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

Model Number 1DLMCP07

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

Patient Problems Adhesion(s) (1695); Hernia (2240); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.

Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2002, whereby a gore dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2002, whereby a gore dualmesh® plus biomaterial was implanted.It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2004, whereby a gore dualmesh® plus biomaterial was implanted.It was reported the patient alleges the following injuries: recurrent hernia, additional surgery, extensive adhesions, mesh failure.Additional event specific information was not provided.

Manufacturer Narrative

Please note the initial medwatch indicates an incorrect date gore aware of (b)(6)2018.The date gore aware of information for the initial report is (b)(6)2018.B7: added medical history.H6: corrected results code.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6)1998, including records for the ¿hernial repair about ten or twelve years ago¿ noted in the (b)(6)1998 records and ¿big operation as a child¿ noted in the (b)(6)2001 records, were not provided.Operative records dated (b)(6)1998 indicate the patient underwent repair of a recurrent ventral hernia.¿he has had a hernial repair about ten or twelve years ago.This was done in california.Supposedly he had a significant component of the hernia above the umbilicus.Part of this was also diastasis according to the records from the previous surgeon.He also had an umbilical hernia repair, repaired with a few stitches of prolene.This has all recurred and he now has a 5-6 cm.Defect very clearly palpable below the umbilicus.Most of this seems to be to the right of midline.¿ the (b)(6)1998 operative report states: ¿an incision is begun to the right of the umbilicus and superiorly directed toward the upper midline incision but not including it initially.This is extended around the umbilicus and back down to the infra-umbilical midline.Dissection is carried down onto the hernia sac and it is quite extensive out in the subcu.The edges are dissected down to the fascial edges inferiorly first.That edge is fairly well-demarcated and without scar tissue from his previous repair.The area in the umbilical area is quite scarred in as expected.¿ the (b)(6)1998 operative records state: ¿there was recurrent hernia there with incarcerated omentum stuck up in it.This was all debrided and taken down.Because of the amount of tissue out in the hernia, it was more reasonable to amputate the hernia sac and the debridement than it was to try and place it all back into the abdomen.The peritoneum was wide open and a couple of small holes were just excised with the specimen.On palpation there was another defect up superiorly stemming from the old repair and this eased out to the right inside of the patient.This was opened to place it in continuity with the rest of this fascial repair that was needing to be done.Once i debrided all the sac and freshened all the fascial edges, hemostasis was obtained using electrocautery.Irrigation was accomplished.There was a little bloody fluid down in the abdomen and we washed this out.¿ the (b)(6)1998 records continue: ¿the omentum was placed over the small bowel.There was not any adhesions to the small bowel up to the hernia or the previous repair.With interrupted #1 vicryl sutures in smead-jones fashion were then placed in the fascia with good approximation without undue tension.Once this closure had been accomplished, the subcutaneous tissues were irrigated.There was a little laxity in the skin.The umbilicus was tacked down to the fascia with 3-0 vicryl interrupted suture.The subcutaneous tissues were irrigated with antibiotic saline solution.Additional local anesthetic was applied at the fascial level.Subcu closure was with deep dermal and inverted 3-0 vicryl sutures.Staples approximated the skin edges.Sterile dressing was applied.¿ a pathology report dated (b)(6)1998 regarding specimens collected (b)(6)1998 state: ¿gross description: received in fixative identified as ¿ventral hernia contents with debridement¿ are approximately 7 grams of pink yellow to whitish tan fibrofatty soft tissue measuring 8x8x2 cm.In aggregate.Some of the tissue portions exhibit incorporated suture material, consistent with the clinical history of recurrent ventral hernia.Sectioning reveals areas of increased fibrosis, but no other distinct mass lesions are identified.No foreign elements other than suture material are encountered.¿ ¿diagnosis: portions of variably sclerotic fibromembranous soft tissue with accompanying vascular and fibroadipose tissue elements, representing clinically described ventral hernia sac with contents, obtained during repair of recurrent ventral hernia.¿ records between 1998 and 2001 were not provided.Operative records dated (b)(6) 2001 states: ¿[the patient] is a 44 year old gentleman that had a big operation as a child.He has had hernias related to this.I repaired a hernia about four years ago in the lower abdomen.He now has a hernia in the right periumbilical area and also a small detect in the superior portion of the midline incision near the xiphoid.We plan repair.We will try and do primary repairs as indicated.Previous primary repair has held up nicely.¿ the (b)(6)2001 operative report states: ¿some of the distal old scar from the upper incision as well as some from the lower incision is excised as skin incision is made.Dissection is carried down to the right of the umbilicus to identify the hernia defect.There was some omentum protruding out through this and hernia sac dissected from the subcutaneous plane.The fascial edges are debrided.I felt superiorly and there is some diastasis.There is no hernia defect in the major portion of the upper midline incision, i could not reach the top part.There was one smaller defect to the inferior portion of our incision near the midline.This was incorporated into the repair.Hemostasis where adhesions were taken down was obtained using the electrocautery.The fascial edges were debrided using electrocautery instrument.Closure was within interrupted modified smead-jones type sutures of #1 maxon.This provided adequate fascial closure with good approximation of fascial surfaces without undue tension.¿ the (b)(6)2001 records continue: ¿subcutaneous closure after irrigation with interrupted 3-0 vicryl sutures.Skin staples were placed to approximate the skin edges.Additional local anesthetic was injected.A portion of the upper midline scar was removed and dissection carried down to the fascia.There was a fascial defect present.The edges of this were debrided.Basically the hernia was due to separation of running prolene suture.The fascial edges were debrided and the portion of the hernia pushed back down into the abdomen.Closure on top of this with interrupted #1 maxon sutures in modified smead-jones fashion.Subcutaneous sutures were placed after irrigation.Skin staples approximated the skin edges.Sterile dressing was applied to both incisions.¿ a pathology report dated (b)(6)2001 regarding specimens collected (b)(6)2001 state: ¿tissue is received in three separate containers of fixative.The first specimen, identified as "hernia contents,¿ is a rubbery, yellow-gray portion of fibrofatty soft tissue, which when laid out, measures 4,5x2x0.4 cm.Serial sectioning reveals lobulated fat with a supportive fibrous membrane.No foreign elements, ectopic tissue or distinct mass lesions are identified.¿ the (b)(6)2001 pathology report continues: ¿the second specimen, identified as ¿hernia sac,¿ consists of a saccular, purple-tan to white portion of fibrofatty soft tissue measuring 4x2x0.4 cm.The apparent inner surface is glistening and slightly trabeculated, while the outer surface is partially covered by fibrofatty tags.No foreign elements, ectopic tissue or distinct mass lesions are identified.¿ ¿the third specimen, identified as ¿scar tissue,¿ includes two elongated strips of whitish skin and subcutis.The longer skin strip measures 8x1.2x1 cm, while the shorter skin ellipse measures 6x0.8x0.6 cm.Both skin surfaces exhibit a well healed cicatrix, serial sectioning through both specimens suggests increased dermal fibrosis, consistent with scar formation.¿ the (b)(6)2001 pathology report states: ¿also received are three irregularly shaped, rubbery portions of fibrofatty soft tissue, one of which is elongated and fibrotic, with incorporated suture material.It measures 6xl.3x0.6 cm.Another portion is more saccular, measuring 5x3.5x0.5 cm.The third portion is of similar composition and measures 2x1.8x1.2 cm.Serial sectioning suggests increased fibrosis, consistent with scar formation.¿ the (b)(6) 2001 pathology report states: ¿diagnosis: portion of benign, congested fibroadipose tissue with patchy nonspecific chronic inflammation, consistent with clinically described hernia contents.Portion of benign hernia sac with dense fibrocollagenous tissue, obtained during incisional hernia repair.Portions (2) of benign skin with old scar (cicatrix) along with dense fibrocollagenous tissue with incorporated suture material consistent with soft tissue debridement associated with abdominal incisional hernia repair.¿ an intraoperative nursing record dated (b)(6)2002 states the patient underwent laparoscopic repair of a recurrent incisional hernia with mesh.The records confirm a gore dualmesh corduroy antimicrobial (1dlmcp04/01233368, 1dlmcp07/01310995) were implanted during the procedure.Site of implant for the meshes is noted as ¿ventral hernia [abdominal] wall.¿ an operative report for the procedure performed on (b)(6)2002 was not provided.Records between (b)(6)2002 and(b)(6)2004 were not provided.History and physical notes dated (b)(6) 2004 state: ¿the patient is a 47-year-old man with a history of multiple previous ventral hernia repairs.He is unclear about the origin operation that resulted in the hernia; dr.(b)(6) felt that it was most likely an attempted repair of diastasis recti.The most recent hernia repair was a laparoscopic herniorrhaphy by dr.(b)(6) two years ago.Dr.(b)(6) described a long, extensive procedure, with a lot of omenta and bowel adherent to the abdominal wall.Multiple defects were repaired with a large intraperitoneal sheet of dualmesh.In recent weeks, the patient has noticed a recurrence of the incarcerated hernia to the left of the midline.This is apparently just below the edge of the old mesh.Computerized tomography (ct) scan on june 29 showed a loop of small bowel protruding out of this hernia.