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Model Number 1DLMC03 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Granuloma (1876); Unspecified Infection (1930); Seroma (2069)
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Event Date 12/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).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) 2009, including records for the ¿open paraomental hernia repair with mesh (b)(6) 2009¿ and ¿history of skin graft in 2009 with multiple wound debridements and skin grafts to a sternal wound¿ noted in the medical records, were not provided.Operative records dated (b)(6) 2009 state the patient underwent laparoscopic recurrent ventral hernia repair with mesh implantation.Indications for the procedure state: ¿the patient is a lady with history of cabg with wound infection status post skin graft as part of her operative repair.She subsequently developed the ventral hernia and underwent a ventral hernia repair back in early part of this year.Since then, she has complained of recurrent ventral hernia enlargement.She was seen in the clinic and decided to have this recurrent hernia repaired.¿ postoperative finding states: ¿large subxiphoid ventral hernia with small bowel and omental involvement.¿ product identification and operative records for the prior ¿laparoscopic recurrent ventral hernia repair with mesh implantation¿ were not provided.The (b)(6) 2009 operative report states: ¿incision was made in the right abdominal wall lateral to the midclavicular line.Dissection was carried down bluntly through subcutaneous tissue until the fascia was reached and sharply incised into and a balloon trocar was inserted.¿ ¿at this point, we identified a large subxiphoid ventral hernia with involvement of the small bowel and omentum.Using endoshears, we proceeded to take down the adhesions.Following extensive lysis of adhesions, the small bowel was dissected free.At this point, the omentum that was trapped in the ventral hernia was inspected.Due to her prior skin graft, it was decided that the omentum would be left in place to provide blood flow to the skin graft.Inspection of the omentum, we were able to identify 2 large vessels supplying this portion of the omentum and preserved this vasculature.¿ the (b)(6) 2009 operative report continues: ¿at this point, with the lysis of adhesions complete, we proceeded to place a dualmesh plus of 34 x 26 in size for our hernia repair.First, the mesh was prepared with gore sutures and was introduced into the abdomen.Once this was accomplished, it was unrolled intraabdominally and anchored to the abdominal wall in the superior, inferior, and in bilateral positions with the use of a carter-thomason suture-passing device.Once the mesh was anchored in these positions, a series of anchors placed with the protacker was placed along the border of the mesh.Additional anchor sutures were placed with gore sutures in between the previously placed anchor sutures.Once all of these were completed, final inspection demonstrated no evidence of active bleeding or evidence of bowel injury.At this point, the abdomen was desufflated.Using o vicryl stitches, the balloon trocar port site was reapproximated.The fascia for the balloon trocar port site was reapproximated using a series of figure-of-eight stitches.The skin was reapproximated at all port incisions with 4-0 monocryl subcuticular stitches.Additionally, the stab wounds required for the placement of our anchor sutures were reapproximated.¿ the records confirm a gore dualmesh® plus biomaterial with holes (1dlmcph08/05803916) was implanted during the procedure.Records dated (b)(6) 2010 state: ¿this (b)(6)-year-old woman has developed a recurrent subxiphoid abdominal wall hernia, for which she is seeing dr.(b)(6) for surgical repair.¿ ¿she has a background history of known coronary heart disease with previous pci to the lad and mid rca in (b)(6) 2005 and a bare-metal stent to the distal right coronary artery in (b)(6) 2007.These procedures were done at (b)(6) medical center.In (b)(6) 2008, while she was in the (b)(6), area she underwent triple coronary bypass grafting.She had developed severe dyspnea at that time.Details of her surgery are not currently available to me, but we have requested records.She has not had any recurrence of that type of dyspnea.She has chronic substernal and epigastric discomfort which has been related to gastroesophageal reflux disease and her recurrent abdominal wall hernia.She had previously considered bariatric surgery but that procedure was put off because of her need for bypass surgery, and she has subsequently had several repairs of her ventral hernia without a successful long-term result.¿ abdominal exam notes state: ¿severely obese, aorta not palpable, liver not palpable, epigastric hernia.¿ on (b)(6) 2010: (b)(6) medical center.(b)(6), md.History and physical.Status post a 3-vessel coronary artery bypass graft in 2009 performed in (b)(6) which was reportedly complicated by a wound infection requiring multiple debridements ¿ she subsequently underwent a mesh repair of her epigastric incisional hernia.She presented to an outside facility following an approximate 3-week history of intermittent nausea and vomiting with concurrent protraction of her known epigastric hernia ¿ by her report this area would become ¿hard¿ and nonreducible when she became nauseated.She also reports a history of rather quick onset of nausea and vomiting following a bolus of either solids or liquids.The patient notes that when the area is soft she is not nauseated.She feels her symptoms are exacerbated by activity and relieved by rest.Initially seen at outside facility and discharged but re-presented due to intractable nausea and vomiting.Just prior to her transfer, an ng tube was placed which is presently draining minimal amount of gastric contents.The patient denies any present nausea, vomiting, shortness of breath, chest pain, or any other area of discomfort.Exam: abdomen obese, soft, well healing broad midline vertical incision with incorporated skin graft, epigastric hernia, not incarcerated, obvious gas filled structure immediately underlying the hernia defect.Assessment and plan: intermittently incarcerating epigastric hernia.Extraneous abdominal supportive device will be devised in order to maintain gentle pressure at patient¿s hernia site to hopefully preclude recurrence of patient¿s incarceration.On (b)(6) 2010: (b)(6) medical center.(b)(6), md.Operative report.Pre/postop diagnosis: incarcerated/obstructing, paraomental (ventral incisional/diaphragmatic) hernia.Procedure: extensive laparoscopic lysis of adhesions.Repair of paraomental (combination of ventral incisional and diaphragmatic) hernia laparoscopically.Placement of mesh for hernia repair.Complications: loss of the tip of gore suture passer and subcutaneous tissue.Indications for procedure: the patient presents with a history, exam, ct scan consistent with a paraomental hernia following prior omental flap for sternal wound dehiscence.She has had two failed repair and is admitted now with a history and exam consistent with incarcerating stomach and obstruction.Subsequently, after failure of abdominal binder for treatment of this, repair was felt appropriate.Operative findings: the patient had a relatively small defect measuring approximately 3 cm in diameter.The contents included distal stomach and proximal duodenum as well as omentum as expected.The contents included distal stomach and proximal duodenum as well as omentum as expected.The contents were reduced and the omental pedicle was then amputated at the level of the defect.The region was repaired using a 10-cm diameter gore-tex dual mesh secured with a combination of full-thickness transfacial fixation sutures as well as diaphragmatic sutures as well as 5-mm hernia tacks.Description of procedure: ¿the patient was taken to the operating room and placed on the table in supine position.General anesthesia was induced.Sterile prep and drape was performed.Local anesthesia was instilled and a left subcostal incision was created with an 11 blade.A 5-mm optical trocar was inserted into the peritoneal cavity and co2 insufflated to create a pneumoperitoneum to 12 mmhg pressure.A 5-mm 30-degree laparoscope was inserted confirming atraumatic intraperitoneal trocar placement as well as extensive adhesions.Under direct visualization after local anesthesia and small skin incision, an infraumbilical 5-mm trocar was placed and another 5-mm trocar was placed in the right upper abdomen laterally.This was later upsized to a 12-mm trocar to accommodate the mesh.The scope was relocated to the umbilical trocar to facilitate triangulation and extensive adhesiolysis was carried out sharply.There were multiple loops of bowel adherent to the anterior abdominal wall.Fortunately, these adhesions were for the most part relatively flimsy and were able to be taken down safely.The bowel was examined carefully after adhesiolysis to be sure there was no enterotomy.After adesiolysis, exposure to the hernia was achieved and it was noted that the distal stomach and proximal duodenum were within the defect.With the combination of internal manipulation and external palpation bluntly, the contents were reduced.What remained was the omental pedicle.It was felt appropriate to divide this in order to more definitively repair the hernia defect.The harmonic scalpel was used to divide the omental pedicle at the level of the hernia defect and this region was hemostatic.The defect was measured intracorporeally and was found to be just under 3 cm in diameter.Subsequently, a 10 cm diameter circular gore-tex dualmesh was felt appropriate to provide wide coverage with an overlap of greater than 3 cm circumferentially.The mesh was prepared extracorporeally by placing 0 ethibond sutures at the 3, 6, and 9 o¿clock positions and then was rolled up and inserted into the peritoneal cavity via the 12-mm trocar.Once positioned intraperitoneally, the mesh was secured initially at the 12 o¿clock position with intracorporeal suture of 0 ethibond to the diaphragm.The remaining three sutures were then pulled up through the anterior abdominal wall using the suture passer with a 1 cm fascial bridge at each site.Of note, during the first attempt using the gore suture passer, the tip of the gore suture passer broke off in the deep subcutaneous tissue, likely at the junction of the old mesh.This could not be easily located and since it was within the deep subcutaneous tissue and probably lodged within the old mesh and not intraperitoneal, was not felt necessary to further pursue localization of this, especially as it was felt highly unlikely that this would be identified.Following this, multiple 0 ethibond interrupted sutures were used to secure the mesh to the diaphragm from the 9-12 o¿clock position and the 12-3 o¿clock positions.The 5-mm hernia tacks were used to secure the mesh from the 3-6 o¿clock positions and 6-9 o¿clock positions.This essentially was overlapping the previously placed mesh.Upon completion, the tack and suture fixation sites were examined and were hemostatic.The 12-mm trocar was removed and this fascial defect approximated with a 0 ethibond, again placed using the suture passer.The remaining trocars were removed as the pneumoperitoneum was evacuated.All sites were hemostatic.The skin at the trocar sites was approximated with 4-0 vicryl subcuticular and dermabond.Dermabond alone was used for the mesh fixation sites.The patient has since been extubated and plans for transfer to pacu.¿ on (b)(6) 2010: (b)(6) medical center.Implant log.Implant sticker.Manufacturer¿s instructions followed for rinsing tissue implants.Label: gore dualmesh® biomaterial.Ref catalogue number: 1dlmc03.Lot batch code: 7225059.W.L.Gore & associates.The records confirm a gore® dualmesh® biomaterial (1dlmc03/7225059) was implanted during the procedure.On (b)(6) 2010: (b)(6) medical center.(b)(6), md.Discharge summary.Hospital course: initially treated conservatively with binder with bolster.Continued to have nausea and vomiting, ngt was inserted.Post-op, had minimal pain, nausea began improving.Incision remained clean and dry with steristrips itact [sic] and no erythema.Prior to discharge, the patient was ambulating well, tolerating a diet with no ill effects.Discharge diagnoses: incisional hernia ¿ s/p repair with mesh.No heavy lifting.Operative records for a ¿recurrent subxiphoid abdominal wall hernia¿ repair performed in (b)(6) 2010 were not provided.Cardiac evaluation records dated (b)(6) 2012 provide the following medical history: ¿ascvd: status post percutaneous coronary intervention, 2005.Repeat percutaneous coronary intervention in 2007.Subsequent coronary artery bypass grafting, (b)(6) medical center.Post-bypass sternal infection, status post repeat debridement and skin grafting, though without resection of the sternum.Sternal incisional hernia, status post repair with mesh.¿ records detailing the ¿post-bypass sternal infection, status post repeat debridement and skin grafting, though without resection of the sternum¿ were not provided.Records between (b)(6) 2012 and (b)(6) 2014 were not provided.Records dated (b)(6) 2014 state the patient was seen for abdominal pain and possible recurrent abdominal wall hernia.Surgical history states: ¿open paraomental hernia repair with mesh (b)(6) 2009; laparoscopic paraomental hernia repair with mesh (b)(6) 2009; [laparoscopic] paraomental hernia repair with mesh (b)(6) 2010.¿ operative records for the ¿open paraomental hernia repair with mesh (b)(6) 2009¿ and ¿[laparoscopic] paraomental hernia repair with mesh (b)(6) 2010¿ procedures were not provided.History and physical from the (b)(6) 2014 visit states: ¿presents with pain.Duration 1 month.Located in the right upper quadrant.The pain is intermittent.The severity of the pain is moderate.Aggravating factors include exertion, initially felt it after lifting.Bowel function unchanged.Bladder function unchanged.¿ exam notes state: ¿gastrointestinal: obese.Bowel sounds present, soft, nondistended, well healed surgical scar in midline.Focal tenderness and subtle fullness in right mid to upper abdomen.¿ the records indicate a ct of the abdomen and pelvis was performed, which showed ¿possible upper abdominal hernia.