and put tacks all around the circumference of the mesh, not leaving more than 1.5cm between the tacks to prevent slippage of small bowel viscera.The mesh appeared to be under appropriate tension, protected on all edges.The gas was emptied, trocar was pulled out and the fascia was closed with figure-of-eight 0 vicryl on a ur-6 needle.And the skin was closed using running subcuticular 4-0 monocryl¿.No post-operative records were provided.Relevant medical information: (b)(6) 2013, ultrasound of right upper quadrant: ¿cholelithiasis, with chronic cholecystitis, horseshoe kidney, gallstones were not appreciated at the time of previous ct scanning of (b)(6) 2008¿.(b)(6) 2013, elective laparoscopic cholecystectomy [hospitalized (b)(6) 2013]. ¿36 y.O.[year old] female who presents for elective cholecystectomy.Presented to ed [emergency department] (b)(6) weeks ago with ruq [right upper quadrant] pain radiating to back.Which quickly improved.Had a ruq us [ultrasound] as op [out-patient].Which demonstrated, cholelithiasis and chronic cholecystitis.Has a history of laparoscopic ventral hernia repair¿. ¿because of the patient¿s previous surgery, a 10mm port was placed in the left upper quadrant in the subcostal region anterolaterally.And a telescope and camera were inserted for visualization of the abdomen.Numerous dense adhesions were seen, primarily involving the omentum up towards the anterior abdominal wall.Where a large mesh had been previously, placed and tacked to the undersurface to peritoneum¿.¿using curved scissor dissection, the adhesions were carefully taken down off of the peritoneal surface.Almost in their entirety freeing up the per-umbilical tissues of the abdominal wall.A 1 x 3 cm defect of the hernia sac was seen along the upper portion of the mesh.No bowel or viscera were within this opening¿.¿a 5mm port was then placed superiorly and laterally to the mesh near the umbilicus using sharp trocar technique.Visualization from within demonstrated no visceral injuries.A 30-degree angled telescope attached to the camera was then passed through this 5mm port and visualization of the gallbladder.Which appeared whitish thickened¿.¿the gallbladder was able to be retracted adequately¿.¿dissection continued using endo-dissectors through the right upper quadrant abdominal port site.The anatomy appeared to be somewhat unusual.And it was felt that after several dense adhesive tissues were taken down.The right cystic artery was identified¿.¿the gallbladder was carefully dissected free from the subhepatic space¿.¿once the gallbladder was completely freed up, the subhepatic space was irrigated and inspected.And hemostasis was found to be excellent.The gallbladder was placed in a gallbladder bag and delivered out through the left upper quadrant port site¿.(b)(6) 2014, emergency department records, indicate the patient was seen for a ¿wound check (abdominal wound drainage and packing)¿.Explant preoperative complaints: (b)(6) 2016, [the patient] ¿is a 39-year-old woman who was initially seen by this attending in the office on (b)(6) 2016.She presented with recurrent epigastric abdominal pain associated with stomach cramps¿.¿physical exam demonstrated a large ventral hernia located superior to the umbilicus along the abdominal midline.The hernia contained bowel and fatty tissue, which were easily reducible¿.Explant procedure: open ventral herniorrhaphy with mesh placement.Explant date: (b)(6) 2016.¿a vertical midline abdominal incision was made above the umbilicus approximately five cm in length with a #15 scalpel.Dissection continued down through the subcutaneous tissue with electrocautery.A hernia sac was readily encountered in the subcutaneous tissue.And using mixture-guided electrocautery, the sac was freed up down towards the level of the fascia circumferentially.A large defect, approximately six to seven cm was noted.Several smaller defects were noted, inferior to the level of the primary fascial defect as well.There was ¿crumpled up¿ mesh overlying the herniated tissues, and numerous, coiled, steel tacks as well.The mesh, which was separated from the fascia, was further dissected as far as possible circumferentially.It was then excised, from omentum with cautery dissection and removed from the operative field.A.Couple of bleeding points on the omentum were tied with 3-0 vicryl suture ligatures.Once the mesh was removed, the fascial edges joining all of the defects along the midline in the epigastrium were freed up along the rectus abdominis muscles bilaterally.Once healthy fascial edges were completely identified, the subcutaneous tissues were dissected free from the fascia of the anterior rectus sheath for several centimeters on each side of the midline.No injury to bowel or other abdominal viscera was noted.The midline fascia was then reapproximated to itself along the midline closing the hernia defect with numerous interrupted 0-pds figure-of-eight sutures.The fascial closure appeared to be healthy, strong and intact.The subcutaneous tissues were further raised off of the anterior rectus sheath for several centimeters on each side of the midline repair, along with extensions in both the caudad and cephalad directions.A simple polypropylene mesh was then cut in an oval fashion, with the maximum