¿ an operative report describing the procedure and aforementioned findings performed two years prior was not provided.Additionally, a ct scan report from (b)(6)2004 was not provided.The (b)(6) 2004 history and physical notes state: ¿the patient presented to the emergency room on august 8, which is the date he was admitted with complaints of pain and nausea.A several-centimeter mass was present at the level of the umbilicus to the left of the midline.I was successful in reducing at least most of this mass, and he had resolution of his symptoms.His white blood cell count in the emergency room on august 8 was 16,000; it had dropped to normal by the following morning.¿ ¿past surgical history: by history it appears that all of his abdominal surgeries have related to the diastasis recti repair and multiple subsequent hernias.He has had no other abdominal surgery.¿ abdominal exam states: ¿the abdomen is soft and nontender.This morning the hernia is protruding once again, but is still soft.There are no other masses or hernias noted.¿ ¿impression: current ventral incisional hernia.Plan: ventral herniorrhaphy with mesh.¿ records dated (b)(6) 2004 indicate an abdominal x-ray was performed.¿findings: there is no free subdiaphragmatic air.There are small air-fluid levels in the mid abdomen and there are fluid-filled loops of bowel in the abdomen.Changes consistent with previous hernia surgery are noted.There is air and stool to the region of the rectum.¿ impression: ¿changes that may represent a gastroenteritis although early small bowel obstruction could also give this appearance.¿ operative records dated (b)(6)2004 state the patient underwent ¿1.Prosthetic mesh repair, recurrent ventral hernia.2.Lysis of adhesions¿ for a diagnosis of ¿incarcerated recurrent ventral hernia.¿ ¿a transverse incision was made just to the left of midline and just below the umbilicus.Adequate skin bridges were left between the medial end of the incision and the old midline scar.This was centered directly over the location of the protruding hernia.Sharp dissection was carried down a thin layer of grossly-normal fat.The partially-empty hernia sac was identified and, with sharp and cautery dissection, was freed from the subcutaneous fat.Virgin fascia on the inferolateral edge of the hernia defect was identified and i dissected medially, clearing fascia up to the edges of the defect.¿ the (b)(6)2004 operative report states: ¿the apex of the sac was opened and a loop of small bowel was adherent into it.I think that, when he first presented to the emergency room, there had been a loop incarcerated which i had been able to reduce.The excess sac was debrided.Adherent small bowel into the sac was freed with sharp dissection.I found loops of small bowel adherent (nearly circumferentially) around the defect.In a couple of places, it was adherent to the spiral tacks that had been used on a previous laparoscopic repair.With some very tedious dissection, the bowel was freed from these tacks without causing any perforation.There was also adherent bowel around the inferior edge of the defect which did not appear to have been involved with any mesh previously.The hernia defect had protruded through along the inferolateral corner of the old piece of mesh.¿ the (b)(6)2004 operative report continues: ¿an 8x10 cm oval patch of dual mesh was trimmed, after the defect was measured.With cautery dissection, the scarred subcutaneous fat medially was freed from the fascia.The mesh was sutured in place in the peritoneal cavity, taking full-thickness mattress sutures of 0 prolene through either the native fascia below or the mesh above.I overlapped the edges of the defect 4-5 cm in each direction.The actual size of the defect was only about 20x25 mm.The field was irrigated; no bleeding was seen.The fascia on the lower edge of the defect was sutured to the edge of the old mesh along the upper edge using interrupted prolene; this closed without tension and buckling the new mesh beneath.A jackson-pratt drain was placed in the subcutaneous space.The subcutaneous fat was closed with running vicryl and the skin was closed with staples.¿ the records indicate a gore dualmesh® plus biomaterial (1dlmcp04/02731421) was implanted during the procedure.There was no mention of infection and no mention of removal involving the previously implanted gore dualmesh® biomaterial devices.Records from 2010 to 2012 will be provided in a separate report.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

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) 2010: office visit.Hpi: recurrent ventraql [sic] hernias repaired as open procedures with mesh now with new herniation superior to the previous repairs no sx¿s of bowel incarceration or sx¿s.Physical exam: abdomen: no mass, no tenderness, normal bowel sounds (visible and palpable ventral hernia a epigastrum superior [sic] to the umbilicus defect 6 x 4 cm reducible and nttp inferior abd without evidence of herniation no inguinal masses skin ok).Dx: ventral hernia uspec.Plan: discussed aspects of laparoscopic ventral hernia repair risks and expectations.Schedule for laparoscopic ventral hernia repair possible open procedure.(b)(6) 2011: office visit.Hpi: post-op wound.Pe: inspection of skin, incision: no redness or drainage (clips repair intact some fluid in hernia site).(b)(6) 2011: office visit.Hpi: pre-op visit.Presented with post-op wound.Jp with nil serous drainage finishes antibiotic tomorrow.Pe: wound clean no drainage clips out sp out repair intact.Dx: ventral hernia uspec; unsp cellulitis/abscess.(b)(6) 2011: office visit.Hpi: presented with hernia repair.Noticed a mass left of midline in epigastrum nttp.Pe: bulge in epigastrum w/ valsalva c/w with recurrent hernia defect 3 by 4 cm nttp reducible no other hernias or masses felt.Dx/plan: ventral hernia unspec.Will eventually need to consider repair if this changes or enlarges.(b)(6) 2012: office visit.Hpi: presented with hernia.Hx of complex ventral hernia with multiple operations for repair infected mesh repair with biological mesh now with expected progressively enlarging hernia superior aspect.Pe: abdomen: normal bowel sounds (visible bulge right of midline superior aspect defect 6 by 6 cm inferior abd to skin ok).Dx: recurrent ventral hernia.Plan: need ct scan to egval [sic] abd wall as he has a complex problem and is ttp inferior abd not sure why then will have o [sic] consider the best approach for him probably some variant of component separation.(b)(6) 2012: office visit.Hpi: presented with post-op wound.Pe: no redness or drainage.(1/2 clips removed slight show of old blood seroma drainage superior wound no purulence [sic].) (b)(6) 2012: office visit.Hpi: post-op wound.Pe: inspection of skin, incision: no redness or drainage (clips out to ss).(b)(6) 2012: office visit.Hpi: post-op wound.Pe: inspection of skin, incision: no redness or drainage (repair intact abd strong).11/10/14: office visit.Hpi: recurrence of large complex abdominal wall hernia no pian [sic] no ttp.Assessment/plan: had multiple hernia surgeries infected wounds etc now with recurrence of mid to low abd wall hernias will need a ct scan of the abd wall to assess what we are dealing with.(b)(6) 2014: missing records: ct scan records not provided.(b)(6) 2014: office visit.Hpi: large recurrent incisional hernia mild ttp no obstruction reducible ct reviewed.Assessment/plan: incisional hernia.Discussed large procedure to repair hernia.Schedule open incisional hernia repair.(b)(6) 2015: missing records: operative report for open incisional hernia repair not provided.(b)(6) 2015: office visit.Hpi: here to discuss options of inciososnal [sic] hernia.Abdomen: complex central abd inc hernia partially reducible with at least three palpable fascial defect partial loss of domain.Assessment/plan: is interested in particularly [sic] mesh application of reapri [sic] of hernia will eval with the hospital.(b)(6) 2015: office visit.Hpi: here to discuss further options regarding repair.Assessment/plan: ventral hernia unspec.May consider referral to tertiary center.(b)(6) 2015: missing records: medical records between 08/07/15 and 11/06/17 were not provided.(b)(6) 2017: office visit.Hpi: has a giant ventral hernia with partial loss of domain.Is here to talk about trying to referred to medical center in dallas.Physical exam: abdomen: giant ventral hernia with multiple lobulations tenderness is elicited.Assessment/plan: incisional hernia.Is interested and [sic] some form of developmental research on reconstructive prosthetics for hernias wants me derive a cover letter to her [sic] research director at methodist hospital in dallas regarding this subject told him that the research interested is fine.Does not address the problem of giant ventral hernia which she [sic] will have to go to a hernia center to have this addressed.(b)(6) 2018: progress notes.Evaluation of a giant ventral hernia.Has had 10 abdominal surgeries- all by dr.(b)(6) in nwa- for various hernia repairs/revisions/mesh infection.Last operation was about 3 years ago.Supraumbilical hernia repair remains intact, however, has 3 large hernias in lower abdomen.Is asymptomatic from these hernias, however, states he has a long life to live and that they need to be taken care of.Understands that he¿s 25 pounds overweight and believes he will be able to lose the excess weight when hernia is repaired.Last ct was about 3 years ago.Has been told about dr.(b)(6) reputation and would like him to perform the repair.Has been told that plastic surgery will need to be involved in repair for cosmetic reasons.Of note, would like to discuss an idea he has for a new type of hernia repair with the uams research and development department.Would not say what it entails but states knows many meshes are made overseas in korea and president trump stated he would expedite studies through the fda that would save a life.Assessment/plan: has 3 large hernias that are soft and reducible.Not tender to palpation.Will need more recent imaging before we can begin to evaluate for a hernia repair in the future.Will have ct done in harrison.(b)(6) 2018: missing records: ct imaging records not provided.(b)(6) 2018: progress notes.Recurrent ventral hernia.Many recurrences and mesh infections in the past.Has an idea for an experimental hernia repair system which is what he wishes to discuss in clinic today.Hernia defect is very large and am afraid he would possibly have a long time on the vent or even be dependant [sic] on the vent.Tried to discuss vent dependence, need for a colonoscopy, and needing to get op reports before planning surgery.The only context in which he wishes to discusses his hernia repair is with his system, which he wouldn¿t discuss with me and that he would need to set up a non-clinical meeting with a willing surgeon (¿in the research depertment [sic], please¿).Asked for our nurse to discuss with him.Told him i don¿t do experimental hernia surgery.May follow up in clinic after he¿s decided on a traditional mesh repair or has gotten fda approval for his mesh.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