¿ records for the ct performed in (b)(6) 2014 were not provided.Ct scan records dated (b)(6) 2014 state: ¿clinical information: abdominal pain, suspect hernia.¿ ¿there is no small bowel obstruction.A minimal hiatal hernia is present.No acute diverticulitis is present.¿ ¿adjacent and posterior to the mesh in the anterior abdominal wall there is a fluid density structure measuring 16 cm in height, 15 cm in width and 5.6 cm in ap dimension.It is difficult to determine whether this is in the intraperitoneal space or just outside of the peritoneum.The mesh itself has an irregular appearance.Anterior to the mesh within the subcutaneous fat plane there are strandings of fluid density.Additionally, there is an ill defined abnormal soft tissue density structure measuring approximately 4 cm; this may represent a phlegmon although hematoma-like structure cannot be ruled out.Note that intravenous contrast was not utilized; therefore, status of inflammatory changes in this region cannot be adequately assessed.¿ conclusion from the (b)(6) 2014 ct scan states: ¿presence of large relatively well defined fluid density structure immediately adjacent/ posterior to the abdominal mesh, as discussed above.Phlegmon-like structure anterior to the mesh within the subcutaneous fat plane with inflammatory changes.¿ an addendum dated (b)(6) 2015 states the ct results were discussed with the patient, which showed ¿post operative changes including, prior meshes, a chronic seroma, the residual omental pedicle, and affiliated scar/inflammation noted.No evidence of hernia, infection, or intra abdominal process.¿ there are no product identification records for the devices implanted in the patient in addition to the gore dualmesh® plus biomaterial.Records dated (b)(6) 2015 state the patient was again seen for abdominal pain.¿located in the mid abdomen and now associated with erythema.Seen by pcp last week and started on po antibiotics without improvement.The pain is a constant "soreness" and worsening.¿ ¿a ct (computed tomography) scan of the abdomen repeated last week and shows persistent (?slightly smaller) fluid collection beneath the intra peritoneal gore-tex mesh and increasing inflammatory changes in the subcutaneous tissues that does not clearly communicate with the gore-tex mesh.¿ records for the recent ct scan were not provided.Operative records dated (b)(6) 2015 state the patient underwent ¿abdominal exploration.Debridement of skin and subcutaneous tissue.Mesh explantation.Vac dressing placement.¿ indications for the procedure states: ¿this patient presents with an increasingly painful abdominal mass.Ct and clinical exam reveal findings consistent with an inflammatory/infectious process within the subcutaneous tissue.The patient does have a history of multiple prior hernia repairs with mesh placement and subsequently it was felt that at least one of her underlying meshes was the nidus for this process and exploration was felt appropriate and decided upon after discussion with the patient.¿ there are no product identification records for the devices implanted in the patient in addition to the gore dualmesh® plus biomaterial.Operative findings from the (b)(6) 2015 procedure state: ¿the patient had evidence of significant chronic inflammatory change.There appeared to be a fat necrosis and a wound sinus extending from one of the more superficial mesh pieces to the skin.The deepest mesh was not encountered and this was felt to be intraperitoneal.There was a large amount of fluid encountered that was felt to be a chronic seroma.This was sent for gram stain and was negative for bacteria.After debridement and explantation of the superficial mesh, a vac dressing was placed.The wound measured approximately 11 cm longitudinally x 8 cm transversely x 4 cm deep.¿ it is unclear from the medical records which mesh was noted to be ¿the deepest mesh.¿ there are no product identification or implant records for the devices implanted in the patient in addition to the gore dualmesh® plus biomaterial.The (b)(6) 2015 operative report states: ¿sterile prep and drape was performed, local anesthesia was instilled, and a longitudinally oriented elliptical incision was created with a scalpel around the abnormal region.Electrocautery was used to divide the subcutaneous tissue and to create a "core" of tissue that included the chronic inflammatory change.As this continued down to the abdominal wall, an obvious mesh prosthesis was encountered.This appeared to have folded up and contracted and formed a "meshoma." this was clearly contiguous with the process and was felt to likely be the nidus of the process.This was able to be excised/explanted at the level of the abdominal wall.This was sent as a specimen.Of note, the specimen was later opened on the backtable and there was a clear sinus tract extending from the mesh to the skin with significant amount of what appeared to be fat necrosis and chronic granulation.This was sent for culture.¿ it is unclear from the medical records which mesh was found to be a ¿meshoma.¿ product identification and implant records for devices implanted in the patient other than the gore dualmesh® plus biomaterial were not provided.The (b)(6) 2015 operative report continues: ¿following this, the wound bed was examined.There was one area where there was a small, 1 cm opening and with pressure, a large amount of serous fluid was returned.The preoperative ct scan did show a deep seroma and this was felt to likely be fluid from the seroma.As this appeared to be contiguous with the deep mesh on ct scan, it was felt appropriate to send this for stat gram stain to rule out infection.This came back 1 + polys and no recognizable bacteria.Subsequently, it was not felt necessary to explore the deeper mesh, which again could not be visualized and did not appear to be contiguous with the current process.As much of the fluid as possible was evacuated, which was a total of approximately 200 ml.At this point, the wound was irrigated and was hemostatic.A v ac dressing was placed.¿ it is unclear from the medical records which mesh was noted to be ¿the deep mesh.¿ product identification and implant records for devices implanted in the patient other than the gore dualmesh® plus biomaterial were not provided.On (b)(6) 2015: (b)(6) medical center.(b)(6), md.Brief op note.Post op plan: continue bactrim, will plan to continue this for another 2 weeks from today.Vac change on friday with oral meds, then home after that if tolerates it well.1 piece of sponge placed.Operative findings: sinus track from old mesh (superficial to the mesh placed by dr.(b)(6)) up to nearly skin surface with fat necrosis.Fat necrosis sent for culture.Did not appear to freely communicate with the seroma known to be associated with the deepest mesh, but this was entered with gentle further probing, drained and sent for stat gram stain, which was negative.Final wound measured 11 cm length x 8 cm width x 4 cm depth.Complications: none.Specimens: mesh, fat necrosis, sinus track, skin and subcutaneous fat.Drains: vac dressing to resulting wound.Rationale for antibiotics to be continued beyond prophylactic dose(s): pre-existing infection.Culture (b)(6) results dated (b)(6) 2015 regarding a specimen collected (b)(6) 2015 states: ¿no (b)(6) isolated.¿ a surgical pathology report dated (b)(6) 2015 regarding specimens collected (b)(6) 2015 states: ¿specimen: [abdominal wound], skin, subcutaneous tissue, sinus tract.¿ ¿the specimen is received unfixed labeled ¿abdominal wound skin, subcutaneous tissue, sinus tract and old mesh.The specimen consists of a piece of fibrofatty tissue with embedded mesh material and attached slightly pigmented nodular skin.The specimen measures 11.0 x 9.0 x 4.8 cm.The skin measures 9.0 x 3.0 cm.The mesh is embedded at the posterior aspect of the specimen.Sectioning shows a sinus tract extending from the mesh to the surface of the skin.The tract measures 6.0 cm in length with a diameter of 1.2 cm.It contains a bloody thick fluid.¿ ¿final diagnosis: skin and subcutaneous tissue, abdomen, excision: benign skin and subcutaneous tissue with acutely inflamed granulation tissue.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2009 whereby a gore dualmesh® plus biomaterial with holes was implanted.The following was reported that on (b)(6) 2015: ¿¿patient presented with complaints of increasingly painful abdominal mass.Ct scan revealed findings consistent with inflammatory/infectious process.Patient underwent open surgery for wound debridement and partial mesh removal.The mesh was noted to have "folded up and contracted and formed a 'meshoma'".The mesh was opened after removal and "a clear sinus tract extending from the mesh to the skin with [significant] amount of what appeared to be fat necrosis and chronic granulation" were noted.Patient has also had a seroma drained.[cultures] of the seroma were negative for bacteria.The resulting hernia was not repaired but rather a wound vac was placed.The patient had a wound vac for 30 days and then home health care 3 x weekly for about 18 months until the wound closed.¿ the complaints states: ¿on [(b)(6) 2016], plaintiff underwent another open surgery due to the gore mesh being infected and causing a severe [inflammatory] response.A large abscess, which was noted as purulent fluid, was located beneath the mesh and was drained.[inflamed] and necrotic tissue was also noted [surrounding the] mesh.The necrotic tissue was [debrided] and the mesh was removed.A wound vac was also again placed and was in place for about 2 months.¿ the complaint continues: ¿the patient required another open surgery on (b)(6) 2017 after her wound had opened back up.All of the mesh had not been previously removed and surgery was again required remove the remaining pieces to and to lyse adhesions from mesh and abdominal wall.A "inflammatory capsule" was observed as surrounding the mesh.It was reported the patient alleges the following product deficiencies: contraction, inflammation/foreign body reaction, and infection.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated results code 1 for manufacturing evaluation.Conclusion code remains unchanged.H6: added method/results/conclusions code 2 for sterilization evaluation.
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Manufacturer Narrative
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H6: updated results code 2 for sterilization evaluation.Conclusion code remains unchanged.
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Manufacturer Narrative
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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: (b)(6) 2007: (b)(6) hospital.(b)(6) md.Radiology-ct abdomen/pelvis w/ iv contrast.Clinical information: right groin, abdominal pain.Findings: widening & ill definition of right rectus muscle for approximately 12 cm in length and 3.9 cm in thickness at pelvic level likely to represent hematoma within right rectus muscle.Elongated soft tissue density within the right lateral aspect of the low abdomen and pelvis measuring 17 cm in length and 1.9 cm in thickness.This represents a hematoma within intraperitoneal fat plane.No free fluid is noted in abdomen and pelvis.Conclusion: hematoma w/in right rectus at level of pelvis.Intraperitoneal hematoma along r lateral aspect of low abdomen & pelvis.(b)(6) 2009: (b)(6) hospital.(b)(6) md.Ed report.Cc: epigastric pain 7/10, past few months, progressively worse since 4 days prior, ¿it feels like my hernia is back¿.Smokes 1 ppd or so.Exam: abdomen; normal bowel sounds, soft, significantly tender in epigastrium.Impression: epigastric pain of uncertain cause.Treated & released.Condition stable.Discharged home on no specific diet or activity changes because medications here did not work.Return for worsening symptoms, further concerns.(b)(6) 2009: (b)(6) hospital.(b)(6) md.Radiology-abdomen obstructive series.History: pain.Findings: demonstrates morbid obesity.Flat & upright of abdomen fail to reveal free air.I see no significantly dilated loops of large or small bowel or significant air-fluid levels.Hernia fixation coils are present overlying mid abdomen.Impression: suboptimal exam failing to demonstrate acute diagnostic abnormalities.(b)(6) 2009: (b)(6) hospital.(b)(6) md.Radiology-ct chest/abdomen w/o iv contrast.History: abdominal pain, history of hernia, right lung nodule.Findings: large hernia mesh anterior abdominal wall with probable seroma between the mesh and peritoneal reflection.Multiple fixation coils present.Impression: seroma adjacent to anterior abdominal wall hernia mesh.Hernia defect superior to mesh extending into anterior chest wall.No intraabdominal abnormalities identified.(b)(6) 2010: (b)(6) hospital.(b)(6) do.Consult.Cc: chest pain radiating to left jaw relieved by nitroglycerin.H/o epigastric pain s/p band procedure.Smokes ½ pack cigarettes per day.Possible she is having angina.Could also be gastric in origin given her previous history.Send pt home w/ rapid follow-up w/ stress testing.(b)(6) 2010: (b)(6) hospital.(b)(6) ed report.Cc: vomiting, abdominal pain.Hpi: long-standing h/o chronic abdominal pain w/ known incisional hernia.Scheduled for surgery w/ dr.(b)(6) due to displacement of some of the mesh from prior surgeries.Had episode of vomiting over last 24 hrs.Abdominal films showed no obstruction.Pmh: multiple debridements of incisional hernia repair.Quit smoking 2 days ago.Meds: aspirin.Abdomen: obese, bowel sounds present.Site of abdominal epigastric hernia is present, palpable.Belly otherwise soft w/ no significant pain.Clinically improved & pt wished to be discharged.Had another episode of vomiting prior to discharge.(b)(6) 2010: (b)(6) hospital.(b)(6) md.Radiology-abdomen special.Clinical information: abdominal pain, vomiting.Findings: bowel gas pattern nonspecific w/o any evidence of bowel obstruction.Conclusion: no radiographic evidence of acute intrathoracic or intraabdominal abnormality.Evidences of previous intraabdominal surgery.No convincing radiographic evidence of bowel obstruction.(b)(6) 2010: (b)(6) hospital.(b)(6), pa-c.Progress note.Feeling better today.Impression: abdominal pain related to recurrent incisional hernia in epigastric area.Plan: advance diet & consider discharge today.I feel that these are very low risk at this time for this patient.Unclear what made the difference other than some iv rehydration.