diameters of approximately 10 x 12 cm.The mesh was then sutured to the anterior rectus sheath fascia over the primary suture line of closure, extending for several cm on each side, as well as in the caudad and cephalad directions.Numerous interrupted 3-0 vicryl sutures were used.Additional 3-0 vicryl sutures were used to tack the mesh to the primary suture line of closure along the midline, as well as along several points in the body of the mesh on each side of the midline.Once the mesh was secured in place, the wound was irrigated with copious amounts of warm saline solution.Inspection demonstrated no bleeding or other abnormalities¿.Records indicate, a non-gore device was implanted during the (b)(6) 2016 procedure.Relevant medical information: (b)(6) 2016, pathology: consists of three portions of mesh with attached tan brown to tan yellow, focally cauterized fibrofatty soft tissue, 5.2 x 4.8 x 1.0cm in aggregate.On sectioning the specimen, the cut surfaces are tan white, smooth and dull.¿final diagnosis: old hernial mesh, portion of foreign material with surrounding foreign body giant cell reaction (mesh)¿.Conclusions: it should be noted, that the gore® dualmesh® plus biomaterial instructions for use include 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¿.Medical records that indicate, mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include, but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur, but may be referred to as a recurrent hernia.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.Section c1: name: plus antimicrobial product coating, manufacturer/compounder: w.L.Gore & associates, inc., lot number: unk.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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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Manufacturer Narrative
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H6: conclusion code 4316: appropriate term/code available for ¿withdrawn complaint.¿ previous patient code (1994) was reported based on the original complaint and are no longer applicable per gore¿s investigation.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.Medical records: the known medical records span (b)(6) 2010 through (b)(6) 2016 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Medical records from (b)(6) 2010 through (b)(6) 2013; from (b)(6) 2014 through (b)(6) 2016 were not provided.Patient information: medical history: asthma, hypothyroidism, heliobacter pylori infection.Prior surgical procedures: 2006: umbilical and periumbilical laparoscopic hernia repair, 2006: partial removal of uterine cervix.Implant preoperative complaints: on (b)(6) 2010: [the patient] ¿.33-year-old lady who presented to me with symptomatic upper ventral hernia.¿ implant procedure: single incision laparoscopic repair of ventral hernia, using a ¿dual plus gore-tex mesh, a 15x 19 cm (trimmed to 10 x 12 cm).¿ implant: gore® dualmesh® plus biomaterial (unk/unk).Implant date: date (b)(6) 2010 description of hernia being treated: ¿diagnostic laparoscopy was made and there was no evidence of umbilical hernia, but there was, a few centimeters above the umbilicus, evidence of ventral hernia which appeared to have multiple small defects, although the patient did not have any prior incisions on her fascia.¿ implant size and fixation: ¿we measured the hernia defect out 5 x 5 cm.I chose the mesh, 15 x 19 cm, dual-plus gore-tex mesh and trimmed it to about 10 x 12 cm.This was sutured on the four apices of the mesh with cv-0 gore-tex after the proper orientation was identified, as far as the rough surface toward the abdominal wall, as well as the orientation in the abdomen, as far as the right and left.The mesh was then rolled and placed into the abdomen after the cap of the tri port was removed.We then unrolled the mesh using the curved olympus instruments.Using the carter-thompson [carter-thomason] needle, we then grabbed the gore-tex suture at the four different placed.Of note, we made stab incisions in each one of the four areas and each string was pulled through the fascia, leaving about 1cm bridge between the two holes in the fascia while coming out through the same hole in the skin.These were tied down to the fascia without being too tight, to prevent pain.The skin was released.The mesh appeared to lay nicely and had appropriate amount of tension.We them [sic] used the covidien tacker device and put tacks all around the circumference of the mesh, not leaving more than 1.5cm between the tacks to prevent slippage of small bowel viscera.The mesh appeared to be under appropriate tension, protected on all edges.The gas was emptied, trocar was pulled out and the fascia was closed with figure-of-eight 0 vicryl on a ur-6 needle and the skin was closed using running subcuticular 4-0 monocryl.¿ no post-operative records were provided.Relevant medical information: on (b)(6) 2013: ultrasound of right upper quadrant: ¿cholelithiasis, with chronic cholecystitis.Horseshoe kidney.Gallstones were not appreciated at the time of previous ct scanning of (b)(6) 2008.¿ on (b)(6) 2013: elective laparoscopic cholecystectomy [hospitalized (b)(6) 2013] ¿36 y.O.