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) 2012: (b)(6) medical center.(b)(6) md.Office visit.Wt 218.6, bmi 30.49.Hpi: recurrent abd pain and swelling.Pmh: hyperlipidemia.Social hx: former smoker.Impression: abd pa abdominal pain.Abdominal or pelvic swelling, mass or lump, unspecified site.Incisional hernia without mention of obstruction or gangrene.Plan: abdomen and pelvic ct appt made at narmc for (b)(6) 2012.F/u 2-3 days.(b)(6) 2012: (b)(6) medical clinic.(b)(6) md.Office visit.Wt 213, bmi 29.70.Diabetes type ii.(b)(6) 2016: (b)(6) medical clinic.Phone call.Patient has positive c diff and campylobacter.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: on (b)(6) 2010: (b)(6) center.Surgical documentation.Wound class: ii clean contaminated.On (b)(6) 2011: (b)(6) center.Surgical documentation.Entry 1: incision and drainage.Wound class: iv dirty/infected.Entry 2: exploratory laparotomy.Wound class: iv dirty/infected.On (b)(6) 2011: (b)(6) center.Cultures and stains.Procedure: culture anaerobic.Source: swab.Body site: other.Free text source: removed abd mesh.Accession: 11-018-2127.Final report: heavy growth bacteroides fragilis group.Procedure: gram stain.Source: swab.Body site: other.Free text source: removed abd mesh.Accession: 11-018-2126.Final report: no pmn¿s.Many gram positive cocci pairs chains clusters.Moderate gram positive rods.Few gram negative rods.Procedure: culture aerobic.Source: swab.Body site: other.Free text source: removed abd mesh.Accession: 11-018-2125.Final report: sparse methicillin resistant staphylococcus aureus; contact isolation required.Moderate growth klebsiella pneumoniae.Moderate growth streptococcus milleir, viridans group.On (b)(6) 2011: (b)(6) center.Surgical documentation.Entry 1: wound exploration.Wound class: ii clean contaminated.Entry 2: wound closure.Sound class: i clean.On (b)(6) 2011: (b)(6) center.Surgical documentation.Entry 1: exploratory laparotomy.Wound class: ii clean contaminated.Entry 2: wound closure.Wound class: i clean.On (b)(6) 2012: (b)(6) center.Surgical documentation.Entry 1: wound class: ii clean contaminated.On (b)(6) 2012: (b)(6), md.Discharge summary.Discharge diagnosis: recurrent ventral hernia.Procedure: mesh underlay repair of recurrent ventral hernia.History and hospital course: this is a 55-year old patient who i had operated previously for complex ventral hernia repair.He underwent a laparoscopic repair at that time, but then developed a mesh infection.This required return to the operating room and removal of the mesh.His persistent ventral hernia now has become more apparent and he is brought back to the operating room, and underwent a mesh underlay repair of his ventral hernia.Postoperatively, he progressed satisfactorily.At time of discharge, he was given instruction as to diet, followup, and activity.His pathology report demonstrated hernia sac with giant cell reaction.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6) 2010 state: ¿[the patient] is now 54.He is a remote patient.He had a big huge incisional hernia or diastasis operation or something many years ago.He advised me and i don't have the records from this so it has been at least seven years and we have thinned our charts, that i repaired a recurrent incisional hernia in the lower abdomen.He now has diastasis recti and probably hernia in the epigastric area of a long midline incision.¿ ¿social history: ¿no alcohol, no tobacco use but he use to smoke a lot and i suspect that he was smoking during that period of time when he was having these operations done.¿ abdominal exam notes state: ¿protuberant body habitus.Long midline incision.Obvious diastasis recti from the umbilicus to the xiphoid and then on the left side feels like there is a hernia defect there.He says this is enlarging over the last six months.Lower abdomen seems ok.¿ impression and plan notes from the (b)(6) 2010 visit state: ¿recurrent incisional hernia.¿ ¿we need to see the op notes from his last operations which were done at cox in springfield.We will get the narmc records of the operations that i preformed and then try to decide what is the best course to take.I have advised him that just going in and adding another piece of mesh to the mixture is sometimes very suboptimal.I have advised him also that the potential for incarceration with an epigastric hernia much less than a lower abdomen and that has to do with pressure and gravity and how they affect hernias in general.I don't wish to make any prediction and offer him an operation at this time or even begin to image how we would approach this.We will need to review the records with him.¿ records dated (b)(6) 2010 state: ¿has recurrent [ventral] hernias repaired as open procedures with mesh now with new herniation superior to the previous repairs no [surgeries] of bowel incarceration or [surgeries] [sic].¿ operative records dated (b)(6) 2010 state the patient underwent ¿1.Laparoscopic lysis of adhesions, taking 45 minutes.2.Laparoscopic incisional hernia repair utilizing 15 x 20-cm atrium dual-layer mesh.¿ post operative diagnosis states: ¿recurrent incisional hernia.¿ findings from the (b)(6) 2010 procedure state: ¿findings are that of an incisional hernia involving the mid epigastrium just to the left of the midline.There were three adjacent defects of the fascia, which were somewhat fenestrated in orientation.The defects each were approximately 2-3 cm in diameter.There was incarcerated omentum within the defects and incarcerated loop of bowel within the defect.There was an extensive amount of adhesions from previously placed mesh from previous incisional hernia repairs.There was no evidence of bowel compromise.¿ the (b)(6) 2010 operative report states: ¿with careful blunt and sharp dissection, 45 minutes almost to an hour were spent taking down anterior abdominal wall adhesions and small bowel adhesions.This sequentially was performed until the defects were able to be visualized and the incarcerated contents carefully reduced.After reducing the incarcerated defects, the falciform ligament was freed superiorly, and the membranes of the hernia defects as a hernia sac were sharply resected.Then transabdominal passage of a 22-gauge spinal needle was utilized to orient the defects for measurement of their size.After this was accomplished, a 15 x 20-cm dual-layer atrium mesh was selected, and the mesh was appropriately marked and then furled.An o vicryl suture was placed on the anterior portion of the mesh at the site for the transabdominal fixation.¿ the (b)(6) 2010 operative report continues: ¿then the mesh was placed in the abdomen and appropriately oriented with the transabdominal suture passer utilizing to retrieve the vicryl suture and orienting the mesh up against the abdominal wall adjacent to the defects.Utilizing the autosuture titanium spiral tacker, the mesh was secured superiorly and inferiorly.After this was accomplished, the mesh was then unfurled, and the lateral margins of the mesh were sequentially secured with placement of the titanium tackers.The orientation of the mesh appeared to be appropriate and flat, and no pleating was seen.The bowel was noted to be without evidence of compromise.Therefore, the pneumoperitoneum was evacuated, and the ports were removed.¿ the records indicate an atrium mesh (non-gore device) was used during the procedure.There was no mention of infection and no mention of device removal involving the gore devices.A pathology report dated (b)(6) 2010 regarding a specimen collected (b)(6) 2010 states: ¿specimen submitted: ventral hernia sac.Gross description: specimen received in formalin in a single container labeled with¿"hernia sac" is a pink fragment of membranous tissue measuring 3 x 1 x 0.2 cm.The membranous tissue is smooth-lined without any papillations nor trabeculations.¿ ¿final diagnosis: ventral hernia sac: hernia sac with mild fibrosis.No granuloma nor malignancy identified.¿ discharge summary records dated (b)(6) 2010 state: ¿this is a 54-year-old patient who has had previous midline abdominal wall hernia repairs attempted in the past and now has a recurrent symptomatic epigastric ventral hernia.He underwent laparoscopic approach and was noted to have three adjacent fascial defects.This was repaired with a dual-layer atrium mesh underlay technique.Postoperatively, he was progressing and at time of discharge was accepting a diet, was ambulating, and wounds were healing in adequately.¿ history and physical notes dated (b)(6) 2011 state: ¿this is a 54-year-old patient who almost three weeks ago i operated on for an incarcerated epigastric ventral hernia.This was repaired laparoscopically with an underlay repair of dual-layer atrium mesh 15 x 20 cm.He had been seen in the office postoperatively and was recovering satisfactorily.The patient then presented to the emergency room in harrison, arkansas when he noted that he had an acute episode of swelling and erythema and some discharge from his suture wound.He was transferred over here and was found to have evidence of a draining abdominal wall abscess.He denies any changes in his bowel habits and no generalized abdominal pain otherwise.¿ operative records dated (b)(6) 2011 state the patient underwent ¿exploratory laparotomy with drainage of abdominal abscess with explantation of previously placed ventral hernia repair mesh¿ for a diagnosis of ¿postoperative abdominal wound infection.¿ ¿findings were that of [an] abscess involving drainage through a small suture placement wound of the midline overlying the hernia repair.Opening this revealed a foul smelling abscess with golden colored drainage emanating from this.Multiple cultures were taken.This involved the space between the mesh and the fascia.The fascia was totally disrupted away from the parietal fascial margin.Explantation of the mesh did not reveal any evidence of enteric fistula or bowel compromise.No other extension of abscesses were seen, other than a localized area in front of the mesh.¿ the (b)(6) 2011 operative report states: ¿midline incision directly over the previous incision line was taken down and the abscess cavity was entered readily.A transversely oriented incision was extended to the right of the midline and 1 to the left of the midline overlying the 2 subcutaneous hernia site pockets to afford exposure and drainage of these areas.The underlying mesh was carefully evaluated and was noted to be almost completely disrupted and free floating within the abdomen.It was removed intact without difficulty.The wound was copiously irrigated with normal saline and evaluated and specifically there was enteric source searched for and none was found.The bowel was noted to be intact.Therefore, the wound was left open with white sponges and black overlying sponges for the vac dressing were put in place.