(b)(6) 2010: (b)(6) hospital.(b)(6) md.Discharge summary.Hpi: pt has had problems with recurrence of incisional hernia.Abdomen: healed sternal wound.No obvious protrusion along incision line.Some tenderness to palpation in mid epigastrium.Over subsequent 48 hrs, pt was able to take regular diet and did not require pain or antiemetic medications.D/c dx: nausea & vomiting, presumably related to known recurrent incisional hernia.(b)(6) 2010: (b)(6) hospital.(b)(6), pa-c.Ed report.Cc: vomiting & abdominal pain.Has a central abdominal hernia, has increased over the evening.She said it was really hard.Moderately ill-appearing.Abdomen: decreased sounds.Large central hernia underlying what appears to be an old skin graft.Soft, does not appear to be reducible at this point; although i am not sure that it is coming through a small hole.I think there is a large hole in the abdominal wall.(b)(6) 2010: (b)(6) hospital.(b)(6) md.Radiology-abdomen special.Clinical information: abdominal pain.Findings: bowel gas pattern nonspecific w/ moderate amount of feces in the colon.No suspicious intraabdominal calcification.No bowel obstructive change is present.Conclusion: no acute intrathoracic or intraabdominal abnormality.(b)(6) 2010: (b)(6) hospital.(b)(6) do.Transfer summary.Disposition: to be transferred to care of dr.(b)(6) medical center.(b)(6) 2015: (b)(6) hospital.(b)(6).Radiology-ct abdomen w/o iv contrast.Clinical information: painful mass along prev.Ventral hernia repair site.Immediately adjacent/posterior to the abdominal wall mesh there is a well defined fluid structure measuring 14 x 3 cm in sagittal dimension and 15 cm in transverse dimension.This is smaller compared to the previous study.Anterior to mesh is ill defined abnormal phlegmon-like change in the subcutaneous fat plane; this measures approximately 7.5 x 8.8 x 4 cm; this shows interval increase in size.This structure is surrounded by inflammation.Conclusion: phlegmon-like structure anterior to the abdominal wall mesh surrounded by inflammatory changes w/ interval worsening from (b)(6) 2014.Clinical correlation recommended.(b)(6) 2016: (b)(6).Office visit.Hpi: h/o recurring abdominal wall hernias & also intra-abdominal abscess in the past presents w/ a 24-hr h/o swelling, tenderness over the right mid to lower abdomen which came up quite suddenly.Progressively larger, more uncomfortable as day progressed.Additionally reports usual bowel irregularity w/ fluctuating diarrhea and constipation.Abdomen: old well-healed surgical scars.Does have an area of light erythema overlying significant area of swelling to the right of midline toward the mid lower part of the abdomen.This is many centimeters across, firm, and exquisitely tender to palpation.Assessment/plan: abdominal mass: suspected to be another intra-abdominal abscess and/or atypical recurrence of a ventral hernia.(b)(6) 2016: (b)(6) hospital.(b)(6) pa-c.Ed provider report.Cc: abdominal pain.Sharp, no radiation, in rlq.Started today is still present and now worse.Severity described as moderate.Pain (b)(6) 2010.Abdomen; soft, tenderness rlq.Bowel sounds normal.Obese.Abdominal sonogram: (area of redness at right lower abdomen.Seroma noted, but abscess cannot be excluded at scar ¿ 8.5 x 5.4 x 7.3 cm.At site of redness, superficial edema w/ focal area of echogenic mobile debris - ? cellulitis w/ areas of phlegmon).Wbc 15.1.Clinical impression: cellulitis of abdominal wall.(b)(6) 2016: (b)(6) hospital.(b)(6) md.History & physical.Hpi: hx abdominal wall abscess that apparently was related to wounds and somehow tied in with surgery for an abdominal wall hernia.Was feeling well up until this morning when she had some pain in rlq area and noticed some redness.She is quite tender in that area.Has had some chills today, but no known fever.Reviewed cultures done from drainage of the abscess from that admission at main medical center and there was no growth at that time.Ros: chronic bowel problems since previous surgeries w/ alternating diarrhea and constipation.Abdomen: numerous, mostly midline, surgical scars which are healed.No areas of drainage and no redness over scars.Area of redness w/ rather exquisite tenderness in the skin in the rlq area and most tender right in the middle of that area of redness, but is well away from the scars except for it¿s approaching a lateral scar in the right side.No obvious fluctuance.Very minimal tenderness over main midline scar but is fairly minimal and there is no guarding at that area.Wbc 15,100.Ultrasound of abdomen superficially showed a seroma under the scar described above, but that was away from the area of redness where there were no signs of abscess but it was felt to show inflammation.Assessment: abdominal wall cellulitis.Does have underlying seroma, seems to be away from area of cellulitis so likely unrelated to previous problems.No h/o mrsa that we can determine.Plan: will treat empirically w/ vancomycin and clindamycin due to cephalosporin allergy.Blood cultures have been drawn before starting antibiotics.Will see how she does over next 24 to 48 hours.If she does not improve, then i would be concerned of communication w/ the seroma and may require repeat ultrasound and surgical consultation.(b)(6) 2016: (b)(6) hospital.(b)(6).Radiology-ultrasound abdomen-limited.Clinical information: mass, right lower abdominal pain.Findings: scanning is obtained in the right lower abdominal wall in the region of redness.At/ near the previous surgical scar, there is a heterogenous fluid collection measuring 8.5 x 5.4 cm.This may represent a complicated seroma, although abscess cannot be entirely excluded either in appropriate clinical context.Additionally, there is a generalized superficial edema, containing fluid.Some of these regions show echogenic mobile debris.The possibility of cellulitis w/ regions of phlegmon are suspected.There is no definable containment of these structures to suggest abscess.Conclusion: cellulitis w/ areas of phlegmon, corresponding to the region of redness in the right lower abdominal wall; infectious process should be considered.Additionally, complicated seroma-like structure is also suspected in the region of the surgical scar as described above; further evaluation is recommended.(b)(6) 2016: (b)(6) hospital.Lab results.Peripheral blood culture.Comments: anaerobic blood culture bottle was not drawn.Final report: no growth.(b)(6) 2016: (b)(6) hospital.(b)(6) np.Progress note.Subjective: blood cultures negative so far and she is improving nicely.Assessment & plan: abdominal wall cellulitis.Continue current plan of iv antibiotics.(b)(6) 2016: (b)(6) hospital.(b)(6) md.Progress note.Pt had change in status.Reports increasing abdominal discomfort, as well as an area around previous problems with her cellulitic changes that now seems to be swelling and protruding.Pt appeared to be doing a bit better yesterday, but these changes started occurring last night.Describes exquisite tenderness over area of concern.Nursing reports that this area is now approximately the size of a tennis ball, is more bulging, and was not tender yesterday.T-max yesterday was 99.3.Abdomen: morbidly obese.Does have an area outlined of previous borders of her cellulitic changes and the appear to be improving, but she now has a bulging area approximately the size of a tennis ball in left upper portion of previously described outline.Exquisitely tender, but soft to palpation.Assessment & plan: previously diagnosed abdominal wall cellulitis.Now has an area that i would suspect is an organizing abscess.Exquisitely tender and enlarging in size.No evidence of leukocytosis and has not had a fever.Recommend rechecking an ultrasound to compare to admission ultrasound to see if this has changed.(b)(6) 2016: (b)(6) hospital.(b)(6) radiology-ultrasound abdomen-limited.Clinical information: worsening abdominal pain and suspected organizing abscess.Comparison made w/ previous study date 09/28/16.Scanning of the right lower abdominal wall at/ near the previous surgical scar, there is a well-defined heterogenous-appearing fluid collection measuring 9.6 x 4.3 x 8.3 cm compared to a previous measurement of 8.4 x 5.4 x 7.3 cm.Along the superficial redness/ edematous changes, a subcutaneous fluid collection is noted with heterogenous region/ material suspicious for presence phlegmon.Infectious process is suspected.This is not a well-confined, definable structure.Conclusion: cellulitis w/ evidence of phlegmon; these are more prominent compared to (b)(6) 2016.Additionally, complicated seroma-like structure at/ near the surgical scar shows an interval slight increase in size.Clinical correlation is recommended.(b)(6) 2016: (b)(6) hospital.(b)(6) md.Progress note.Feels abdominal pain has slightly improved, though continuing to take vicodin on regular basis.Abdomen: ongoing cellulitic changes in rlq.I do not think there has been a lot of change from yesterday.Still a palpable area of approximately a tennis ball size that is somewhat tender.Assessment & plan: abdominal wall cellulitis and probable underlying abscess.Pt was seen by general surgery and he believes that this is most certainly an abscess and very likely will require surgical intervention.Continue iv antibiotics, chest ct scan of abdomen today, consult w/ dr.(b)(6) tomorrow after results of ct are known to discuss additional plans.(b)(6) 2016: (b)(6) hospital.(b)(6) md.Radiology-ct abdomen/pelvis w/ iv contrast.Clinical information: possible abscess, question involvement of mesh/colon.Within the abdomen, there is again evidence of a discrete fluid collection identified subjacent and just deep to the anterior abdominal wall mesh.There is evidence of new air and air-fluid level identified w/in this collection worrisome for a secondary infection and abscess information.The overall size of 11.5 cm sagittal by 3.4 cm ap by 14.8 cm transverse is identified, fairly similar to slightly decreased compared to previous.Anterior to the mesh w/in the subcutaneous fat, there is again evidence of abnormal density seen w/ more discrete margins on the current study.This measures approximately 7 x 5.5 x 12.6 cm.This has increased in size compared to previous.There is no new internal gas collection or air-fluid level identified.There is subjacent soft tissue stranding and inflammatory change extending to the skin surface.Within the pelvis, there is no free fluid or inflammatory change identified.There are no dilated loops of bowel identified.Impression: new air-fluid level w/in fluid collection deep to the marlex mesh worrisome for abscess formation.Increase in size of the subjacent subcutaneous fluid collection anterior/superficial to the mesh.While there is no air-fluid level, an infectious process/ abscess is suspected given the surrounding inflammatory changes.This could also represent hematoma.(b)(6) 2016: (b)(6) hospital.(b)(6) md.Progress note.Has had minimal improvement.Slight reduction in erythema of the area, but underlying tissue abscess seems to be larger.Abdomen: obese.Persistent cellulitic changes of rlq.Palpable area size of an eggplant which is somewhat tender.Imaging: verbal report from dr.(b)(6) regarding ct of abdomen reveals there is a fluid collection near the mesh w/ a developing air-fluid level in the superior aspect.Also a second subcutaneous collection anterior to the mesh which appears to be enlarging in size.Assessment & plan: 1) abdominal wall cellulitis, persistent, w/ suspecting of underlying abscess.Ultrasounds have revealed slight progression of size of abscess.Dr.(b)(6) has seen pt and feels this is an abscess and will probably require surgical intervention.Had abdominal mesh and subsequent infection at her last surgery about 1-1/2 yrs.Ago.Continue iv antibiotics.(b)(6) 2016: (b)(6) hospital.(b)(6) np.Transfer summary.Dc dx: abdominal wall cellulitis w/ abdominal wall abscess to marlex mesh w/ air-fluid level collection.Subcutaneous fluid collection anterior and superficial to mesh.Discussed case w/ (b)(6) md, who recommended percutaneous drainage of superficial abscess by interventional radiology w/ a need to sample fluid under the mesh.Will need to be transferred to maine medical.Abdomen: obese, positive bowel sounds.Rlq abdominal wall w/ pale erythema approximately 6 inches in diameter and 10 inches in length.Palpable area approximately the size of a softball, but somewhat elongated and tender.(b)(6) 2017: (b)(6) hospital.(b)(6) , md.Radiology-ct abdomen & pelvis w/o iv contrast.Clinical information: subcutaneous abscess s/p hernia repair, abscess drainage.Findings: within the abdomen, there is again evidence of an anterior abdominal wall mesh identified.The previous air-containing fluid collection is no longer present.There is mild soft tissue thickening seen at the distal aspect of the residual mesh in the anterior midline and supraumbilical region extending to the level of the umbilicus w/ mild surrounding stranding.This is presumed residual postsurgical change.No new discrete collection or air-fluid level is identified.The non-contrasted liver, spleen, pancreas, kidneys, adrenals and abdominal aorta demonstrate no acute changes.Diffuse hypodensity of the liver suggests fatty infiltration.Small gallstones are noted.No significant adenopathy identified.Within the pelvis, there is beam hardening artifact related to the patient¿s body habitus.Allowing for this, no gross pelvis free fluid can be seen.There are no significantly dilated loops of bowel identified.Impression: significant improvement w/ resolution of previous abscess collection associated w/ the mesh.There is mild supraumbilical and umbilical soft tissue density and stranding which could be postsurgical, and/ or scarring.No new fluid collection is seen.An additional follow-up could be considered to confirm resolution.(b)(6) 2017: (b)(6) hospital.(b)(6) md.Ed provider report.Cc: dizziness, vertigo.States, ¿i feel off today.I have this sore on my abdomen and i just hope it hasn't caused a bad infection.¿ started today & is still present.Impression: significant improvement w/ resolution of previous abscess collection associated w/ mesh.Mild supraumbilical and umbilical soft tissue density and stranding which could be postsurgical and/ or scarring.No new fluid collection seen.Additional follow-up could be considered to confirm resolution.Site of previous abd.Surgery is draining slightly, purulent material.Appearance: anxious.Abdomen: surgical site has mild drainage, no focal erythema or signs of cellulitis.Worsening dizziness w/ rotation of head.Glu 254, alk 120.Clinical impression: benign positional vertigo.