[year old] female who presents for elective cholecystectomy.Presented to ed [emergency department] 3.6 weeks ago with ruq [right upper quadrant] pain radiating to back, which quickly improved.Had a ruq us [ultrasound] as op [out-patient] which demonstrated cholelithiasis and chronic cholecystitis.Has a history of laparoscopic ventral hernia repair.¿ ¿¿because of the patient¿s previous surgery, a 10mm port was placed in the left upper quadrant in the subcostal region anterolaterally, and a telescope and camera were inserted for visualization of the abdomen.Numerous dense adhesions were seen, primarily involving the omentum up towards the anterior abdominal wall where a large mesh had been previously placed and tacked to the undersurface to peritoneum.¿ ¿¿using curved scissor dissection, the adhesions were carefully taken down off of the peritoneal surface, almost in their entirety freeing up the per-umbilical tissues of the abdominal wall.A 1 x 3 cm defect of the hernia sac was seen along the upper portion of the mesh.No bowel or viscera were within this opening.¿ ¿a 5mm port was then placed superiorly and laterally to the mesh near the umbilicus using sharp trocar technique.Visualization from within demonstrated no visceral injuries.A 30-degree angled telescope attached to the camera was then passed through this 5mm port and visualization of the gallbladder, which appeared whitish thickened.¿ ¿¿the gallbladder was able to be retracted adequately.¿ ¿dissection continued using endo-dissectors through the right upper quadrant abdominal port site.The anatomy appeared to be somewhat unusual and it was felt that after several dense adhesive tissues were taken down, the right cystic artery was identified.¿ ¿¿the gallbladder was carefully dissected free from the subhepatic space.¿ ¿once the gallbladder was completely freed up, the subhepatic space was irrigated and inspected and hemostasis was found to be excellent.The gallbladder was placed in a gallbladder bag and delivered out through the left upper quadrant port site.¿ on (b)(6) 2014: emergency department records indicate the patient was seen for a ¿wound check (abdominal wound drainage and packing).¿ explant preoperative complaints: on (b)(6) 2016: [the patient] ¿.Is a 39-year-old woman who was initially seen by this attending in the office on (b)(6) 2016.She presented with recurrent epigastric abdominal pain associated with stomach cramps.¿ ¿physical exam demonstrated a large ventral hernia located superior to the umbilicus along the abdominal midline.The hernia contained bowel and fatty tissue, which were easily reducible.¿ explant procedure: open ventral herniorrhaphy with mesh placement.Explant date: (b)(6) 2016.¿a vertical midline abdominal incision was made above the umbilicus approximately five cm in length with a #15 scalpel.Dissection continued down through the subcutaneous tissue with electrocautery.A hernia sac was readily encountered in the subcutaneous tissue, and using mixture-guided electrocautery, the sac was freed up down towards the level of the fascia circumferentially.A large defect, approximately six to seven cm was noted.Several smaller defects were noted inferior to the level of the primary fascial defect as well.There was ¿crumpled up¿ mesh overlying the herniated tissues , and numerous, coiled, steel tacks as well.The mesh, which was separated from the fascia, was further dissected as far as possible circumferentially.It was then excised from omentum with cautery dissection and removed from the operative field.A.Couple of bleeding points on the omentum were tied with 3-0 vicryl suture ligatures.Once the mesh was removed , the fascial edges joining all of the defects along the midline in the epigastrium were freed up along the rectus abdominis muscles bilaterally.Once healthy fascial edges were completely identified, the subcutaneous tissues were dissected free from the fascia of the anterior rectus sheath for several centimeters on each side of the midline.No injury to bowel or other abdominal viscera was noted.The midline fascia was then reapproximated to itself along the midline closing the hernia defect with numerous interrupted 0-pds figure-of-eight sutures.The fascial closure appeared to be healthy, strong and intact.The subcutaneous tissues were further raised off of the anterior rectus sheath for several centimeters on each side of the midline repair, along with extensions in both the caudad and cephalad directions.A simple polypropylene mesh was then cut in an oval fashion, with the maximum diameters of approximately 10 x 12 cm.The mesh was then sutured to the anterior rectus sheath fascia over the primary suture line of closure, extending for several cm on each side, as well as in the caudad and cephalad directions.Numerous interrupted 3-0 vicryl sutures were used.Additional 3-0 vicryl sutures were used to tack the mesh to the primary suture line of closure along the midline, as well as along several points in the body of the mesh on each side of the midline.Once the mesh was secured in place, the wound was irrigated with copious amounts of warm saline solution.Inspection demonstrated no bleeding or other abnormalities.¿ records indicate a non-gore device was implanted during the 11/28/2016 procedure.Relevant medical information: on (b)(6) 2016: pathology: consists of three portions of mesh with attached tan brown to tan yellow, focally cauterized fibrofatty soft tissue, 5.2 x 4.8 x 1.0cm in aggregate.On sectioning the specimen, the cut surfaces are tan white, smooth and dull.¿ ¿final diagnosis: old hernial mesh: -portion of foreign material with surrounding foreign body giant cell reaction (mesh).¿ conclusions: it should be noted that the gore® dualmesh® plus biomaterial instructions for use include 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: unk.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].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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Manufacturer Narrative