¿ it is unclear from the records which meshes were explanted during the procedure.A pathology report dated (b)(6) 2011 regarding specimens collected (b)(6) 2011 state: ¿specimens submitted: removed mesh from abdomen.Gross description: a.The specimen is received in formalin labeled with the patient's name and ¿removed abdominal mesh¿.The specimen consists of three portions of synthetic mesh material and portions of suture material also present.The fragments of mesh measure 29 x 15.2 x 0.4 cm in aggregate.Metallic springs are also present throughout the specimen.No tissue is present and no sections are submitted for histologic examination.¿ ¿final diagnosis: a.Clinically removed abdominal mesh: portions of mesh material grossly consistent with stated origin; gross examination only.¿ operative records dated (b)(6) 2011 state an ¿operative wound exploration and washout procedure¿ was performed for a ¿postoperative abdominal wall abscess.¿ ¿the patient two days previously had had abdominal wall abscess drained with explantation of ventral hernia repair mesh.He was growing multiple species noted on the gram stain, and klebsiella was beginning to be identified as well.No enteric source had been identified.He had been managed with a vac dressing, and after institution of adequate anesthesia, the vac dressing was removed.The wound was prepared with betadine and draped with sterile drapes.Exploration of the wound did not reveal any evidence of an enteric source or fistulization.No extension of abscess cavities were seen.The wound was recultured, and with the pulsavac lavage apparatus, the wound was copiously irrigated and cleaned.The initial intent was to evaluate to see if the fascia could be dealt with, and it was felt that it would not be approximated at this time in that he needed another period of further wound management before primary definitive closure of his fascial defect.Thus, a new vac dressing was applied, and he was taken to the recovery room in good condition.¿ a microbiology report dated (b)(6) 2011 regarding specimens collected (b)(6) 2011 state: ¿organism 1: klebsiella pneumoniae light growth.Organism 2: group f strep (beta hemolytic) light growth.Organism 3: coag negative staphylococcus rare growth.¿ ¿anaerobically: moderate mixed growth, including presumptive bacteroides species x2 and peptostreptococcus sp.¿ operative records dated (b)(6) 2011 state the patient underwent ¿abdominal wound exploration with closure of abdominal wound with technique of underlay of 16 x 6-cm biologic allomax mesh technique¿ for a ¿postoperative abdominal wound infection with disruption of previous ventral hernia repair.¿ the (b)(6) 2011 operative report states: ¿the wound was carefully evaluated and the previous drainage and lavage procedures and placement of the wound vac had resulted in healthy-appearing granulation tissue and no evidence of residual infection or purulence.Again, a source for enteric communication was searched for and none was identified.The patient had been previously tolerating oral diet intake.The fascial margins had lost some of their stiffness and were noted to be able to be approximated in the midline and thus allomax mesh 16 x 6-cm was selected and as an underlay technique, was secured transfascial with prolene suture out beyond the margin of the fascial wound.After this was accomplished, the fascia itself was closed overlying the mesh with interrupted 0-prolene suture.Then, a 19-french blake drain was brought from its base between the mesh and the fascia and placed to close suction drainage.The skin was closed loosely with skin clips.¿ the records confirm an allomax surgical graft (non-gore device) was used during the procedure.Discharge summary records dated (b)(6) 2011 state: ¿the patient is a 54 year old male.Three weeks prior to this presentation, he had what was thought to be an uncomplicated laparoscopic ventral hernia repair for an incarcerated epigastric ventral hernia.He had been seen postoperatively in the office and then the day of admission, he presented to the emergency department with increased abdominal pain, swelling, and drainage from a small midline wound where the transfascial stitch had been placed.He was transferred over here from harrison, arkansas.Upon evaluation, he was taken to the operating room and underwent drainage of the large abdominal wall abscess.The abscess was noted to lie between the mesh and the fascia.There was no evidence of an enteric source for this; specifically, no enteric fistula or bowel compromise was seen.¿ the (b)(6) 2011 discharge summary records continue: ¿the mesh was explanted and he underwent two procedures to continue cleaning the wound up and allowing the stiffness of the fascia to resolve before primary closure.Then, he was brought back to the operating room and underwent a primary closure of this wound with the assistance of an underlay biologic mesh placement.Several species were noted on gram stain and klebsiella was the predominant organism which had been cultured.¿ ¿discharge diagnosis(es): postoperative abdominal wound infection after laparoscopic ventral hernia repair, resulting in abdominal wall abscess.Multiple abdominal surgeries for previous ventral hernia repairs.¿ records dated (b)(6) 2012 state: ¿[history] of recurrent ventral hernia repairs with mesh [infection] etc now with recurrent [ventral] hernia with incarceration of colon and small bowel no obstruction.¿ abdominal exam notes state: ¿no tenderness (visible and palpable ventral hernia supraumbilical 2-3 defects) and normal bowel sounds.¿ operative records dated (b)(6) 2012 state the patient underwent ¿mesh underlay repair of recurrent incarcerated incisional hernia.¿ findings state: ¿the patient had multiple previous midline ventral incisional hernias that were repaired and had a history of a complicated laparoscopic repair and then the mesh became infected and had to be removed.He now presents with multiple fenestrated defects along the medial rectus sheath at and superior to the umbilicus with incarcerated loops of small-bowel within the hernia defects.There is no evidence of bowel compromise.The defects were mainly involved superior to the umbilicus.No other hernia defects were noted after reduction of incarcerated bowel loops.No evidence of bowel compromise was noted.The liver appeared to be normal.The gallbladder was specifically evaluated and noted to be normal in appearance and consistency and no cholelithiasis was palpated.¿ the (b)(6) 2012 operative report states: ¿ the previous upper midline scar was removed and the incision was carried down to the level of the fascial defects, which were sequentially opened.With careful sharp and blunt dissection, the adhesed small-bowel and colon loops and omental loops were lysed from the anterior abdominal wall.This allowed visualization of the incarcerated bowel contents and these were carefully reduced from the hernia defects.Each defect was estimated to be approximately 2 to 3.5 cm in diameter.Two were on the right side along the medial aspect of the rectus sheath and 2 were on the left side at the medial aspect of the rectus sheath.After lysis of adhesions was accomplished, the bowel loops were carefully evaluated.No evidence of bowel compromise was seen.The bowel was allowed to lie in its normal anatomic orientation.Then the estimated overall extent of the defect of the anterior abdominal wall was measured.With the multiple fenestrated defects, it was found ethicon proceed dual-layer mesh 15 x 20-cm diameter was selected.This would be placed as an underlay technique.¿ the (b)(6) 2012 operative report continues: ¿the mesh was secured circumferentially with transfascial sutures of o prolene, securing the mesh at a distance of 3 to 4 cm lateral to the hernia defect circumferentially.At least 7 of these transfascial sutures were placed.This was done with the suture passer.Next, the peritoneal reflection within the hernia defects were removed and the fascia over the midline was then closed with application of interrupted o prolene sutures with every 3rd to 4th bite grasping and incorporating the anterior margin of the mesh, pulling it up against the abdominal wall.Prior to closure of the fascia, interrupted 3-0 vicryl sutures were sequentially placed to help close any potential windows for migration of bowel up anterior to the mesh.After the fascial closure was accomplished, the subcutaneous space was irrigated and then the skin closed with skin clips.¿ there was no mention of previously implanted meshes in the records.A pathology report dated (b)(6) 2012 regarding specimens collected (b)(6) 2012 states: ¿specimens submitted: ventral hernia sac.Gross description: a.Received in formalin in a single container labeled ¿"hernia sac" are multiple segments of tan-purple membranous tissue and adipose tissue admixed with probable mesh which measure 3.5 x 3 x 1.5 cm in aggregate.The specimen is serially sectioned and no obvious abnormalities are identified.¿ ¿final diagnosis: ventral hernia sac: hernia sac with mild fibrosis and foreign body giant cell formation.No malignancy identified.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

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) 2002: (b)(6) clinic.(b)(6) md.Office visit.Hpi: had a ventral hernia repair in 1992, subsequent recurred.Was re-repaired in 1999, recurred again, fixed a third time in 2001.As far as we know, mesh has never been used.Having painful symptoms around rim of major part of the hernia and desires repair.Abdomen: lengthy midline scar.Mid part of scar has undergone a fascial dehiscence revealing a 5-6 cm fascial defect.Large sac is present, reducible.Thickening superiorly which may harbor more incisional hernias, but difficult to feel.Impression: recurrent incisional hernia.Plan: laparoscopic repair, recurrent incisional hernia.Discussed potential complications with regards to recurrence and infection.I indicated that with port placement should there be a visceral injury or hemorrhage present we may need to convert to open procedure or should there be severe adhesions present it may need to be open.This may limit use of mesh.He understands and wishes to proceed.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Phone note.¿mr.(b)(6) underwent laparoscopic repair of multiple incisional hernias today.Adhesions were extensive and required some time for lysis.The total area involved was 15 x 7 cm and a large patch was placed over this without difficulty.¿.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.Wounds healing well.If there is a seroma, it is not very palpable, we have elected not to try and reaspirate.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.Last week noticed painful symptom inferiorly.Area where most inferior anchoring stitch should be.States it is tugging, pulling, causing sharp pains.Pain is not always in this location and is sometimes around the patch itself.Rx.(b)(6) 2002-(b)(6) 2002: [missing records: hospital records for ¿couple days in hospital with some fever¿ were not provided.].(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.10 days postop.Spent couple days in hospital with some fever.Wounds healing well, removed staples.Aspirated a 35 ml seroma from the larger of the hernia sacs.Plans to return to work in a week or 2.