(b)(6) 2017: (b)(6) hospital.Lab results.Abdominal wound culture.Final gram stain: many polymorphonuclear wbcs.Few gram positive cocci in pairs & in clusters.Final wound culture: staphylococcus aureus, light growth.Methicillin resistant? no.(b)(6) 2017: (b)(6) hospital.(b)(6) , md.Wound clinic progress note.Seen for draining sinus tract above umbilicus, midline.Developed about 2 months ago.Has h/o issues w/ abdomen that go back to 2008, when she was in ny and had 3-vessel bypass surgery for heart & had issue w/ open wound.Sounds like they needed to remove the sternum and did skin grafting.Then developed an incisional hernia about a year later and had plastic surgery done w/ repair of this hernia.Then she needed to have it done 2 or 3 more occasions because of protuberance in this area that would redevelop.Pt had mesh placed couple times in (b)(6) 2009.Had some issues w/ vomiting, diarrhea and abdominal discomfort in 2012.4th time had surgery on belly with dr.(b)(6).Then developed an abscess probably related to mesh back in (b)(6) 2015, and then had another episode (b)(6) 2016 when she was initially admitted to (b)(6) memorial.Developed abscess formation around the mesh.Was transferred to maine medical center where this was cleaned out and had vac treatment.Has had 2 vacs placed to abdominal wounds w/ good healing.Unfortunately, she reopened up again about 2 months ago.Has been draining from just above her umbilicus from a draining sinus tract.Does drain a fair amount at times, a yellowish green material.Pt states she has some vomiting at times.Sounds like reflux.Does get abdominal discomfort across her belly that is located just above her umbilicus, across her belly.Stools can be solid to loose.I do not believe she is having any fever or chills at this time.Her appetite is up and down.Has been using moist gauze to the wound.Last saw dr.(b)(6) about 2 weeks ago.Referral was made from dr.(b)(6) to wound center because of this draining sinus tract that does not look currently infected.Eating is up and down.Seems to walk fine.Wt has been an issue over the years.Quit smoking 8 months ago.Does not drink.Pmh: diabetes, obesity, osa, female stress incontinence.Abdomen: looking at her belly i do not feel any liver or spleen enlargement.Has a massive belly.You can see surgical skin transplant they did on the sternal region that reaches down to the upper abdomen on her belly.Bowel sounds quiet.Not distended.Nontender to palpation.Insensate over skin graft over sternum and upper abdomen and also where she has some surgical scars that probably developed over past couple of years.Seems to be insensate.Not tender around her wound.Wound is located on a couple cm above umbilicus.Measures 0.5 cm x 0.7 cm.I can take a sterile q-tip and it goes in gently up to about 0.7 cm.Some fibrous nonviable tissue that comes out of this wound.No periwound evidence of any cellulitis.Not foul smelling at all.Fair amount of drainage on dressing that was removed.No odor to it, but definitely has discoloration to it which is yellow and greenish and on the thickish side.As i palpate and massage her belly i was unable to express and significant amount of fluid out.I do not detect an abscess in her belly.There is no mass that i could feel.Skin is taut around wound from scar tissue from previous probably i & d¿s or previous surgical approaches.Used some vashe on some gauze to clean the area.Did a swab culture.Stringy stuff that was protruding from the wound was removed w/ a scalpel blade for tissue culture.No significant bleeding occurred.Wound was not explored other than using a q-tip just to gently gauge minimal depth to it.From looking at ct scan it looks like it does approach about 2(+) cm.Q-tip did enter about 0.7 cm.No foul odor to this.No pus that i can see except on the drainage it looked pustular as far as yellow green thickish color w/o odor.Nothing tender about pt¿s exam.Then dressed it w/ gauze, abd pad and medipore tape.There is some tape disruption to the skin and i have asked her to be careful w/ that.Do not detect any distention of belly.No increased tympany.No tenderness to palpation.I have reviewed ct scan done (b)(6) 2003.You can still see some mesh in upper portion of the belly.I do not see any abscess.You can see a fair amount of scarring in subcutaneous tissue.Appears the mesh has been all removed around the umbilical region and below.Assessment: female w/ obesity who has had mesh placed in on a couple of occasions who most likely has contaminated mesh that has colonized and will create persistent problems of abscess formation, currently draining on its own now, draining non-foul smelling material and draining a fair amount each day; probably a couple of tablespoons.Had a long discussion w/ pt explaining to her the importance of following up w/ dr.(b)(6) for this issue.There is not a specialty wound dressing that i know that would be helpful to her.I think it¿s important to keep this draining so that she does not reform an abscess.Plan: use vashe on some gauze and clean it every day.Use gauze and abd pad to collect drainage.If it¿s striking through 50%, change it more than once a day.Will check on cultures.There would be an option to try her on some antibiotics even though i do not think that would be a final solution because of most likely colonized mesh that is still present in the pt.Needs to seek medical help right away if she has any fever or chills, increasing abdominal pain.I see our role being limited because of the intra-abdominal process.Addendum: culture of draining sinus tract grew out light growth of staphylococcus aureus sensitive to everything.Has anaphylaxis to keflex.Can tolerate other medicines and has been on doxycycline in the past w/o problems.Talked to pt about treating her or not treating.I think this is related to contaminated mesh left behind in her abdomen.She is draining fair amount of green-yellowish discharge.When i saw her last, she did not have any fever.There was no tenderness.Pt is doing okay, stated nothing has really changed.When i explained to her pros and cons of treatment, she opted to try treatment & i concur.Will treat w/ doxycycline.Asked to see her back (b)(6) 2001 to see how things are looking.(b)(6) 2017: (b)(6) hospital.Lab results.Abdominal surgical culture.Final gram stain: moderate polymorphonuclear wbcs.Rare gram positive cocci in pairs.Final surgical culture: staphylococcus aureus, light growth.Methicillin resistant? no.No anerobic bacteria isolated from culture.(b)(6) 2017: (b)(6) hospital.(b)(6) , md.Wound clinic progress note.Has been using vashe as a wound cleanser twice a day using gauze to bring forth the drainage.I did culture out mrsa.Finished doxycycline about a week ago.Only change noticed was color of drainage changed from dark green to lighter green-yellow.Has not had any fever or chills.A couple times a week she will get up to a level 7/10 discomfort in the middle of night that may last for about an hour, although last night it lasted a couple of hours.Does not have any tenderness on her skin where the wound [is].Seems to be insensate in that region, probably related to all the scar tissue.Has not been vomiting.Ct scan on (b)(6) 2003 concluded there was evidence of soft tissue inflammation, straining associated w/ inferior aspect of mesh shows interval improvement.No definable abscess.Overall it showed improvement from may.Belly is soft, nontender.I do not feel any suggestion of any abscess w/ palpation around the wound.There is no foul odor.Discharge noted on gauze was yellowish color.Draining probably about a tablespoon or more twice daily.Changes it once a day i believe.It is not healthy granulation tissue at the base of the wound.Does bleed through.There is some granulation tissue and there is some fibrin to the base of the wound.Periwound does not look infected at all.You can feel the scar tissue, feels firm and has poor skin turgor.This was located just above the umbilicus.No tenderness in right or left upper quadrant.I do note a skin graft over the sternal region.We then cleansed this w/ some vashe and then dressed it w/ some gauze and tape to be changed twice daily or more often if needed.Assessment: has wound that seems to be expanding slightly, length by width.She really did not respond i do not think to the antibiotics of 10 days of doxycycline for the mrsa.Plan: i would not continue antibiotics, it would just probably breed resistance.I think this is a deeper problem that probably will not respond to prolonged antibiotics.I recommended she clean it 2 times a day and change it w/ gauze to keep it draining so it does not plug up and accumulate and potentially increase her risk for re-abscess formation.I have informed pt that i do not really have anything else to offer here at the wound clinic but i have strongly encouraged her to follow-up w/ dr.Brady.Pt discharged from wound clinic.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® 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.¿ the gore dualmesh® biomaterial instructions for use also states: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ 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: 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: (b)(6) 2017: (b)(6) center.(b)(6), md/ (b)(6), md.History and physical.History: irritable bowel.Surgical history: cholecystectomy with hysterectomy 1980.Meds: glyburide, aspirin, metformin.Exam: draining upper abdominal sinus, purulent, no surrounding cellulitis.Likely had gerd (b)(6) 2010.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® dualmesh® 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® dualmesh® 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.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: 10/??/2008: [missing records: records for operative report for ¿wound closure for mediastinitis (likely with open omental harvest and split thickness skin graft)¿ were not provided.] 03/??/2009: [missing records: records for operative report for ¿open ventral hernia repair with primary closure¿ were not provided.06/??/2009: [missing records: records for operative report for ¿laparoscopic ventral hernia repair¿ were not provided.] (b)(6) 2010: [ni].(b)(6), md.History & physical.Recurrent ventral/incisional hernia.History: complex surgical history stemming from a coronary artery bypass graft with what sounds like mediastinitis and need for wound closure.Appears patient had an open omental flap followed by development of a hernia requiring open repair which failed and then laparoscopic repair.Last operation (b)(6) 2009.States (b)(6) 2009 she noted a lump and discomfort in region of upper abdomen.Has since enlarged and has persistent discomfort.Ct scan revealed findings consistent with a hernia and seroma; referred for further evaluation.Describes intermittent solid food dysphagia, episodic and at times associated with nausea and vomiting.Denies abdominal distention or change in bowel or bladder dysfunction.Surgical history: ectopic pregnancy 1975, debridement of mediastinitis 07/08 and 09/08, wound closure for mediastinitis 10/08 (likely with open omental harvest and split thickness skin graft), open ventral hernia repair with primary closure 03/09, laparoscopic ventral hernia repair 06/09.Medications: aspirin.Smoker; a pack per week; smoking for 40 years.Weight 285, bmi 50.5.Chest: reveals wide midline wound that appears to be a skin graft.At lower chest in the midline at the junction of the abdomen is a mass that is soft, reducible and tender.Caudal to this is a lower midline abdominal incision.Abdomen: soft, nontender, without mass.Does have a pannus.Ct (b)(6) 2009 reveals findings consistent with what appears to represent an omental flap.Fluid collection beneath the mesh.Impression: appears to have a paraomental hernia adjacent to a previously placed mesh that has pulled away from the abdominal wall/diaphragm.Obesity with bmi over 50.Plan: will be seen today by dr.(b)(6) regarding candidacy for bariatric surgery for gastric band or bypass.If opts for a band then concurrent hernia repair can be performed.Would likely require amputation of the omental pedicle to avoid further recurrence.If patient opts for gastric bypass this would be done first followed by hernia repair after weight loss.(b)(6) 2014: (b)(6) surgery, pa.(b)(6), md.Office notes.Consult abdominal pain and possible recurrent abdominal wall hernia.Impression: abdominal pain in setting of multiple prior hernia repairs.Could represent another hernia versus inflammation of abdominal wall scar.Morbid obesity.Plan: ct abdomen/pelvis; further plans pending ct scan.Recommend working with primary care physician on weight loss.Pain duration 1 month, right upper quadrant, is intermittent.Aggravating factors exertion, initially felt it after lifting.Bowel, bladder function unchanged.Weight 282 lbs., bmi 46.56.Gastrointestinal: soft, nondistended, well healed surgical scar in midline, focal tenderness and subtle fullness in right mid upper abdomen.(b)(6) 2015: (b)(6) casco bay.(b)(6), md.Telephone encounter.Ct from (b)(6) 2014 reviewed and discussed with patient.Postoperative changes including prior meshes, a chronic seroma, residual omental pedicle and affiliated scar/inflammation noted.No evidence of hernia, infection or intra-abdominal process.Follow up as needed.(b)(6) 2015: (b)(6) surgery, pa.(b)(6), md.Office notes.Postoperative follow up.3 weeks status post mesh explantation and wound debridement and vac placement.Overall doing well without evidence of infection.Pain improving, wound healing well.Continue vac dressing.Notes mild discomfort in region of wound, primarily with vac changes.Denies fever, chills, nausea or vomiting, bowel or bladder dysfunction.Gastrointestinal: soft, nondistended.8 cm t x 5 cm l x < 1 cm d granulating wound.No odor or discharge.(b)(6) 2015: (b)(6) casco bay.(b)(6); (b)(6), md.Telephone encounter.Caller: (b)(6) vn.Wondering if she can discontinue vac on monday or friday.Wound looks great, tunnels healed.Measurements 3.5 cm l x 7.5 cm w x 0.5 cm d.Would like to replace with aquacel ag.Action: ok.