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H6: updated health effect - clinical code.H6: updated investigation conclusions.H6: health effect impact code: f26: no health consequences or impact.H6: d17: appropriate term/code not available for "withdrawn complaint" previous patient code (1994) was reported based on the original complaint and are no longer applicable per gore¿s investigation.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.Medical records: the known medical records span (b)(6), 2010 through (b)(6), 2016 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Medical records from (b)(6) 2010 through (b)(6) 2013; from (b)(6) 2014 through (b)(6), 2016 were not provided.Patient information: medical history: asthma, hypothyroidism , heliobacter pylori infection, prior surgical procedures: 2006: umbilical and periumbilical laparoscopic hernia repair.2006: partial removal of uterine cervix.Implant preoperative complaints: (b)(6) 2010: [the patient] ¿.33-year-old lady who presented to me with symptomatic upper ventral hernia.¿ implant procedure: single incision laparoscopic repair of ventral hernia, using a ¿dual plus gore-tex mesh, a 15x 19 cm (trimmed to 10 x 12 cm).¿ implant: gore® dualmesh® plus biomaterial (unk/unk).Implant date: date (b)(6) 2010 description of hernia being treated: ¿diagnostic laparoscopy was made and there was no evidence of umbilical hernia, but there was, a few centimeters above the umbilicus, evidence of ventral hernia which appeared to have multiple small defects, although the patient did not have any prior incisions on her fascia.¿ implant size and fixation: ¿we measured the hernia defect out 5 x 5 cm.I chose the mesh, 15 x 19 cm, dual-plus gore-tex mesh and trimmed it to about 10 x 12 cm.This was sutured on the four apices of the mesh with cv-0 gore-tex after the proper orientation was identified, as far as the rough surface toward the abdominal wall, as well as the orientation in the abdomen, as far as the right and left.The mesh was then rolled and placed into the abdomen after the cap of the tri port was removed.We then unrolled the mesh using the curved olympus instruments.Using the carter-thompson [carter-thomason] needle, we then grabbed the gore-tex suture at the four different placed.Of note, we made stab incisions in each one of the four areas and each string was pulled through the fascia, leaving about 1cm bridge between the two holes in the fascia while coming out through the same hole in the skin.These were tied down to the fascia without being too tight, to prevent pain.The skin was released.The mesh appeared to lay nicely and had appropriate amount of tension.We them [sic] used the covidien tacker device and put tacks all around the circumference of the mesh, not leaving more than 1.5cm between the tacks to prevent slippage of small bowel viscera.The mesh appeared to be under appropriate tension, protected on all edges.The gas was emptied, trocar was pulled out and the fascia was closed with figure-of-eight 0 vicryl on a ur-6 needle and the skin was closed using running subcuticular 4-0 monocryl.¿ no post-operative records were provided.Relevant medical information: (b)(6) 2013: ultrasound of right upper quadrant: ¿cholelithiasis, with chronic cholecystitis.Horseshoe kidney.Gallstones were not appreciated at the time of previous ct scanning of (b)(6) 2008.¿ (b)(6) 2013: elective laparoscopic cholecystectomy [hospitalized april 17 ¿ 18, 2013] ¿36 y.O.[year old] female who presents for elective cholecystectomy.Presented to ed [emergency department] 3.6 weeks ago with ruq [right upper quadrant] pain radiating to back, which quickly improved.Had a ruq us [ultrasound] as op [out-patient] which demonstrated cholelithiasis and chronic cholecystitis.Has a history of laparoscopic ventral hernia repair.¿ ¿¿because of the patient¿s previous surgery, a 10mm port was placed in the left upper quadrant in the subcostal region anterolaterally, and a telescope and camera were inserted for visualization of the abdomen.Numerous dense adhesions were seen, primarily involving the omentum up towards the anterior abdominal wall where a large mesh had been previously placed and tacked to the undersurface to peritoneum.¿ ¿¿using curved scissor dissection, the adhesions were carefully taken down off of the peritoneal surface, almost in their entirety freeing up the per-umbilical tissues of the abdominal wall.A 1 x 3 cm defect of the hernia sac was seen along the upper portion of the mesh.No bowel or viscera were within this opening.