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.Continues to have pain at lower aspect of site.Primarily over the most inferior anchoring stitch.Discussed options of observation, injections and removing stitch (the last may predispose this patch to migrate out through the defect).He agreed to injection today.I injected this area with 5 mm [sic] 1% xylocaine with epinephrine.Seemed to have relief.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.Repair continues to be intact.Painful systems 80% improved with injection.I have re-injected this area, at his request with 5 ml 1% xylocaine.(b)(6) 2002: (b)(6) clinic.(b)(6) md.Office visit.Wounds continue to be well healed, repair is intact.States as long as he takes vioxx [nsaid, treats pain], he can work and do whatever he wants without problems.(b)(6) 2003: (b)(6) clinic.(b)(6) md.Office visit.He just got through putting out 3 sacks of feed for the deer.Repair is intact.(b)(6) 2004: (b)(6) clinic.(b)(6) md.Office visit.Has noticed a bulge to l and lower of his repair.Appears to be recurrence here.(b)(6) 2004: (b)(6) clinic.(b)(6) md.Radiology ¿ ct abdomen.Indication: abdominal hernia.Findings: hernia repair sheet/mesh is noted in supra-umbilical region.Evidence of a l infraumbilical hernia with an opening in the abdominal wall measuring 2.9 cm in diameter and the hernia situated between radiopaque coil like fasteners from the hernia repair.Hernia sac measures up to 8.2 cm in diameter and contains a small bowel loop.Impression: l infraumbilical hernia sac.The hernia occurs along the inferior margin of the coil-like structures of the mesh-like substance from previous hernia repair.Majority of mesh is in the supra-umbilical region and this area appears to be intact.Hernia sac contains a small bowel loop which has a relatively unremarkable appearance.There appears to be mild fatty infiltration of liver.(b)(6) 2004: (b)(6) clinic.(b)(6) md.Office visit.Cc: hematochezia.Hpi: gastroenteritis with vomiting, diarrhea.Then constipation, eventually passed hard stools with some blood on tissue.Pmh: has had 5 recurrent hernias, 5th surgery pending (b)(6) 2004.All abdominal wall hernias, apparently started with umbilical hernia as child.Abdomen: full, distended, long dramatic scar down midline.Plan: colonoscopy prior to hernia repair.(b)(6) 2004: (b)(6) clinic.(b)(6) md.History and physical.Dx: incarcerated recurrent ventral hernia.Multiple previous ventral hernia repairs.He is unclear about origin operation that resulted in hernia.Dr.(b)(6) felt it was most likely an attempted repair of diastasis recti.Most recent was 2 years ago.Multiple defects repaired with a large intraperitoneal sheet of dualmesh.Has noticed recurrence of incarcerated hernia to l of midline.Apparently just below the edge of old mesh.Ct (b)(6) 2004 showed loop of small bowel protruding out of hernia.Presented to emergency room (b)(6) 2004, date admitted, c/o pain and nausea.A several cm mass was present at level of umbilicus to l of midline.Successful in reducing at least most of this mass, he had resolution of symptoms.Abdomen: hernia is protruding once again, still soft.Impression: current ventral incisional hernia.Plan: ventral herniorrhaphy with mesh.(b)(6) 2004: (b)(6) clinic.(b)(6) md.Office visit.2 ½ weeks post repair of focal recurrence of previously repaired ventral hernia.Incision clean, healing well.Wants to know when he can return to work.Managerial position at wal-mart, he can go back at any time.Will remove staples, to return prn only.Cautioned him to avoid heavy lifting for another month.(b)(6) 2004: [missing records: colonoscopy report was not provided.].A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 1995: [missing records: an operative report detailing ¿repair ventral/umbilical hernia¿ was not provided.] (b)(6) 1998: (b)(6).Outpatient procedures/short stays.Ventral hernia 12/95 repair ventral/umbilical hernia.(b)(6) 1998: (b)(6).Consultation.Recurrent ventral hernia.Had repair about six months ago but the lesion has broken open again.Records between 10/30/98 and 07/12/01 were not provided.(b)(6) 2001: (b)(6).History and physical.Abdomen: small hernia defect at top of midline incision just below the xiphoid area.Just to right of umbilicus, another defect.(b)(6) 2012: (b)(6).Radiology ¿ ct abdomen/pelvis.Indication: abdominal pain.Impression: two anterior abdominal wall hernias containing loops of bowel.Small fat containing left inguinal hernia.Diverticulosis.(b)(6) 2014: (b)(6).Radiology ¿ ct abdomen/pelvis.Indication: abdominal wall hernia.Findings: fat containing left inguinal hernia.Impression: interval enlargement of ventral abdominal wall hernia with neck of hernia measuring 7.4 x 10.2 cm in transverse and cephalocaudal dimension.Multiple compartments within hernia sac in anterior abdominal soft tissues.Hernia contains small bowel loops, non-obstructed.(b)(6) 2018: (b)(6).Radiology ¿ ct abdomen/pelvis.Indication: large ventral hernia.Impression: large ventral hernia with one common neck with hernia sac separated into at least two, possibly three sacs with largest sac on right.Inferior to umbilicus.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® plus 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.¿ 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.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2002: (b)(6) medical centers.Implant sticker.Site: ventral hernia abd wall.Dualmesh corduroy antimicrobial.Item #: 1dlmcp04.Lot #: 01233368.Dualmesh corduroy antimicrobial.Item #: 1dlmcp07.Lot #: 01310995.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/01233368, 1dlmcp07/01310995) was implanted during the procedure.(b)(6) 2002: (b)(6) medical centers.(b)(6).Progress notes.Pod #1.Temp 100.8.Abd distended, tender only over wounds and patch.Wound sites all look fine.(b)(6) 2002: (b)(6) medical centers.(b)(6).Progress notes.Pod #2.Temp generally [down], 100.Tenderness [decreased], port sites ok; hernia sac full of fluid.(b)(6) 2002: (b)(6) medical centers.(b)(6).Progress notes.Pod #3.Temp to 101.Tenderness over edges of patch; a little erythema over hernia sac.Ab¿s [antibiotics] started last night.(b)(6) 2002: (b)(6) health systems.Discharge instructions.Bathing: shower.Lifting: limit to 10 pounds.Driving: may resume when dr.Releases.(b)(6) 2004: (b)(6).(b)(6).Radiology ¿ xr abd ap.Indication: abdominal pain, multiple hernia surgeries.Findings: there is no free subdiaphragmatic air.There are small air-fluid levels in mid abdomen, there are fluid-filled loops of bowel in abdomen.Changes consistent with previous hernia surgery noted.There is air and stool to region of rectum.Impression: changes may represent a gastroenteritis although early small bowel obstruction could also give this appearance.(b)(6) 2004: (b)(6).(b)(6), md.History and physical.Dx: incarcerated recurrent ventral hernia.Multiple previous ventral hernia repairs.He is unclear about origin operation that resulted in hernia.Dr.(b)(6) felt it was most likely an attempted repair of diastasis recti.Most recent was 2 years ago.Multiple defects repaired with a large intraperitoneal sheet of dualmesh.Has noticed recurrence of incarcerated hernia to l of midline.Apparently just below the edge of old mesh.Ct (b)(6) showed loop of small bowel protruding out of hernia.Presented to emergency room (b)(6), date admitted, c/o pain and nausea.A several cm mass was present at level of umbilicus to l of midline.Successful in reducing at least most of this mass, he had resolution of symptoms.Abdomen: hernia is protruding once again, still soft.Impression: current ventral incisional hernia.Plan: ventral herniorrhaphy with mesh.(b)(6) 2004: (b)(6).(b)(6), md.Operative report.Preop dx: multiply-recurrent ventral repair.Postop dx: incarcerated recurrent ventral hernia.Procedures: prosthetic mesh repair, recurrent ventral hernia.Lysis of adhesions.Description: ¿(b)(6)was brought to the operating room and, after anesthesia was induced, he was prep and drape in the usual manner.A transverse incision was made just to the left of midline and just below the umbilicus.Adequate skin bridges were left between the medial end of the incision and the old midline scar.This was centered directly over the location of the protruding hernia.Sharp dissection was carried down a thin layer of grossly-normal fat.The partially-empty hernia sac was identified and, with sharp and cautery dissection, was freed from the subcutaneous fat.Virgin fascia on the inferolateral edge of the hernia defect was identified and i dissected medially, clearing fascia up to the edges of the defect.The apex of the sac was opened and a loop of small bowel was adherent into it.I think that, when he first presented to the emergency room, there had been a loop incarcerated which i had been able to reduce.The excess sac was debrided.Adherent small bowel into the sac was freed with sharp dissection.I found loops of small bowel adherent (nearly circumferentially) around the defect.In a couple of places, it was adherent to the spiral tacks that had been used on a previous laparoscopic repair.With some very tedious dissection, the bowel was freed from these tacks without causing any perforation.There was also adherent bowel around the inferior edge of the defect which did not appear to have been involved with any mesh previously.The hernia defect had protruded through along the inferolateral corner of the old piece of mesh.An 8x10 cm oval patch of dual mesh was trimmed, after the defect was measured.With cautery dissection, the scarred subcutaneous fat medially was freed from the fascia.The mesh was sutured in place in the peritoneal cavity, taking full-thickness mattress sutures of 0 prolene through either the native fascia below or the mesh above.I overlapped the edges of the defect 4-5 cm in each direction.The actual size of the defect was only about 20x25 mm.The field was irrigated; no bleeding was seen.The fascia on the lower edge of the defect was sutured to the edge of the old mesh along the upper edge using interrupted prolene; this closed without tension and buckling the new mesh beneath.A jackson-pratt drain was placed in the subcutaneous space.The subcutaneous fat was closed with running vicryl and the skin was closed with staples.¿ (b)(6) 2004: (b)(6).Intraop record.Surgeon: (b)(6), md.Wound class 1-clean.Implants: gore tex dual mesh.Site: abdomen.Manufacturer: gore-tex.Model #: 15.0cm x 19.0cm x 1.0mm.Lot #: 02731421.Catalog #: 1dlmcp04.Exp date: 10/22/2005.(b)(6) 2004: (b)(6).(b)(6).Op note.Implant sticker.Dualmesh plus antibicrobial.Lot: 02731421.Item: 1dlmcp04.¿repair of recurrent ventral hernia.Intraperitoneal dualmesh 8 x 10 cm patch overlapping l inferolateral corner of old mesh where bowel protruded.Lysis of adhesions circumferentially.