(b)(6) 2015: (b)(6) casco bay.(b)(6) ; (b)(6), md.Telephone encounter.Caller: (b)(6) vn.Wound looking great, drainage decreased significantly.Still using aquacell ag with foam; wondering if she could change dressing to every other day.Taught patient how to do dressing change; nurse will go twice a week to check wound.Measurements 3 cm l x 6 cm w x 0.1 d.Action: ok.(b)(6) 2016: (b)(6).(b)(6) ; (b)(6), md.Telephone encounter.Caller: (b)(6) rn.Wound looking good, drainage starting to decrease; bloody and serous drainage.10/12 measurements 12.2 l x 9 w x 6.5 d.Had a tunnel at 9 o¿clock of 4.5.10/17 measurements 12 l x 8 w x 5.Tunnel at 9 o¿clock is 3.8; tunnel is wide, able to tuck black foam in there which is working.Wants to know thought on changing to white foam in tunnel.Action: ok.(b)(6) 2016: (b)(6) casco bay.(b)(6); (b)(6), md.Telephone encounter.Caller: (b)(6) rn.Using white foam now in tunnel.Wondering if you want pressure turned up; currently at 125, wants to change to 150.At 2¿oclock there is part of wound that is not granulating up; used white foam in this as well.Action: keep at 125.(b)(6) 2016: (b)(6) surgery, pa.(b)(6), md.Office notes.3 weeks status post mesh explantation and wound debridement and vac placement.Overall doing well without evidence of infection.Pain improving, wound healing well.Treatment: continue vac.Follow up 6 weeks.Notes mild discomfort in the region at night and with vac changes.Denies fever, chills, nausea, vomiting, bowel or bladder dysfunction.Gastrointestinal: soft, bowel sounds present, nondistended.Vac removed revealing 9 cm l x 6 cm t x 4 cm d granulating tissue.Vac replaced.(b)(6) 2016: (b)(6).(b)(6); (b)(6), md.Telephone encounter.Caller: (b)(6) rn.Tunnel now ½ cm deep; going to discontinue white foam and just use black.Turned pressure down to 125.Needs verbal order.Action: ok.(b)(6) 2016: (b)(6) casco bay.(b)(6) ; (b)(6), md.Telephone encounter.Caller: (b)(6) rn.Would like to discontinue vac, change to alginate every 2-3 days as needed.Will be teaching patient to do dressing change.Wound 5.5 cm (l) x 3.5 (w) x less than 1 cm (d).Tissue granulated up to surface.Right side of wound slightly higher than left.Action: ok.(b)(6) 2016: (b)(6).(b)(6); (b)(6), md.Telephone encounter.Caller: patient.2.5 months status post incision/drainage of abdominal abscess with mesh excision.Now having nausea when she eats, constipation to diarrhea.Incision looks great, no masses.Action: advise she sees her primary care physician.(b)(6) 2017: (b)(6) casco bay.(b)(6); (b)(6), md.Telephone encounter.Caller: (b)(6) rn.Would like to discharge from services where patient is doing dressing herself.Wound now 1.8 (l) cm x 1cm (w) x 0.1 (d).Action: noted.(b)(6) 2017: (b)(6) casco bay.(b)(6); (b)(6), md.Telephone encounter.Caller: dr.(b)(6).Reason: abdominal mass.Patient seen today and he would like to discuss mass that is just to left and abuts the incision, which is red, hard and warm to touch with drainage.States is more than he can handle up in strong.Action: ct scheduled.(b)(6) 2017: (b)(6) surgery, pa.(b)(6), md.Office notes.Consult abdominal mass and drainage.Open abdominal wall wound; likely abscess that spontaneously drained.No evidence of infection presently.Treatment: begin normal saline wet to dry dressings.Presents with red, hard, painful mass followed by drainage and resolution of symptoms.Still draining ¿tan¿ fluid.Has had prior exploration and mesh explantation for abscess and infected mesh.Duration 2 weeks.Located in mid abdomen.Ct scan from last week reviewed revealing inflammatory changes in region.Gastrointestinal: obese, soft, nondistended, wide but healed surgical scar midline.Focal 2 cm diameter x 2.5 cm deep region of granulation tissue with scant serous drainage.No mass, fluctuance, tenderness.(b)(6) 2017: (b)(6) surgery, pa.(b)(6), md.Office notes.3 week follow up abdominal wound.Open abdominal wall wound (primary), non healing but without evidence of infection.Not consistent with fistula, but can¿t rule out undrained collection or communication with mesh.Treatment: ct abdomen/pelvis; further recommendations, treatment plan pending results.Referral to wound clinic; evaluate and treat abdominal wound.Abdominal pain: duration 5 weeks total.No significant change since seen 3 weeks ago.Located in mid abdomen.Bladder, bowel function unchanged.No fever, chills.Gastrointestinal: focal 0.5 cm diameter x 3.0 cm deep region of granulation tissue with scant serous discharge.No mass, fluctuance, tenderness.(b)(6) 2017: (b)(6) surgery, pa.(b)(6), md.Office notes.Ct reviewed.Wound appears to track cephalad toward mesh.Doubt this will heal without mesh explantation.Spoke with patient.She¿s seen dr.Tingley at (b)(6) wound center.Will get that note, then discuss options.Reports no change since seen there.(b)(6) 2018: (b)(6) surgery, pa.(b)(6), md.Office notes.About 4 weeks status post laparoscopic mesh explantation.Overall doing well without evidence of infection.Midline wound has healed.Treatment: infected prosthetic mesh of abdominal wall: no further prescription.Open abdominal wall wound: no further prescription.Follow up as needed.Currently pain free, reports wound has healed.Notes scant drainage from one of the trocar sites that is improving.Denies fever, chills, nausea or vomiting, bowel or bladder dysfunction, redness from incisions.Gastrointestinal: obese, bowel sounds present, soft, nondistended.Midline wound healed.Left upper quadrant trocar site with 3 mm opening with scant serous drainage.No erythema.Other trocar incisions well approximated without erythema or discharge.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® dualmesh® 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® dualmesh® 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.
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Manufacturer Narrative
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H6: updated health effect: clinical code; h6: updated investigation findings; h6: updated investigation conclusions; h6: health effect impact code: f1903: device explantation; h6: health effect clinical code: e2316: foreign body reaction; e1906: unspecified infection; previous patient code(s) (1690, 1695, 1932, 1994, and 3191, appropriate term/code not available for ¿fat necrosis¿.¿the mesh was noted, to have ¿folded up and contracted and formed a ¿meshoma¿.And ¿painful abdominal mass¿) were reported, based on the original complaint.And are no longer applicable and/or not reportable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span (b)(6) 2007 through (b)(6) 2018.And not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial with holes and the gore® dualmesh® biomaterial.Medical records from (b)(6) 2012 through (b)(6) 2014 were not provided.Patient information: medical history: morbid obesity: on (b)(6) 2008, 300 lbs., bmi 53.1; on (b)(6) 2010, 285 lbs., bmi 50.5; on (b)(6) 2015, 287 lbs., bmi 50.9; on (b)(6) 2017, 292 lbs., bmi 51.8.Chronic obstructive pulmonary disease [copd], type ii diabetes, on (b)(6) 2016, metformin smoking: unknown date, 1 pack per day for 50 years.On (b)(6) 2008, ½ pack per day smoker; on (b)(6) 2009, smokes 1 pack daily; on (b)(6) 2010, 1 pack per week; smoking for 40 years; on (b)(6) 2016, current smoker; on (b)(6) 2017, quit smoking 8 months ago.Hypertension, sleep apnea, hypercholesterolemia.Gastroesophageal reflux disease [gerd]: on (b)(6) 2010, recurrent incisional hernia in epigastric area.Fluid collection beneath mesh; on (b)(6) 2014, hiatal hernia, mesh has irregular appearance, fluid density anterior to mesh; on (b)(6) 2015, chronic seroma, residual omental pedicle and affiliated scar/inflammation; on (b)(6) 2015, sinus tract from old mesh, fat necrosis, meshoma, chronic inflammatory change; on (b)(6) 2016, abdominal wall cellulitis with abdominal wall abscess to mesh with air-fluid level collection; on (b)(6) 2017, open abdominal wall wound; likely abscess that spontaneously drained, inflammatory changes; on (b)(6) 2017, infected prosthetic mesh, open abdominal wall wound.Prior surgical procedures: 1975, ectopic pregnancy; 1980, cholecystectomy with hysterectomy; 2008, coronary artery bypass graft [cabg], incisional hernia repair with mesh, complicated by wound infection, multiple wound debridements; 2008-2009, hernia repair x 5; on (b)(6) 2008, open wound in chest hernia.Treated with 4 or 5 debridement procedures.And attempt of hernia repair; 9/08, debridement of mediastinitis; on(b)(6) 2008, wound closure for mediastinitis (likely with open omental harvest and split thickness skin graft); 3/09, open ventral hernia repair with primary closure.Relevant medical information: (on b)(6) 2007, ct abdomen/pelvis.¿hematoma within right rectus at level of pelvis.Intraperitoneal hematoma along right lateral aspect of low abdomen & pelvis¿.Implant #1 preoperative complaints: on (b)(6) 2009, ¿history of cabg with wound infection status post skin graft.Subsequently, developed ventral hernia.And underwent ventral hernia repair earlier this year.Has complained of recurrent ventral hernia enlargement¿.Implant #1 procedure: laparoscopic recurrent ventral hernia repair with mesh implantation; implant: gore® dualmesh® plus biomaterial with holes [1dlmcph08/(b)(6)] 26 cm x 34 cm, oval.Implant #1 date: (b)(6) 2009.Description of hernia being treated: ¿incision was made in the right abdominal wall lateral to the midclavicular line.Dissection was carried down bluntly through subcutaneous tissue until the fascia was reached.And sharply incised into and a balloon trocar was inserted.At this point, we identified a large subxiphoid ventral hernia with involvement of the small bowel and omentum.Using endoshears, we proceeded to take down the adhesions.Following extensive lysis of adhesions, the small bowel was dissected free.At this point, the omentum that was trapped in the ventral hernia was inspected.Due to her prior skin graft, it was decided, that the omentum would be left in place to provide blood flow to the skin graft.Inspection of the omentum, we were able to identify 2 large vessels supplying this portion of the omentum and preserved this vasculature¿.Implant size and fixation: ¿at this point, with the lysis of adhesions complete, we proceeded to place a dualmesh plus of 34 x 26 in size for our hernia repair.First, the mesh was prepared with gore sutures and was introduced into the abdomen.Once this was accomplished, it was unrolled intraabdominally and anchored to the abdominal wall in the superior, inferior, and in bilateral positions with the use of a carter-thomason suture-passing device.Once the mesh was anchored in these positions, a series of anchors placed with the protacker was placed along the border of the mesh.Additional, anchor sutures were placed with gore sutures in between the previously placed anchor sutures.Once all of these were completed, final inspection demonstrated no evidence of active bleeding or evidence of bowel injury.At this point, the abdomen was desufflated.Using o vicryl stitches, the balloon trocar port site was reapproximated.The fascia for the balloon trocar port site was reapproximated using a series of figure-of-eight stitches.The skin was reapproximated at all port incisions with 4-0 monocryl subcuticular stitches.Additionally, the stab wounds required for the placement of our anchor sutures were reapproximated¿.Relevant medical information: on (b)(6) 2009, ct chest/abdomen.¿seroma adjacent to anterior abdominal wall hernia mesh.Hernia defect superior to mesh extending into anterior chest wall¿.Implant #2 preoperative complaints: on (b)(6) 2010, ¿recurrent ventral/incisional hernia.Since (b)(6) 2009, noted a lump and discomfort in upper abdomen.Has since enlarged.And has persistent discomfort.Appears to have a paraomental hernia adjacent to a previously placed mesh, that has pulled away from the abdominal wall/diaphragm¿; on (b)(6) 2010, indications: ¿the patient presents with a history, exam, ct scan consistent with a paraomental hernia, following prior omental flap for sternal wound dehiscence.She has had two failed repair.And is admitted now with a history and exam consistent with incarcerating stomach and obstruction¿.Implant #2 procedure: extensive laparoscopic lysis of adhesions.Repair of paraomental (combination of ventral incisional and diaphragmatic) hernia laparoscopically.Placement of mesh for hernia repair.Implant: gore® dualmesh® biomaterial [1dlmc03/7225059] 10 cm x 15 cm, oval.Implant #2 date: (b)(6) 2010 (hospitalization (b)(6) 2010) description of hernia being treated: ¿local anesthesia was instilled.And a left subcostal incision was created with an 11 blade.A 5-mm optical trocar was inserted into the peritoneal cavity.And co2 insufflated to create a pneumoperitoneum to 12 mmhg pressure.A 5-mm, 30-degree laparoscope was inserted confirming, atraumatic intraperitoneal trocar placement, as well as extensive adhesions.Under direct visualization after local anesthesia and small skin incision, an infraumbilical 5-mm trocar was placed.And another 5-mm trocar was placed in the right upper abdomen laterally.This was later, upsized to a 12-mm trocar to accommodate the mesh.The scope was relocated to the umbilical trocar to facilitate triangulation and extensive adhesiolysis was carried out sharply.There were multiple loops of bowel adherent to the anterior abdominal wall.Fortunately, these adhesions were for the most part relatively flimsy and were able to be taken down safely.The bowel was examined carefully after adhesiolysis to be sure there was no enterotomy.After adhesiolysis, exposure to the hernia was achieved.And it was noted, that the distal stomach and proximal duodenum were within the defect.With the combination of internal manipulation and external palpation bluntly, the contents were reduced.What remained was the omental pedicle.It was felt appropriate to divide this in order to more definitively repair the hernia defect.The harmonic scalpel was used to divide the omental pedicle at the level of the hernia defect and this region was hemostatic¿.Implant size and fixation: ¿the defect was measured intracorporeally and was found to be just under 3 cm in diameter.Subsequently, a 10 cm diameter circular gore-tex dualmesh was felt appropriate to provide wide coverage with an overlap of greater than 3 cm circumferentially.The mesh was prepared extracorporeally by placing 0 ethibond sutures at the 3, 6, and 9 o¿clock positions and then was rolled up and inserted into the peritoneal cavity via the 12-mm trocar.Once positioned intraperitoneally, the mesh was secured initially at the 12 o¿clock position with intracorporeal suture of 0 ethibond to the diaphragm.The remaining three sutures were then pulled up through the anterior abdominal wall using the suture passer with a 1 cm fascial bridge at each site.Of note, during the first attempt using the gore suture passer, the tip of the gore suture passer broke off in the deep subcutaneous tissue, likely at the junction of the old mesh.This could not be easily located.And since it was within the deep subcutaneous tissue and probably lodged within the old mesh and not intraperitoneal, was not felt necessary to further pursue localization of this.Especially as it was felt highly unlikely that this would be identified.Following this, multiple 0 ethibond interrupted sutures were used to secure the mesh to the diaphragm from the 9-12 o¿clock position and the 12-3 o¿clock positions.The 5-mm hernia tacks were used to secure the mesh from the 3-6 o¿clock positions and 6-9 o¿clock positions.This essentially was overlapping the previously placed mesh.Upon completion, the tack and suture fixation sites were examined and were hemostatic.The 12-mm trocar was removed and this fascial defect approximated with a 0 ethibond, again placed using the suture passer.The remaining trocars were removed as the pneumoperitoneum was evacuated.All sites were hemostatic.The skin at the trocar sites was approximated with 4-0 vicryl subcuticular and dermabond.Dermabond alone was used for the mesh fixation sites¿.On (b)(6) 2010, incision remained clean and dry.Discharged with no heavy lifting.Relevant medical information: on (b)(6) 2014, ct abdomen/pelvis.