¿ ¿a 5mm port was then placed superiorly and laterally to the mesh near the umbilicus using sharp trocar technique.Visualization from within demonstrated no visceral injuries.A 30-degree angled telescope attached to the camera was then passed through this 5mm port and visualization of the gallbladder, which appeared whitish thickened.¿ ¿¿the gallbladder was able to be retracted adequately.¿ ¿dissection continued using endo-dissectors through the right upper quadrant abdominal port site.The anatomy appeared to be somewhat unusual and it was felt that after several dense adhesive tissues were taken down, the right cystic artery was identified.¿ ¿¿the gallbladder was carefully dissected free from the subhepatic space.¿ ¿once the gallbladder was completely freed up, the subhepatic space was irrigated and inspected and hemostasis was found to be excellent.The gallbladder was placed in a gallbladder bag and delivered out through the left upper quadrant port site.¿ (b)(6) 2014: emergency department records indicate the patient was seen for a ¿wound check (abdominal wound drainage and packing).¿ explant preoperative complaints: (b)(6) 2016: [the patient] ¿.Is a 39-year-old woman who was initially seen by this attending in the office on (b)(6) 2016.She presented with recurrent epigastric abdominal pain associated with stomach cramps.¿ ¿physical exam demonstrated a large ventral hernia located superior to the umbilicus along the abdominal midline.The hernia contained bowel and fatty tissue, which were easily reducible.¿ explant procedure: open ventral herniorrhaphy with mesh placement explant date: (b)(6), 2016 ¿a vertical midline abdominal incision was made above the umbilicus approximately five cm in length with a #15 scalpel.Dissection continued down through the subcutaneous tissue with electrocautery.A hernia sac was readily encountered in the subcutaneous tissue, and using mixture-guided electrocautery, the sac was freed up down towards the level of the fascia circumferentially.A large defect, approximately six to seven cm was noted.Several smaller defects were noted inferior to the level of the primary fascial defect as well.There was ¿crumpled up¿ mesh overlying the herniated tissues , and numerous, coiled, steel tacks as well.The mesh, which was separated from the fascia, was further dissected as far as possible circumferentially.It was then excised from omentum with cautery dissection and removed from the operative field.A.Couple of bleeding points on the omentum were tied with 3-0 vicryl suture ligatures.Once the mesh was removed , the fascial edges joining all of the defects along the midline in the epigastrium were freed up along the rectus abdominis muscles bilaterally.Once healthy fascial edges were completely identified, the subcutaneous tissues were dissected free from the fascia of the anterior rectus sheath for several centimeters on each side of the midline.No injury to bowel or other abdominal viscera was noted.The midline fascia was then reapproximated to itself along the midline closing the hernia defect with numerous interrupted 0-pds figure-of-eight sutures.The fascial closure appeared to be healthy, strong and intact.The subcutaneous tissues were further raised off of the anterior rectus sheath for several centimeters on each side of the midline repair, along with extensions in both the caudad and cephalad directions.A simple polypropylene mesh was then cut in an oval fashion, with the maximum diameters of approximately 10 x 12 cm.The mesh was then sutured to the anterior rectus sheath fascia over the primary suture line of closure, extending for several cm on each side, as well as in the caudad and cephalad directions.Numerous interrupted 3-0 vicryl sutures were used.Additional 3-0 vicryl sutures were used to tack the mesh to the primary suture line of closure along the midline, as well as along several points in the body of the mesh on each side of the midline.Once the mesh was secured in place, the wound was irrigated with copious amounts of warm saline solution.Inspection demonstrated no bleeding or other abnormalities.¿ records indicate a non-gore device was implanted during the 11/28/16 procedure.Relevant medical information: (b)(6) 2016: pathology: consists of three portions of mesh with attached tan brown to tan yellow, focally cauterized fibrofatty soft tissue, 5.2 x 4.8 x 1.0cm in aggregate.On sectioning the specimen, the cut surfaces are tan white, smooth and dull.¿ ¿final diagnosis: old hernial mesh: -portion of foreign material with surrounding foreign body giant cell reaction (mesh).¿ conclusions it should be noted that the gore® dualmesh® plus biomaterial instructions for use include 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.After multiple requests, specific lot number information was not provided for this device but product type was confirmed through other records provided.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.Although a review of manufacturing and sterilization records could not be performed, all pre-release specifications are confirmed prior to release as part of quality system processes.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: unk additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].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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