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/02731421) was implanted during the procedure.(b)(6) 2004: (b)(6).Nurse notes.Jp d/c¿d [without] difficulty.Dsg [changed] over incision.Skin staples intact and edges of wound well-approx, healing [without] drainage.Sterile 4 x 4¿s placed over incision and jp site, taped in place.(b)(6) 2004: (b)(6).(b)(6), md.Discharge summary.Admit date: (b)(6) 2004.Dx: incarcerated recurrent ventral incisional hernia.Hospital course: previous large herniorrhaphy.Had recurrence at what appeared to be l inferolateral corner of that repair.At surgery, i found a hernia protrusion just along the edge of the old mesh.Bowel was adherent into the sac.It was dissected free and a sizable patch of intraperitoneal prosthetic mesh was placed overlapping old mesh.Postop, did well.(b)(6) 2004: (b)(6).Discharge instructions.Wound/incision care: bandage, change if wet or soiled.No shower until friday.No tub baths, hot tubs, swimming until dr.Okays.Activity: walking, standing, wt.Bearing as tolerated.No lifting more than 25 # till dr.Okays a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient code / codes (1695, 2240, 3191: no code available used for ¿mesh failure¿) was/were reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span october 28, 1998 through june 12, 2018 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from october 30, 1998 through july 12, 2001; from august 26, 2004 through december 2, 2010 were not provided.Patient information: medical history: smoker, hypercholesterolemia, obesity: on (b)(6) 2012: 218.6 lbs; bmi 30.49, diverticulitis.Prior surgical procedures: diastasis recti repair and multiple subsequent hernias [date unknown].On (b)(6) 1995: ventral / umbilical hernia repair, on (b)(6) 1998: repair of recurrent ventral hernia, on (b)(6) 2001: recurrent incisional hernia x2, on (b)(6) 2002: recurrent incisional hernia.Relevant medical information: on (b)(6) 1998: repair of recurrent ventral hernia: ¿he has had a hernial repair about ten or twelve years ago.This was done in california.Supposedly he had a significant component of the hernia above the umbilicus.Part of this was also diastasis according to the records from the previous surgeon.He also had an umbilical hernia repair, repaired with a few stitches of prolene.This has all recurred and he now has a 5-6 cm.Defect very clearly palpable below the umbilicus.Most of this seems to be to the right of midline.¿ records indicate a primary hernia repair utilizing vicryl suture.On (b)(6) 2001: ¿small hernia defect at top of midline incision just below the xiphoid area.Just to right of umbilicus, another defect.¿ on (b)(6) 2001: repair of ¿recurrent hernias times two¿ ¿[the patient] is a 44 year old gentleman that had a big operation as a child.He has had hernias related to this.I repaired a hernia about four years ago in the lower abdomen.He now has a hernia in the right periumbilical area and also a small detect [sic] in the superior portion of the midline incision near the xiphoid.We plan repair.We will try and do primary repairs as indicated.Previous primary repair has held up nicely.¿ records indicate a primary repair utilizing maxon suture.Implant 1 & 2 preoperative complaints: on (b)(6) 2002: ¿hpi [history of present illness]: had a ventral hernia repair in 1992, subsequent recurred.Was re-repaired in 1999, recurred again, fixed a third time in 2001.As far as we know, mesh has never been used.Having painful symptoms around rim of major part of the hernia and desires repair.Abdomen: lengthy midline scar.Mid part of scar has undergone a fascial dehiscence revealing a 5-6 cm fascial defect.Large sac is present, reducible.Thickening superiorly which may harbor more incisional hernias, but difficult to feel.¿ ¿plan: laparoscopic repair, recurrent incisional hernia.Discussed potential complications with regards to recurrence and infection.I indicated that with port placement should there be a visceral injury or hemorrhage present we may need to convert to open procedure or should there be severe adhesions present it may need to be open.This may limit use of mesh.¿ implant 1 & 2 procedure: laparoscopic repair of a recurrent incisional hernia with mesh.Implant: gore® dualmesh® plus biomaterial (01233368 / 1dlmcp04) 15 x 19cm, oval and gore® dualmesh® plus biomaterial (01310995 / 1dlmcp07) 20 x 30cm.Implant 1 & 2 date: on (b)(6) 2002.Records, including the operative note detailing the description of the hernia being treated, implant size, location, fixation and the specific intraoperative findings of on (b)(6) 2002 procedure, were not provided.Post-operative period: [four days].On (b)(6) 2002: post-operative note: ¿multiple defects over an area 15 x 7 cm; omental adhesions in sac.¿ ¿complications: [none].¿ on (b)(6) 2002: phone note: [the patient] ¿underwent laparoscopic repair of multiple incisional hernias today.Adhesions were extensive and required some time for lysis.The total area involved was 15 x 7 cm and a large patch was placed over this without difficulty.¿ on (b)(6) 2002: ¿pod [post-operative day] #1.Temp 100.8.Abd [abdomen] distended, tender only over wounds and patch.Wound sites all look fine.¿ on (b)(6) 2002: ¿pod #2.Temp generally [down], 100.Tenderness [decreased], port sites ok; hernia sac full of fluid.¿ on (b)(6) 2002: ¿pod #3.Temp to 101.Tenderness over edges of patch; a little erythema over hernia sac.Ab¿s [antibiotics] started last night.¿ relevant medical information: on (b)(6) 2002: operative progress note: ¿repair of recurrent ventral hernia.Intraperitoneal dual mesh 8x10 cm patch overlapping l [left] inferolateral corner of old mesh where bowel protruded.Lysis of adhesions circumferentially.¿ on (b)(6) 2002: ¿wounds healing well.If there is a seroma, it is not very palpable, we have elected not to try and reaspirate.¿ on (b)(6) 2002: ¿last week noticed painful symptom inferiorly.Area where most inferior anchoring stitch should be.States it is tugging, pulling, causing sharp pains.Pain is not always in this location and is sometimes around the patch itself.¿ on (b)(6) 2002: ¿10 days postop.Spent couple days in hospital with some fever.Wounds healing well, removed staples.Aspirated a 35 ml seroma from the larger of the hernia sacs.Plans to return to work in a week or 2.¿ on (b)(6) 2002: ¿continues to have pain at lower aspect of site.Primarily over the most inferior anchoring stitch.Discussed options of observation, injections and removing stitch (the last may predispose this patch to migrate out through the defect).He agreed to injection today.I injected this area with 5 mm [sic] 1% xylocaine with epinephrine.Seemed to have relief.¿ on (b)(6) 2002: ¿repair continues to be intact.Painful systems 80% improved with injection.I have re-injected this area, at his request with 5 ml 1% xylocaine.¿ on (b)(6) 2002: ¿wounds continue to be well healed, repair is intact.States as long as he takes vioxx, he can work and do whatever he wants without problems.¿ on (b)(6) 2003: ¿he just got through putting out 3 sacks of feed for the deer.Repair is intact.¿ implant 3 preoperative complaints: on (b)(6) 2004: ¿has noticed a bulge to l and lower of his repair.Appears to be recurrence here.¿ on (b)(6) 2004: ct a/p [abdomen / pelvis]: ¿l infraumbilical hernia sac.The hernia occurs along the inferior margin of the coil-like structures of the mesh-like substance from previous hernia repair.Majority of mesh is in the supra-umbilical region and this area appears to be intact.Hernia sac contains a small bowel loop which has a relatively unremarkable appearance.There appears to be mild fatty infiltration of liver.¿ on (b)(6) 2004: ¿gastroenteritis with vomiting, diarrhea.Then constipation, eventually passed hard stools with some blood on tissue." ¿has had 5 recurrent hernias, 5th surgery pending on (b)(6).All abdominal wall hernias, apparently started with umbilical hernia as child.¿ on (b)(6) 2004: x-ray abd: ¿changes consistent with previous hernia surgery noted.There is air and stool to region of rectum.Impression: changes may represent a gastroenteritis although early small bowel obstruction could also give this appearance¿ on (b)(6) 2004: ¿the patient is a 47-year-old man with a history of multiple previous ventral hernia repairs.He is unclear about the origin operation that resulted in the hernia; dr.(b)(6) felt that it was most likely an attempted repair of diastasis recti.The most recent hernia repair was a laparoscopic herniorrhaphy by dr.(b)(6) two years ago.Dr.(b)(6) described a long, extensive procedure, with a lot of omenta and bowel adherent to the abdominal wall.Multiple defects were repaired with a large intraperitoneal sheet of dualmesh.In recent weeks, the patient has noticed a recurrence of the incarcerated hernia to the left of the midline.This is apparently just below the edge of the old mesh.¿ ¿(ct) scan on (b)(6) showed a loop of small bowel protruding out of this hernia.¿ ¿the patient presented to the emergency room on (b)(6), which is the date he was admitted with complaints of pain and nausea.A several-centimeter mass was present at the level of the umbilicus to the left of the midline.I was successful in reducing at least most of this mass, and he had resolution of his symptoms.His white blood cell count in the emergency room on (b)(6) was 16,000; it had dropped to normal by the following morning.¿ ¿the abdomen is soft and nontender.This morning the hernia is protruding once again, but is still soft.There are no other masses or hernias noted.¿ ¿impression: current ventral incisional hernia.Plan: ventral herniorrhaphy with mesh.¿ implant 3 procedure: prosthetic mesh repair, recurrent ventral hernia.Lysis of adhesions.Implant: gore® dualmesh® plus biomaterial (02731421 / 1dlmcp04) 15 x 19cm, oval.Implant 3 date: on (b)(6) 2004.Description of hernia being treated: ¿a transverse incision was made just to the left of midline and just below the umbilicus.Adequate skin bridges were left between the medial end of the incision and the old midline scar.This was centered directly over the location of the protruding hernia.Sharp dissection was carried down a thin layer of grossly-normal fat.The partially-empty hernia sac was identified and, with sharp and cautery dissection, was freed from the subcutaneous fat.Virgin fascia on the inferolateral edge of the hernia defect was identified and i dissected medially, clearing fascia up to the edges of the defect.The apex of the sac was opened and a loop of small bowel was adherent into it.I think that, when he first presented to the emergency room, there had been a loop incarcerated which i had been able to reduce.The excess sac was debrided.Adherent small bowel into the sac was freed with sharp dissection.I found loops of small bowel adherent (nearly circumferentially) around the defect.In a couple of places, it was adherent to the spiral tacks that had been used on a previous laparoscopic repair.With some very tedious dissection, the bowel was freed from these tacks without causing any perforation.There was also adherent bowel around the inferior edge of the defect which did not appear to have been involved with any mesh previously.The hernia defect had protruded through along the inferolateral corner of the old piece of mesh.