¿presence of a large relatively well-defined fluid density structure immediately adjacent/posterior to the abdominal mesh within the subcutaneous fat plane with inflammatory changes¿; on (b)(6) 2015, ct abdomen.¿immediately adjacent/posterior to the abdominal wall mesh, there is a well defined fluid structure measuring 14 x 3 cm in sagittal dimension and 15 cm in transverse dimension¿.Conclusion: ¿phlegmon-like structure anterior to the abdominal wall mesh surrounded by inflammatory changes with interval worsening from (b)(6) 2014¿.Partial explant #1 [gore® dualmesh® biomaterial] preoperative complaints: on (b)(6) 2015, ¿abdominal pain in setting of multiple prior hernia repairs.No evidence of intra-abdominal process or recurrent hernia.Erythema last week, started on antibiotics without improvement.Ct abdomen repeated last week shows persistent (slightly smaller) fluid collection beneath the intraperitoneal gore-tex mesh.And increasing inflammatory changes in subcutaneous tissues, that does not clearly communicate with the gore-tex mesh.Abdomen with focal 8 cm diameter region of tenderness and fullness mid abdomen with blanching erythema¿; on (b)(6) 2015, indications: ¿this patient presents with an increasingly painful abdominal mass.Ct and clinical exam reveal, findings consistent with an inflammatory/infectious process within the subcutaneous tissue.The patient does have a history of multiple prior hernia repairs with mesh placement.And subsequently, it was felt that at least one of her underlying meshes was the nidus for this process.And exploration was felt appropriate and decided upon after discussion with the patient¿.Partial explant #1 [gore® dualmesh® biomaterial] procedure: abdominal exploration, debridement of skin and subcutaneous tissue, mesh explantation, vac dressing placement.Partial explant #1 [gore® dualmesh® biomaterial] date: (b)(6) 2015.On (b)(6) 2015, ¿sterile prep and drape was performed, local anesthesia was instilled, and a longitudinally oriented elliptical incision was created with a scalpel around the abnormal region.Electrocautery was used to divide the subcutaneous tissue and to create a ¿core¿ of tissue, that included the chronic inflammatory change.As this continued down to the abdominal wall, an obvious mesh prosthesis was encountered.This appeared to have folded up and contracted and formed a ¿meshoma¿.This was clearly contiguous with the process.And was felt to likely be the nidus of the process.This was able to be excised/explanted at the level of the abdominal wall.This was sent as a specimen.Of note, the specimen was later, opened on the back table and there was a clear sinus tract extending from the mesh to the skin with significant amount of what appeared to be fat necrosis and chronic granulation.This was sent for culture.Following this, the wound bed was examined.There was one area, where there was a small, 1 cm opening and with pressure, a large amount of serous fluid was returned.The preoperative ct scan did show a deep seroma.And this was felt to likely be fluid from the seroma.As this appeared to be contiguous with the deep mesh on ct scan, it was felt appropriate to send this for stat gram stain to rule out infection.This came back 1+ polys and no recognizable bacteria.Subsequently, it was not felt necessary to explore the deeper mesh.Which again could not be visualized, and did not appear to be contiguous with the current process.As much of the fluid as possible was evacuated, which was a total of approximately 200 ml.At this point, the wound was irrigated and was hemostatic.A vac dressing was placed¿.On (b)(6) 2015, brief note: ¿sinus track from old mesh up to nearly skin surface with fat necrosis.Fat necrosis sent for culture.Did not appear to freely communicate with the seroma known to be associated with the deepest mesh, but this was entered with gentle further probing, drained and sent for stat gram stain.Which was negative¿; on (b)(6) 2015, pathology.¿specimen, final diagnosis: skin and subcutaneous tissue, abdomen, excision: benign skin and subcutaneous tissue with acutely inflamed granulation tissue.Gross description: specimen is abdominal wound skin, subcutaneous tissue, sinus tract and old mesh.Specimen consists of a piece of fibrofatty tissue with embedded mesh material and attached slightly pigmented nodular skin.Measures 11.0 x 9.0 x 4.8 cm.Skin measures 9.0 x 3.0 cm.Mesh is embedded at the posterior aspect of the specimen.Sectioning shows a sinus tract extending from the mesh to the surface of the skin.The tract measures 6.0 cm in length with a diameter of 1.2 cm.It contains a bloody thick fluid¿.Relevant medical information: on (b)(6) 2015, ¿(b)(6) weeks status post mesh explantation.And wound debridement and vac placement.Overall doing well, without evidence of infection.Pain improving, wound healing well.Continue vac dressing¿; on (b)(6) 2016, ¿presents with a (b)(6) history of swelling, tenderness over the right mid to lower abdomen.Which came up quite suddenly.Assessment/plan: mass: suspected to be another intra-abdominal abscess.And/or atypical recurrence of a ventral hernia¿.On (b)(6) 2016, abdominal sonogram: ¿area of redness at right lower abdomen.Seroma noted, but abscess cannot be excluded at scar.Impression: cellulitis of abdominal wall¿.On (b)(6) 2016, ¿reports increasing abdominal discomfort, as well as an area around previous problems.With her cellulitic changes that now seems to be swelling and protruding.Assessment/plan: previously diagnosed abdominal wall cellulitis.Suspect an organizing abscess.Exquisitely tender and enlarging in size¿.On (b)(6) 2016, ultrasound abdomen-limited: ¿cellulitis with evidence of phlegmon.These are more prominent compared to (b)(6) 2016.Additionally, complicated seroma-like structure at or near the surgical scar shows an interval slight increase in size¿.On (b)(6) 2016, ct abdomen/pelvis: ¿new air-fluid level within fluid collection deep to the marlex mesh worrisome for abscess formation.Increase in size of the subjacent subcutaneous fluid collection anterior/superficial to the mesh.While there is no air-fluid level, an infectious process/abscess is suspected given the surrounding inflammatory changes.This could also represent hematoma¿.Explant #2 [gore® dualmesh® plus biomaterial with holes] preoperative complaints: on (b)(6) 2016, abdomen: ¿soft, right lower abdomen and pannus tender, 10x 8 cm area swelling.Induration, erythema without active drainage.Midline surgical wound is well healed without evidence of hernia or masses¿; on (b)(6) 2016, ¿history of previous mesh placement and previous mesh explantation for infected mesh.Presents with evidence of a subcutaneous collection consistent with subcutaneous abscess, as well as fluid in the retro mesh position.With also suspicious for infection in this region as well¿.Explant #2 [gore® dualmesh® plus biomaterial with holes] procedure: incision and drainage of subcutaneous abscess, debridement of necrotic subcutaneous fat, mesh explantation.Vac dressing placement.Explant #2 [gore® dualmesh® plus biomaterial with holes] date: (b)(6) 2016.(hospitalization (b)(6) 2016); on (b)(6) 2016: ¿a midline skin incision was created with a scalpel.Dissection was then carried down with electrocautery.And a large pus pocket was encountered at the midline and extending to the right of midline.This was evacuated.Culture was taken.Irrigation was performed.There was some necrotic fat surrounding this abscess cavity.Which was debrided using electrocautery and hemostasis assured.The midline fascia/scar was identified, and incised exposing the underlying gore-tex mesh.The mesh was incised and there was an obvious large collection of pus beneath this mesh.Which was evacuated.And also sent for culture.Using combination of sharp and blunt dissection, as well as electrocautery when needed.The mesh was dissected away from the overlying abdominal wall out to the perimeter.The perimeter, multiple sutures and tacks were identified.These were all removed allowing for complete explantation of the mesh.At the cephalad, aspect of the mesh was omentum going into the mediastinum which was intact.Underneath the mesh was an inflammatory rind.And there was no free peritoneal cavity or exposure of the viscera.The area was copiously irrigated.There were a few small bleeding points, that were controlled with a combination of electrocautery, as well as 3-0 vicryl suture ligatures.The region was measured at approximately 20 cm transversely x 15 cm longitudinally x 8 cm deep.Two separate vac sponges were placed with good seal and suction.The patient was then extubated uneventfully.And taken to pacu awake and in stable condition¿; on (b)(6) 2016, pathology: ¿specimen: a mesh for gross only.Final diagnosis: abdominal mesh, removal consistent with mesh (gross only).Gross description: consists of an irregular portion of tan synthetic material measuring 21 x 15 x 0.5 cm.Scant fibrous tissue is attached.Microbiology.Culture anaerobic and aerobic other specimen with stain.Result: no growth at 48 hours.Final report: no growth aerobically or anaerobically.Gram reaction result: 2+ pmn¿s [polymorphonuclear leukocytes], no recognizable bacteria seen¿.On (b)(6) 2016, discharge: ¿vac was draining around 200 ml of serosanguinous fluid on pod 2 and 3.Though no significant sources of bleeding were found on dressing change.Wound vac in place: wound granulating and healing appropriately¿.Relevant medical information: on (b)(6) 2016, ¿(b)(6) weeks status post mesh explantation.And wound debridement and vac placement.Overall doing well without evidence of infection¿; on (b)(6) 2017, ct abdomen & pelvis ¿significant improvement with resolution of previous abscess collection associated with the mesh.There is mild supraumbilical and umbilical soft tissue density and stranding¿; on (b)(6) 2017, ¿(b)(6) week follow up of open abdominal wall wound.Non healing, but without evidence of infection.Not consistent with fistula, but can¿t rule out undrained collection or communication with mesh.Referral to wound clinic¿; on (b)(6) 2017, ct abdomen/pelvis ¿evidence of soft-tissue inflammation/straining associated with inferior aspect of mesh shows interval improvement¿; on(b)(6) 2017, ¿has a massive belly.Wound above umbilicus.Sterile q-tip goes in gently up to about 0.7 cm.Some fibrous nonviable tissue that comes out of this wound.Culture of draining sinus tract grew out light growth of staphylococcus aureus sensitive to everything.May be related to contaminated mesh left behind in her abdomen¿; on (b)(6) 2017, ¿wound appears to track cephalad toward mesh.Doubt this will heal without mesh explantation¿; on (b)(6) 2017, ¿finished doxycycline about a week ago.Only change noticed was color of drainage changed from dark green to lighter green-yellow.Has wound, that seems to be expanding slightly, length by width.She really did not respond to the antibiotics of (b)(6) days of doxycycline for the mrsa¿; on (b)(6) 2017, ¿infected prosthetic mesh of abdominal wall.Open abdominal wall wound.Ct scan of the abdomen reveals, fluid collection tracing from the wound to around the previous microporous mesh¿.Explant #3 [gore® dualmesh® biomaterial] preoperative complaints: on (b)(6) 2017, ¿presents with a chronic abdominal wound.This is felt to likely be communicating with a previously placed mesh.And this process would not resolve without removal of the foreign body¿.Explant #3 [gore® dualmesh® biomaterial] procedure: diagnostic laparoscopy, extensive lysis of adhesions, mesh explantation.Explant #3 [gore® dualmesh® biomaterial] date: (b)(6) 2017.Procedure: ¿5 mm optical trocar was used to access the peritoneal cavity under direct visualization.And co2 then insufflated creating pneumoperitoneum to 12 mmhg pressure.5 minute [sic] of 30° left scope was inserted confirming, atraumatic intraperitoneal trocar placement.There were omental adhesions to the abdominal wall.Under direct visualization after local anesthesia and small skin incision, 2 more 5 mm trochars [sic] are placed.One in the midline infra umbilical region and another in the right upper quadrant.The original left upper quadrant trocar was later upsized to a 12 mm trocar to allow for extraction of the mesh.The scope was relocated to the infraumbilical trocar to facilitate regulation.Using combination of sharp and blunt dissection, as well as electrocautery when needed.Significant omental adhesions were taken down from the abdominal wall to facilitate exposure.This