¿ implant size and fixation: ¿an 8x10 cm oval patch of dual mesh was trimmed, after the defect was measured.With cautery dissection, the scarred subcutaneous fat medially was freed from the fascia.The mesh was sutured in place in the peritoneal cavity, taking full-thickness mattress sutures of 0 prolene through either the native fascia below or the mesh above.I overlapped the edges of the defect 4-5 cm in each direction.The actual size of the defect was only about 20x25 mm.The field was irrigated; no bleeding was seen.The fascia on the lower edge of the defect was sutured to the edge of the old mesh along the upper edge using interrupted prolene; this closed without tension and buckling the new mesh beneath.¿ post-operative period: [two days].On (b)(6) 2004: discharge summary: ¿previous large herniorrhaphy.Had recurrence at what appeared to be l inferolateral corner of that repair.At surgery, i found a hernia protrusion just along the edge of the old mesh.Bowel was adherent into the sac.It was dissected free and a sizable patch of intraperitoneal prosthetic mesh was placed overlapping old mesh.Postop, did well.¿ relevant medical information: on (b)(6) 2004: ¿2 ½ weeks post repair of focal recurrence of previously repaired ventral hernia.Incision clean, healing well.Wants to know when he can return to work.Managerial position at wal-mart, he can go back at any time.Will remove staples, to return prn only.Cautioned him to avoid heavy lifting for another month.¿ explant 1&2 preoperative complaints: on (b)(6) 2010: [the patient] ¿is now 54.He is a remote patient.He had a big huge incisional hernia or diastasis operation or something many years ago.He advised me and i don't have the records from this so it has been at least seven years and we have thinned our charts, that i repaired a recurrent incisional hernia in the lower abdomen.He now has diastasis recti and probably hernia in the epigastric area of a long midline incision.¿ ¿social history: no alcohol, no tobacco use but he use [sic] to smoke a lot and i suspect that he was smoking during that period of time when he was having these operations done.¿ ¿protuberant body habitus.Long midline incision.Obvious diastasis recti from the umbilicus to the xiphoid and then on the left side feels like there is a hernia defect there.He says this is enlarging over the last six months.Lower abdomen seems ok.¿ ¿we need to see the op notes from his last operations which were done at (b)(6).We will get the narmc records of the operations that i preformed [sic] and then try to decide what is the best course to take.I have advised him that just going in and adding another piece of mesh to the mixture is sometimes very suboptimal.I have advised him also that the potential for incarceration with an epigastric hernia much less than a lower abdomen and that has to do with pressure and gravity and how they affect hernias in general.I don't wish to make any prediction and offer him an operation at this time or even begin to image how we would approach this.We will need to review the records with him.¿ on (b)(6) 2010: ¿has recurrent [ventral] hernias repaired as open procedures with mesh now with new herniation superior to the previous repairs no [surgeries] of bowel incarceration or [surgeries] [sic].¿ ¿no mass, no tenderness, normal bowel sounds (visible and palpable ventral hernia a [sic] epigastrum superior [sic] to the umbilicus defect 6 x 4 cm reducible and nttp [nontender to palpation] inferior abd without evidence of herniation no inguinal masses skin ok.¿ explant 1&2 procedure: laparoscopic lysis of adhesions, taking 45 minutes.Laparoscopic incisional hernia repair utilizing 15 x 20-cm atrium dual-layer mesh.Explant 1&2 date: on (b)(6) 2010.¿findings are that of an incisional hernia involving the mid epigastrium just to the left of the midline.There were three adjacent defects of the fascia, which were somewhat fenestrated in orientation.The defects each were approximately 2-3 cm in diameter.There was incarcerated omentum within the defects and incarcerated loop of bowel within the defect.There was an extensive amount of adhesions from previously placed mesh from previous incisional hernia repairs.There was no evidence of bowel compromise.¿ ¿with careful blunt and sharp dissection, 45 minutes almost to an hour were spent taking down anterior abdominal wall adhesions and small bowel adhesions.This sequentially was performed until the defects were able to be visualized and the incarcerated contents carefully reduced.After reducing the incarcerated defects, the falciform ligament was freed superiorly, and the membranes of the hernia defects as a hernia sac were sharply resected.Then transabdominal passage of a 22-gauge spinal needle was utilized to orient the defects for measurement of their size.After this was accomplished, a 15 x 20-cm dual-layer atrium mesh was selected, and the mesh was appropriately marked and then furled.An 0 vicryl suture was placed on the anterior portion of the mesh at the site for the transabdominal fixation.¿ ¿wound class: ii clean contaminated.¿ records indicate a non-gore device was implanted during on (b)(6) 2010 procedure.Relevant medical information: on (b)(6) 2010: ¿this is a 54-year-old patient who has had previous midline abdominal wall hernia repairs attempted in the past and now has a recurrent symptomatic epigastric ventral hernia.He underwent laparoscopic approach and was noted to have three adjacent fascial defects.This was repaired with a dual-layer atrium mesh underlay technique.Postoperatively, he was progressing and at time of discharge was accepting a diet, was ambulating, and wounds were healing in adequately.¿ on (b)(6) 2011: ¿this is a 54-year-old patient who almost three weeks ago i operated on for an incarcerated epigastric ventral hernia.This was repaired laparoscopically with an underlay repair of dual-layer atrium mesh 15 x 20 cm.He had been seen in the office postoperatively and was recovering satisfactorily.The patient then presented to the emergency room in (b)(6) when he noted that he had an acute episode of swelling and erythema and some discharge from his suture wound.He was transferred over here and was found to have evidence of a draining abdominal wall abscess.He denies any changes in his bowel habits and no generalized abdominal pain otherwise.¿ ¿he has healed laparoscopic incision lines along the right lateral abdomen.The abdomen itself is relatively soft and nontender.No peritoneal irritation is elicited.Along the epigastrium in the central portion of the abdomen at the site of his hernia sac area, this area is inflamed and erythematous and intermittently drains some purulent-appearing fluid.It is not particularly tender.No skin compromise is noted otherwise.¿ on (b)(6) 2011: exploratory laparotomy with drainage of abdominal wall abscess with explantation of previously placed ventral hernia repair mesh ¿findings were that of a [sic] abscess involving drainage through a small suture placement wound of the midline overlying the hernia repair.Opening this revealed a foul smelling abscess with golden colored drainage emanating from this.Multiple cultures were taken.This involved the space between the mesh and the fascia.The fascia was totally disrupted away from the parietal fascial margin.Explantation of the mesh did not reveal any evidence of enteric fistula or bowel compromise.No other extension of abscesses were seen, other than a localized area in front of the mesh.¿ ¿midline incision directly over the previous incision line was taken down and the abscess cavity was entered readily.A transversely oriented incision was extended to the right of the midline and 1 to the left of the midline overlying the 2 subcutaneous hernia site pockets to afford exposure and drainage of these areas.The underlying mesh was carefully evaluated and was noted to be almost completely disrupted and free floating within the abdomen.It was removed intact without difficulty.The wound was copiously irrigated with normal saline and evaluated and specifically there was enteric source searched for and none was found.The bowel was noted to be intact.Therefore, the wound was left open with white sponges and black overlying sponges for the vac dressing were put in place.¿ records do not indicate any of the previously implanted gore devices were explanted during on (b)(6) 2010 procedure.On (b)(6) 2011: ¿entry 1: incision and drainage.Wound class: iv dirty / infected.Entry 2: exploratory laparotomy.Wound class: iv dirty / infected.¿ on (b)(6) 2011: microbiology: ¿removed abd mesh.¿ ¿final report: sparse methicillin resistant staphylococcus aureus; contact isolation required.Moderate growth klebsiella pneumoniae.Moderate growth streptococcus milleir, viridans group.¿ on (b)(6) 2011: pathology: specimen: ¿removed abdominal mesh¿.The specimen consists of three portions of synthetic mesh material and portions of suture material also present.The fragments of mesh measure 29 x 15.2 x 0.4 cm in aggregate.Metallic springs are also present throughout the specimen.No tissue is present and no sections are submitted for histologic examination.¿ on (b)(6) 2011: operative wound exploration and washout ¿the patient two days previously had abdominal wall abscess drained with explantation of ventral hernia repair mesh.He was growing multiple species noted on the gram stain, and klebsiella was beginning to be identified as well.No enteric source had been identified.He had been managed with a vac dressing, and after institution of adequate anesthesia, the vac dressing was removed.The wound was prepared with betadine and draped with sterile drapes.Exploration of the wound did not reveal any evidence of an enteric source or fistulization.No extension of abscess cavities were seen.The wound was recultured, and with the pulsavac lavage apparatus, the wound was copiously irrigated and cleaned.The initial intent was to evaluate to see if the fascia could be dealt with, and it was another period of further wound management before primary definitive closure of his fascial defect.Thus, a new vac dressing was applied, and he was taken to the recovery room in good condition.¿ on (b)(6) 2011: microbiology: ¿organism 1: klebsiella pneumoniae light growth.Organism 2: group f strep (beta hemolytic) light growth.Organism 3: coag negative staphylococcus rare growth.¿ on (b)(6) 2011: abdominal wound exploration with closure of abdominal wound with technique of underlay of 16 x 6-cm biologic allomax mesh technique surgical documentation.Entry 1: exploratory laparotomy.Wound class: ii clean contaminated.¿the wound was carefully evaluated and the previous drainage and lavage procedures and placement of the wound vac had resulted in healthy-appearing granulation tissue and no evidence of residual infection or purulence.Again, a source for enteric communication was searched for and none was identified.The patient had been previously tolerating oral diet intake.The fascial margins had lost some of their stiffness and were noted to be able to be approximated in the midline and thus allomax mesh 16 x 6-cm was selected and as an underlay technique, was secured transfascial with prolene suture out beyond the margin of the fascial wound.After this was accomplished, the fascia itself was closed overlying the mesh with interrupted 0-prolene suture.¿ records indicate a non-gore device was implanted during on (b)(6) 2011 procedure.On (b)(6) 2011: ¿upon evaluation, he was taken to the operating room and underwent drainage of the large abdominal wall abscess.The abscess was noted to lie between the mesh and the fascia.There was no evidence of an enteric source for this; specifically, no enteric fistula or bowel compromise was seen.The mesh was explanted and he underwent two procedures to continue cleaning the wound up and allowing the stiffness of the fascia to resolve before primary closure.Then, he was brought back to the operating room and underwent a primary closure of this wound with the assistance of an underlay biologic mesh placement.Several species were noted on gram stain and klebsiella was the predominant organism which had been cultured.¿ on (b)(6) 2011: ¿presented with post-op wound.Jp [jackson pratt] with nil serous drainage finishes antibiotic tomorrow.¿ ¿wound clean no drainage clips out sp [status post] repair intact.¿ on (b)(6) 2011: ¿presented with hernia repair.Noticed a mass left of midline in epigastrum nttp [non-tender to palpation].¿ ¿bulge in epigastrum w/ valsalva c/w [consistent with] with recurrent hernia defect 3 by 4 cm nttp reducible no other hernias or masses felt.¿ on (b)(6) 2012: ¿presented with hernia.Hx of complex ventral hernia with multiple operations for repair infected mesh repair with biological mesh now with expected progressively enlarging hernia superior aspect.¿ ¿normal bowel sounds (visible bulge right of midline superior aspect defect 6 by 6 cm inferior abd to skin ok).¿ on (b)(6) 2012: ct a/p: ¿two anterior abdominal wall hernias containing loops of bowel.Small fat containing left inguinal hernia.¿ on (b)(6) 2012: ¿recurrent ventral hernia repairs mesh infx [infection] etc now with recurrent ventrqal [sic] hernia with incarceration of colon and small bowel no obstruction.¿ ¿repair with mesh may need component [sic] separation.¿ on (b)(6) 2012: mesh underlay repair of recurrent incarcerated incisional hernia findings: ¿the patient had multiple previous midline ventral incisional hernias that were repaired and had a history of a complicated laparoscopic repair and then the mesh became infected and had to be removed.He now presents with multiple fenestrated defects along the medial rectus sheath at and superior to the umbilicus with incarcerated loops of small-bowel within the hernia defects.There is no evidence of bowel compromise.The defects were mainly involved superior to the umbilicus.No other hernia defects were noted after reduction of incarcerated bowel loops.No evidence of bowel compromise was noted.The liver appeared to be normal.The gallbladder was specifically evaluated and noted to be normal in appearance and consistency and no cholelithiasis was palpated.¿ ¿the previous upper midline scar was removed and the incision was carried down to the level of fascial defects, which were sequentially opened.With careful sharp and blunt dissection, the adhered small-bowel and colon loops and omental loops were lysed from the anterior abdominal wall.This allowed visualization of the incarcerated bowel contents and these were carefully reduced from the hernia defects.Each defect was estimated to be approximately 2 to 3.5 cm in diameter.Two were on the right side along the medial aspect of the rectus sheath and 2 were on the left side at the medial aspect of the rectus sheath.After lysis of adhesions was accomplished, the bowel loops were carefully evaluated.No evidence of bowel compromise was seen.The bowel was allowed to lie in its normal anatomic orientation.Then the estimated overall extent of the defect of the anterior abdominal wall was measured.With the multiple fenestrated defects, it was found ethicon proceed dual-layer mesh 15 x 20-cm diameter was selected.This would be placed as an underlay technique.The mesh was secured circumferentially with transfascial sutures of 0 prolene, securing the mesh at a distance of 3 to 4 cm lateral to the hernia defect circumferentially.At least 7 of these transfascial sutures were placed.This was done with the suture passer.Next, the peritoneal resection within the hernia defects were removed and the fascia over the midline was then closed with application of interrupted 0 prolene sutures with ever 3rd to 4th bite grasping and incorporating the anterior margin of the mesh, pulling it up against the abdominal wall.Prior to closure of the fascia, interrupted 3-0 vicryl sutures were sequentially placed to help close any potential windows for migration of bowel up anterior to the mesh.¿ records indicate a non-gore device was implanted during on (b)(6) 2012 procedure and do not indicate any of the previously implanted gore devices were removed.On (b)(6) 2012: pathology: specimen: ¿¿hernia sac¿ are multiple segments of tan-purple membranous tissue and adipose tissue admixed with probable mesh which measure 3.5 x 3 x 1.5 cm in aggregate.The specimen is serially sectioned and no obvious abnormalities are identified.¿ on (b)(6) 2012: ¿mesh underlay repair of recurrent ventral hernia.History and hospital course: this is a 55-year old patient who i had operated previously for complex ventral hernia repair.He underwent a laparoscopic repair at that time, but then developed a mesh infection.This required return to the operating room and removal of the mesh.His persistent ventral hernia now has become more apparent and he is brought back to the operating room, and underwent a mesh underlay repair of his ventral hernia.Postoperatively, he progressed satisfactorily.¿ on (b)(6) 2012: ¿no redness or drainage.(1/2 clips removed slight show of old blood seroma drainage superior wound no purulence [sic]).¿ on (b)(6) 2012: ¿no redness or drainage (repair intact abd strong).¿ on (b)(6) 2014: ¿recurrence of large complex abdominal wall hernia no pian [sic] no ttp.¿ ¿had multiple hernia surgeries infected wounds etc now with recurrence of mid to low abd wall hernias will need a ct scan of the abd wall to assess what we are dealing with.¿ on (b)(6) 2014: ct a/p: ¿interval enlargement of ventral abdominal wall hernia with neck of hernia measuring 7.4 x 10.2 cm in transverse and cephalocaudal dimension.Multiple compartments within hernia sac in anterior abdominal soft tissues.Hernia contains small bowel loops, non-obstructed.¿ on (b)(6) 2017: ¿has a giant ventral hernia with partial loss of domain.Is here to talk about trying to [sic] referred to (b)(6).¿ ¿incisional hernia.Is interested and [sic] some form of developmental research on reconstructive prosthetics for hernias wants me [sic] derive a cover letter to her [sic] research director at (b)(6) regarding this subject told him that the research interested is fine.Does not address the problem of giant ventral hernia which she [sic] will have to go to a hernia center to have this addressed.¿ on (b)(6) 2018: ¿has had 10 abdominal surgeries-all by dr.(b)(6) in nwa-for various hernia repairs / revisions / mesh infection.Last operation was about 3 years ago.Supraumbilical hernia repair remains intact, however, has 3 large hernias in lower abdomen.Is asymptomatic from these hernias, however, states he has a long life to live and that they need to be taken care of.Understands that he¿s 25 pounds overweight and believes he will be able to lose the excess weight when hernia is repaired.Last ct was about 3 years ago.Has been told about dr.(b)(6) reputation and would like him to perform the repair.Has been told that plastic surgery will need to be involved in repair for cosmetic reasons.Of note, would like to discuss an idea he has for a new type of hernia repair with the uams research and development department.Would not say what it entails but states knows many meshes are made overseas in (b)(6) and president (b)(6) stated he would expedite studies through the fda that would save a life.¿ on (b)(6) 2018: ¿many recurrences and mesh infections in the past.Has an idea for an experimental hernia repair system which is what he wishes to discuss in clinic today.Hernia defect is very large and am afraid he would possibly have a long time on the vent or even be dependant [sic] on the vent.Tried to discuss vent dependence, need for a colonoscopy, and needing to get op reports before planning surgery.The only context in which he wishes to discusses his hernia repair is with his system, which he wouldn't discuss with me and that he would need to set up a non-clinical meeting with a willing surgeon (¿in the research département [sic], please¿).Asked for our nurse to discuss with him.Told him i dont do experimental hernia surgery.May follow up in clinic after he¿s decided on a traditional mesh repair or has gotten fda approval for his mesh.¿ due to character / space constraints within the investigation summary field, all of the investigation information could not be included and is therefore being added as a separate attachment and should be referenced for complete investigation summary and conclusions.

Manufacturer Narrative

Updated patient codes; updated device code; updated conclusion codes.Previous patient code/codes (1695, 2240, 3191: no code available used for ¿mesh failure¿) was/were reported, based on the original complaint.And are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation,, there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.The device was not able to be returned to gore for evaluation.Therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified, that the lot met all pre-release specifications.Section c1: name: plus antimicrobial product coating, manufacturer/compounder: w.L.Gore & associates, inc., lot number#: 01310995.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE DUALMESH PLUS BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8065137
• MDR Text Key: 126960513
• Report Number: 2017233-2018-00685
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00733132601141
• UDI-Public: 00733132601141
• Combination Product (y/n): N
• PMA/PMN Number: K063435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2004
• Device Model Number: 1DLMCP07
• Device Catalogue Number: 1DLMCP07
• Device Lot Number: 01310995
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 91