led to exposure of firm inflammatory capsule overlying the mesh.Using cautery.This was dissected off of the abdominal wall the previously, placed mesh and removed from the patient.The mesh was then dissected away from the abdominal wall.There are multiple previously placed titanium hernia tacks that were kept with the mesh and removed.There are also multiple ethibond sutures.Which were divided and removed as well.Care was taken to avoid injury to the diaphragm.After takedown of the mesh, the abdominal wall and omentum were examined.There was some purulent and fibrinous material identified.This was suctioned.The area was irrigated copiously.A final survey was taken.There was no active issue.There was no bleeding.An endo pouch bag was inserted via the left upper quadrant trocar and the mesh was placed within the bag.Which was then closed and removed.The fascial defect at this site was approximated with 0 vicryl figure of eight suture.Placed with the gore suture passer using left scopic [sic] assistance.A culture was taken of the mesh.Which was then sent to pathology along with the inflammatory capsule.The remaining trochars [sic] removed as the pneumoperitoneum was evacuated.All sites were hemostatic.The trocar sites were approximated with 4-0 vicryl subcuticular and dermabond¿; on (b)(6) 2017, pathology and cytology: ¿specimen: a) explanted mesh.B) inflammatory rind.Final diagnosis: a) explanted mesh, removal benign fibroconnective and adipose tissue with inflammation.Reactive changes and foreign body giant cells surrounding foreign material.B) soft tissue, inflammatory rind, biopsy: fibroconnective and adipose tissue with inflammation, reactive changes and foreign-body giant cells.Gross description: a) explanted mesh consists of an approximate 9.0 x 7.0 x 0.1 cm synthetic mesh with a small amount of adherent soft tissue.Microbiology.Culture and aerobic + aerobic result: no growth at 48 hours.No anaerobes isolated.Gram reaction: 2+ pmn¿s, 2+ gram positive cocci in clusters¿.Relevant medical information: (b)(6) 2018, (b)(6) weeks status post laparoscopic mesh explantation.Overall doing well without evidence of infection.Midline wound has healed.Notes scant drainage from one of the trocar sites that is improving.Left upper quadrant trocar site with 3 mm opening with scant serous drainage.Conclusion: gore® dualmesh® biomaterial (7225059/1dlmc03).It should be noted, that the gore® dualmesh® 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¿.The instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material¿.Procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.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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Manufacturer Narrative
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H6: health effect impact code: f1903: device explantation.H6: medical device component: g07001: part/component/sub-assembly term not applicable.Previous patient code(s) (1690, 1695, 1932, 1994, and 3191: appropriate term/code not available for ¿fat necrosis¿, ¿the mesh was noted to have ¿folded up and contracted and formed a ¿meshoma¿¿ and ¿painful abdominal mass¿) were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The investigation has been completed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.Medical records: the known medical records span june 7, 2007 through january 8, 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial with holes and the gore® dualmesh® biomaterial.Medical records from september 13, 2012 through november 25, 2014 were not provided.Patient information: medical history: ¿ morbid obesity (b)(6) 2008: 300 lbs., bmi 53.1.(b)(6) 2010: 285 lbs., bmi 50.5.(b)(6) 2015: 287 lbs., bmi 50.9.(b)(6) 2017: 292 lbs., bmi 51.8.Chronic obstructive pulmonary disease [copd].Type ii diabetes" (b)(6) 2016: metformin.Smoking: unknown date: 1 pack per day for 50 years.(b)(6) 2008: ½ pack per day smoker.(b)(6) 2009: smokes 1 pack daily.(b)(6) 2010: 1 pack per week; smoking for 40 years.(b)(6) 2016: current smoker.(b)(6) 2017: quit smoking 8 months ago.Hypertension.Sleep apnea.Hypercholesterolemia.Gastroesophageal reflux disease [gerd]: (b)(6) 2010: recurrent incisional hernia in epigastric area.Fluid collection beneath mesh.(b)(6) 2014: hiatal hernia, mesh has irregular appearance, fluid density anterior to mesh.(b)(6) 2015: chronic seroma, residual omental pedicle and affiliated scar/inflammation.(b)(6) 2015: sinus tract from old mesh, fat necrosis, meshoma, chronic inflammatory change.(b)(6) 2016: abdominal wall cellulitis with abdominal wall abscess to mesh with air-fluid level collection.(b)(6) 2017: open abdominal wall wound; likely abscess that spontaneously drained, inflammatory changes.(b)(6) 2017: infected prosthetic mesh, open abdominal wall wound.Prior surgical procedures: 1975: ectopic pregnancy.1980: cholecystectomy with hysterectomy.2008: coronary artery bypass graft [cabg], incisional hernia repair with mesh, complicated by wound infection, multiple wound debridements.2008-2009: hernia repair x 5.(b)(6) 2008: open wound in chest hernia; treated with 4 or 5 debridement procedures and attempt of hernia repair.(b)(6) 2008: debridement of mediastinitis.(b)(6) 2008: wound closure for mediastinitis (likely with open omental harvest and split thickness skin graft).(b)(6) 2009: open ventral hernia repair with primary closure.Relevant medical information: (b)(6) 2007: ct abdomen/pelvis.¿hematoma within right rectus at level of pelvis.Intraperitoneal hematoma along right lateral aspect of low abdomen & pelvis.¿ implant #1 preoperative complaints: (b)(6) 2009: ¿history of cabg with wound infection status post skin graft.Subsequently developed ventral hernia and underwent ventral hernia repair earlier this year.Has complained of recurrent ventral hernia enlargement.¿ implant #1 procedure: laparoscopic recurrent ventral hernia repair with mesh implantation.Implant: gore® dualmesh® plus biomaterial with holes [1dlmcph08/05803916] 26 cm x 34 cm, oval.Implant #1 date: (b)(6) 2009: description of hernia being treated: ¿incision was made in the right abdominal wall lateral to the midclavicular line.Dissection was carried down bluntly through subcutaneous tissue until the fascia was reached and sharply incised into and a balloon trocar was inserted.At this point, we identified a large subxiphoid ventral hernia with involvement of the small bowel and omentum.Using endoshears, we proceeded to take down the adhesions.Following extensive lysis of adhesions, the small bowel was dissected free.At this point, the omentum that was trapped in the ventral hernia was inspected.Due to her prior skin graft, it was decided that the omentum would be left in place to provide blood flow to the skin graft.Inspection of the omentum, we were able to identify 2 large vessels supplying this portion of the omentum and preserved this vasculature.¿ implant size and fixation: ¿at this point, with the lysis of adhesions complete, we proceeded to place a dualmesh plus of 34 x 26 in size for our hernia repair.First, the mesh was prepared with gore sutures and was introduced into the abdomen.Once this was accomplished, it was unrolled intraabdominally and anchored to the abdominal wall in the superior, inferior, and in bilateral positions with the use of a carter-thomason suture-passing device.Once the mesh was anchored in these positions, a series of anchors placed with the protacker was placed along the border of the mesh.Additional anchor sutures were placed with gore sutures in between the previously placed anchor sutures.Once all of these were completed, final inspection demonstrated no evidence of active bleeding or evidence of bowel injury.At this point, the abdomen was desufflated.Using o vicryl stitches, the balloon trocar port site was reapproximated.The fascia for the balloon trocar port site was reapproximated using a series of figure-of-eight stitches.The skin was reapproximated at all port incisions with 4-0 monocryl subcuticular stitches.Additionally, the stab wounds required for the placement of our anchor sutures were reapproximated.¿ relevant medical information: (b)(6) 2009: ct chest/abdomen.¿seroma adjacent to anterior abdominal wall hernia mesh.Hernia defect superior to mesh extending into anterior chest wall.¿ implant #2 preoperative complaints: (b)(6) 2010: ¿recurrent ventral/incisional hernia.Since (b)(6) 2009, noted a lump and discomfort in upper abdomen.Has since enlarged and has persistent discomfort.Appears to have a paraomental hernia adjacent to a previously placed mesh that has pulled away from the abdominal wall/diaphragm.¿ (b)(6) 2010: indications: ¿the patient presents with a history, exam, ct scan consistent with a paraomental hernia following prior omental flap for sternal wound dehiscence.She has had two failed repair and is admitted now with a history and exam consistent with incarcerating stomach and obstruction.¿ implant #2 procedure: extensive laparoscopic lysis of adhesions.Repair of paraomental (combination of ventral incisional and diaphragmatic) hernia laparoscopically.Placement of mesh for hernia repair.Implant: gore® dualmesh® biomaterial [1dlmc03/7225059] 10 cm x 15 cm, oval; gore® suture passer (unk/unk).Implant #2 date: (b)(6) 2010 (hospitalization (b)(6) 2010).Description of hernia being treated: ¿local anesthesia was instilled and a left subcostal incision was created with an 11 blade.A 5-mm optical trocar was inserted into the peritoneal cavity and co2 insufflated to create a pneumoperitoneum to 12 mmhg pressure.A 5-mm 30-degree laparoscope was inserted confirming atraumatic intraperitoneal trocar placement as well as extensive adhesions.Under direct visualization after local anesthesia and small skin incision, an infraumbilical 5-mm trocar was placed and another 5-mm trocar was placed in the right upper abdomen laterally.This was later upsized to a 12-mm trocar to accommodate the mesh.The scope was relocated to the umbilical trocar to facilitate triangulation and extensive adhesiolysis was carried out sharply.There were multiple loops of bowel adherent to the anterior abdominal wall.Fortunately, these adhesions were for the most part relatively flimsy and were able to be taken down safely.The bowel was examined carefully after adhesiolysis to be sure there was no enterotomy.After adhesiolysis, exposure to the hernia was achieved and it was noted that the distal stomach and proximal duodenum were within the defect.With the combination of internal manipulation and external palpation bluntly, the contents were reduced.What remained was the omental pedicle.It was felt appropriate to divide this in order to more definitively repair the hernia defect.The harmonic scalpel was used to divide the omental pedicle at the level of the hernia defect and this region was hemostatic.¿ implant size and fixation: ¿the defect was measured intracorporeally and was found to be just under 3 cm in diameter.Subsequently, a 10 cm diameter circular gore-tex dualmesh was felt appropriate to provide wide coverage with an overlap of greater than 3 cm circumferentially.The mesh was prepared extracorporeally by placing 0 ethibond sutures at the 3, 6, and 9 o¿clock positions and then was rolled up and inserted into the peritoneal cavity via the 12-mm trocar.Once positioned intraperitoneally, the mesh was secured initially at the 12 o¿clock position with intracorporeal suture of 0 ethibond to the diaphragm.The remaining three sutures were then pulled up through the anterior abdominal wall using the suture passer with a 1 cm fascial bridge at each site.Of note, during the first attempt using the gore suture passer, the tip of the gore suture passer broke off in the deep subcutaneous tissue, likely at the junction of the old mesh.This could not be easily located and since it was within the deep subcutaneous tissue and probably lodged within the old mesh and not intraperitoneal, was not felt necessary to further pursue localization of this, especially as it was felt highly unlikely that this would be identified.Following this, multiple 0 ethibond interrupted sutures were used to secure the mesh to the diaphragm from the 9-12 o¿clock position and the 12-3 o¿clock positions.The 5-mm hernia tacks were used to secure the mesh from the 3-6 o¿clock positions and 6-9 o¿clock positions.This essentially was overlapping the previously placed mesh.Upon completion, the tack and suture fixation sites were examined and were hemostatic.The 12-mm trocar was removed and this fascial defect approximated with a 0 ethibond, again placed using the suture passer.The remaining trocars were removed as the pneumoperitoneum was evacuated.All sites were hemostatic.The skin at the trocar sites was approximated with 4-0 vicryl subcuticular and dermabond.Dermabond alone was used for the mesh fixation sites.¿ (b)(6) 2010: incision remained clean and dry.Discharged with no heavy lifting.Relevant medical information: (b)(6) 2014: ct abdomen/pelvis.¿presence of a large relatively well-defined fluid density structure immediately adjacent/posterior to the abdominal mesh within the subcutaneous fat plane with inflammatory changes.¿ (b)(6) 2015: ct abdomen.¿immediately adjacent/posterior to the abdominal wall mesh there is a well defined fluid structure measuring 14 x 3 cm in sagittal dimension and 15 cm in transverse dimension.¿ conclusion: ¿phlegmon-like structure anterior to the abdominal wall mesh surrounded by inflammatory changes with interval worsening from (b)(6) 2014.¿ partial explant #1 [gore® dualmesh® biomaterial] preoperative complaints: (b)(6) 2015: ¿abdominal pain in setting of multiple prior hernia repairs.No evidence of intra-abdominal process or recurrent hernia.Erythema last week, started on antibiotics without improvement.Ct abdomen repeated last week shows persistent (? slightly smaller) fluid collection beneath the intraperitoneal gore-tex mesh and increasing inflammatory changes in subcutaneous tissues that does not clearly communicate with the gore-tex mesh.Abdomen with focal 8 cm diameter region of tenderness and fullness mid abdomen with blanching erythema.¿ (b)(6) 2015: indications: ¿this patient presents with an increasingly painful abdominal mass.Ct and clinical exam reveal findings consistent with an inflammatory/infectious process within the subcutaneous tissue.The patient does have a history of multiple prior hernia repairs with mesh placement and subsequently it was felt that at least one of her underlying meshes was the nidus for this process and exploration was felt appropriate and decided upon after discussion with the patient.¿ partial explant #1 [gore® dualmesh® biomaterial] procedure: abdominal exploration.Debridement of skin and subcutaneous tissue.Mesh explantation.Vac dressing placement.Partial explant #1 [gore® dualmesh® biomaterial] date: (b)(6) 2015: (b)(6) 2015: ¿sterile prep and drape was performed, local anesthesia was instilled, and a longitudinally oriented elliptical incision was created with a scalpel around the abnormal region.Electrocautery was used to divide the subcutaneous tissue and to create a ¿core¿ of tissue that included the chronic inflammatory change.As this continued down to the abdominal wall, an obvious mesh prosthesis was encountered.This appeared to have folded up and contracted and formed a ¿meshoma.¿ this was clearly contiguous with the process and was felt to likely be the nidus of the process.This was able to be excised/explanted at the level of the abdominal wall this was sent as a specimen.Of note, the specimen was later opened on the backtable and there was a clear sinus tract extending from the mesh to the skin with significant amount of what appeared to be fat necrosis and chronic granulation.This was sent for culture.Following this, the wound bed was examined.There was one area where there was a small, 1 cm opening and with pressure, a large amount of serous fluid was returned.The preoperative ct scan did show a deep seroma and this was felt to likely be fluid from the seroma.As this appeared to be contiguous with the deep mesh on ct scan, it was felt appropriate to send this for stat gram stain to rule out infection.This came back 1+ polys and no recognizable bacteria.Subsequently, it was not felt necessary to explore the deeper mesh, which again could not be visualized and did not appear to be contiguous with the current process.As much of the fluid as possible was evacuated, which was a total of approximately 200 ml.At this point, the wound was irrigated and was hemostatic.A vac dressing was placed.¿ (b)(6) 2015: brief note: ¿sinus track from old mesh up to nearly skin surface with fat necrosis.Fat necrosis sent for culture.Did not appear to freely communicate with the seroma known to be associated with the deepest mesh, but this was entered with gentle further probing, drained and sent for stat gram stain, which was negative.¿ (b)(6) 2015: pathology.¿specimen: final diagnosis: skin and subcutaneous tissue, abdomen, excision: benign skin and subcutaneous tissue with acutely inflamed granulation tissue.Gross description: specimen is abdominal wound skin, subcutaneous tissue, sinus tract and old mesh.Specimen consists of a piece of fibrofatty tissue with embedded mesh material and attached slightly pigmented nodular skin.Measures 11.0 x 9.0 x 4.8 cm.Skin measures 9.0 x 3.0 cm.Mesh is embedded at the posterior aspect of the specimen.Sectioning shows a sinus tract extending from the mesh to the surface of the skin.The tract measures 6.0 cm in length with a diameter of 1.2 cm.It contains a bloody thick fluid.¿ relevant medical information: (b)(6) 2015: ¿three weeks status post mesh explantation and wound debridement and vac placement.Overall doing well without evidence of infection.Pain improving, wound healing well.Continue vac dressing.¿ (b)(6) 2016: ¿presents with a 24-hr history of swelling, tenderness over the right mid to lower abdomen which came up quite suddenly.Assessment/plan: mass: suspected to be another intra-abdominal abscess and/or atypical recurrence of a ventral hernia.¿ (b)(6) 2016: abdominal sonogram: ¿area of redness at right lower abdomen.Seroma noted, but abscess cannot be excluded at scar.Impression: cellulitis of abdominal wall.¿ (b)(6) 2016: ¿reports increasing abdominal discomfort, as well as an area around previous problems with her cellulitic changes that now seems to be swelling and protruding.Assessment/plan: previously diagnosed abdominal wall cellulitis.Suspect an organizing abscess.Exquisitely tender and enlarging in size.¿ (b)(6) 2016: ultrasound abdomen-limited: ¿cellulitis with evidence of phlegmon; these are more prominent compared to (b)(6) 2016.Additionally, complicated seroma-like structure at or near the surgical scar shows an interval slight increase in size.¿ (b)(6) 2016: ct abdomen/pelvis: ¿new air-fluid level within fluid collection deep to the marlex mesh worrisome for abscess formation.Increase in size of the subjacent subcutaneous fluid collection anterior/superficial to the mesh.While there is no air-fluid level, an infectious process/abscess is suspected given the surrounding inflammatory changes.This could also represent hematoma.¿ explant #2 [gore® dualmesh® plus biomaterial with holes] preoperative complaints: (b)(6) 2016: abdomen: ¿soft, right lower abdomen and pannus tender, ~10x 8 cm area swelling, induration, erythema without active drainage.Midline surgical wound is well healed without evidence of hernia or masses.¿ (b)(6) 2016: ¿history of previous mesh placement and previous mesh explantation for infected mesh.Presents with evidence of a subcutaneous collection consistent with subcutaneous abscess as well as fluid in the retro mesh position with also suspicious for infection in this region as well.¿ explant #2 [gore® dualmesh® plus biomaterial with holes] procedure: incision and drainage of subcutaneous abscess.Debridement of necrotic subcutaneous fat.Mesh explantation.Vac dressing placement.Explant #2 [gore® dualmesh® plus biomaterial with holes] date: (b)(6) 2016 (hospitalization (b)(6) 2016) (b)(6) 2016: ¿a midline skin incision was created with a scalpel.Dissection was then carried down with electrocautery and a large pus pocket was encountered at the midline and extending to the right of midline.This was evacuated.Culture was taken.Irrigation was performed.There was some necrotic fat surrounding this abscess cavity which was debrided using electrocautery and hemostasis assured.The midline fascia/scar was identified and incised exposing the underlying gore-tex mesh.The mesh was incised and there was an obvious large collection of pus beneath this mesh which was evacuated and also sent for culture.Using combination of sharp and blunt dissection as well as electrocautery when needed, the mesh was dissected away from the overlying abdominal wall out to the perimeter.The perimeter, multiple sutures and tacks were identified.These were all removed allowing for complete explantation of the mesh.At the cephalad aspect of the mesh was omentum going into the mediastinum which was intact.Underneath the mesh was an inflammatory rind and there was no free peritoneal cavity or exposure of the viscera.The area was copiously irrigated.There were a few small bleeding points that were controlled with a combination of electrocautery as well as 3-0 vicryl suture ligatures.The region was measured at approximately 20 cm transversely x 15 cm longitudinally x 8 cm deep.Two separate vac sponges were placed with good seal and suction.The patient was then extubated uneventfully and taken to pacu awake and in stable condition.¿ (b)(6) 20 16: pathology: ¿specimen: a) mesh for gross only.Final diagnosis: abdominal mesh, removal: consistent with mesh (gross only).Gross description: consists of an irregular portion of tan synthetic material measuring 21 x 15 x 0.5 cm.Scant fibrous tissue is attached.Microbiology.Culture anaerobic and aerobic other specimen with stain.Result: no growth at 48 hours.Final report: no growth aerobically or anaerobically.Gram reaction result: 2+ pmn¿s [polymorphonuclear leukocytes], no recognizable bacteria seen.¿ (b)(6) 2016: discharge: ¿vac was draining around 200 ml of serosanguinous fluid on pod 2 and 3, though no significant sources of bleeding were found on dressing change.Wound vac in place: wound granulating and healing appropriately.¿ relevant medical information: (b)(6) 2016: ¿3 weeks status post mesh explantation and wound debridement and vac placement.Overall doing well without evidence of infection.¿ (b)(6) 2017: ct abdomen & pelvis ¿significant improvement with resolution of previous abscess collection associated with the mesh.There is mild supraumbilical and umbilical soft tissue density and stranding.¿ (b)(6) 2017: ¿3 week follow up of open abdominal wall wound, non healing but without evidence of infection.Not consistent with fistula but can¿t rule out undrained collection or communication with mesh.Referral to wound clinic.¿ (b)(6) 2017: ct abdomen/pelvis ¿evidence of soft-tissue inflammation/straining associated with inferior aspect of mesh shows interval improvement.¿ (b)(6) 2017: ¿has a massive belly.Wound above umbilicus.Sterile q-tip goes in gently up to about 0.7 cm.Some fibrous nonviable tissue that comes out of this wound.Culture of draining sinus tract grew out light growth of staphylococcus aureus sensitive to everything.May be related to contaminated mesh left behind in her abdomen.¿ (b)(6) 2017: ¿wound appears to track cephalad toward mesh.Doubt this will heal without mesh explantation.¿ (b)(6) 2017: ¿finished doxycycline about a week ago.Only change noticed was color of drainage changed from dark green to lighter green-yellow.Has wound that seems to be expanding slightly, length by width.She really did not respond to the antibiotics of 10 days of doxycycline for the mrsa.¿ (b)(6) 2017: ¿infected prosthetic mesh of abdominal wall.Open abdominal wall wound.Ct scan of the abdomen reveals fluid collection tracing from the wound to around the previous microporous mesh.¿ explant #3 [gore® dualmesh® biomaterial] preoperative complaints: (b)(6) 2017: ¿presents with a chronic abdominal wound.This is felt to likely be communicating with a previously placed mesh and this process would not resolve without removal of the foreign body.¿ explant #3 [gore® dualmesh® biomaterial] procedure: diagnostic laparoscopy.Extensive lysis of adhesions.Mesh explantation.Explant #3 [gore® dualmesh® biomaterial] date: (b)(6) 2017: procedure: ¿5 mm optical trocar was used to access the peritoneal cavity under direct visualization and co2 then insufflated creating pneumoperitoneum to 12 mmhg pressure.5 minute [sic] of 30° left scope was inserted confirming atraumatic intraperitoneal trocar placement.There were omental adhesions to the abdominal wall.Under direct visualization after local anesthesia and small skin incision, 2 more 5 mm trochars [sic] are placed.One in the midline infra umbilical region and another in the right upper quadrant.The original left upper quadrant trocar was later upsized to a 12 mm trocar to allow for extraction of the mesh.The scope was relocated to the infraumbilical trocar to facilitate regulation.Using combination of sharp and blunt dissection as well as electrocautery when needed, significant omental adhesions were taken down from the abdominal wall to facilitate exposure.This led to exposure of firm inflammatory capsule overlying the mesh.Using cautery, this was dissected off of the abdominal wall the previously placed mesh and removed from the patient.The mesh was then dissected away from the abdominal wall.There are multiple previously placed titanium hernia tacks that were kept with the mesh and removed.There are also multiple ethibond sutures which were divided and removed as well.Care was taken to avoid injury to the diaphragm.After takedown of the mesh, the abdominal wall and omentum were examined.There was some purulent and fibrinous material identified.This was suctioned.The area was irrigated copiously.A final survey was taken.There was no active issue.There was no bleeding.An endo pouch bag was inserted via the left upper quadrant trocar and the mesh was placed within the bag which was then closed and removed the fascial defect at this site was approximated with 0 vicryl figure of eight suture, placed with the gore suture passer using left scopic [sic] assistance.A culture was taken of the mesh which was then sent to pathology along with the inflammatory capsule.The remaining trochars [sic] removed as the pneumoperitoneum was evacuated.All sites were hemostatic.The trocar sites were approximated with 4-0 vicryl subcuticular and dermabond.¿ (b)(6) 2017: pathology and cytology: ¿specimen: a) explanted mesh.B) inflammatory rind.Final diagnosis: a) explanted mesh, removal: benign fibroconnective and adipose tissue with inflammation, reactive changes and foreign body giant cells surrounding foreign material.B) soft tissue, inflammatory rind, biopsy: fibroconnective and adipose tissue with inflammation, reactive changes and foreign-body giant cells.Gross description: a) explanted mesh consists of an approximate 9.0 x 7.0 x 0.1 cm synthetic mesh with a small amount of adherent soft tissue.Microbiology.Culture and aerobic + aerobic result: no growth at 48 hours.No anaerobes isolated.Gram reaction: 2+ pmn¿s, 2+ gram positive cocci in clusters.¿ relevant medical information: (b)(6) 2018: 4 weeks status post laparoscopic mesh explantation.Overall doing well without evidence of infection.Midline wound has healed.Notes scant drainage from one of the trocar sites that is improving.Left upper quadrant trocar site with 3 mm opening with scant serous drainage.Conclusion: gore® dualmesh® biomaterial (7225059/1dlmc03).It should be noted that the gore® dualmesh® 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.¿ the instructions for use further warn: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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.It was determined that the reported 1690: abscess was unrelated to this gore device.The reported 1695: adhesions were also unrelated to the gore device.The medical records state ¿there were multiple loops of bowel adherent to the anterior abdominal wall.¿ additionally, the alleged 1862: gastrointestinal fistula was not described in the medical records.It was also determined that the 2203: other used for ¿painful abdominal mass¿; ¿the mesh was noted to have "folded up and contracted and formed a 'meshoma'"; ¿fat necrosis and chronic granulation" were adequately captured with existing codes.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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