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

W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Model Number 1DLMCP06

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

Patient Problems Adhesion(s) (1695); Hernia (2240); Not Applicable (3189)

Event Type Injury

Manufacturer Narrative

(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.

Event Description

It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2013 whereby a gore dualmesh®plus biomaterial was implanted.It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2015 whereby a gore dualmesh®plus biomaterial was implanted.It was reported the patient alleges the following injuries: additional surgery, lysis of adhesions, recurrent incarcerated incisional hernia repair.Additional event specific information was not provided.

Manufacturer Narrative

Corrected results code.Conclusion code remains unchanged.

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: records prior to (b)(6) 2013, including records for hysterectomy, appendectomy and laparoscopic cholecystectomy were not provided.(b)(6) 2013: office notes.Hpi: 3 month h/o abdominal bulging, 9 month h/o abdominal pain relieved with bm.Exam: large midline abd hernia.Plan: dr.Sharon schaefer-general surgeon, eval abd hernia.(b)(6) 2013: office notes.Cc: periumbilical, epigastric discomfort, possible hernia.Over last six months, lost almost 50 pounds.Noticed bulge above umbilicus, seems to be getting larger as continues to lose weight.Exam: abdomen obese, wt 217, little bit of a bulge at periumbilical incision.Diastasis recti when sits up.Mass in mid to upper abdomen.The hernia is in the midline and the mass seems to expand laterally on both sides.This is [sic] hernia, i do not think.I am not sure what is the physical exam finding completely.Cat scan of abdomen and pelvis to help delineate the hernia versus diastasis question.If there is a mass this will help [sic] that diagnosis.Impression: incisional hernia with obstruction, abdominal pain periumbilic.(b)(6) 2013: radiology ct abdomen/pelvis.Indication: diastases rectus, hernia.Findings: abdominal wall hernia in midline just superior to umbilicus.Does contain a loop of bowel.No obstruction.Also a bochdalek type hernia through posterior right hemidiaphragm which contains fat only.Impression: prominent cystic mass in the pelvis and abdomen with internal septation.Anterior abdominal wall hernia.Right-sided bochdalek hernia.(b)(6) 2013: office notes.Impression: incisional hernia with obstruction, other and unspecified ovarian cyst.Plan: repair initial incisional or ventral hernia; incarcerated or strangulated.Implantation of mesh or other prosthesis for open incisional or ventral hernia repair or mesh for closure of debridement for necrotizing soft tissue infection.(b)(6) 2013: history and physical.Hpi: surgery august 9 for removal of ovarian cyst/mass and repair of the incarcerated incisional hernia.Exam: abdomen: positive bowel sounds, large mass in pelvis above umbilicus.Above the umbilicus is laparoscopic incision that has an additional bulge that does not reduce.Impression: dr.Oliver, removal of cyst with a salpingo-oophorectomy, then incarcerated incisional hernia repaired.(b)(6) 2013: pathology report.Accession #: s13-071802.Final diagnosis: right ovary and fallopian tube, salpingo-oophorectomy: mucinous cystadenoma.Peritoneal washings (2 cytospins and cell block): reactive mesothelial cells, blood and occasional neutrophils.Negative for cytologically malignant cells.Incisional hernia: congested and chronically inflamed hernia sac.Clinical information: received in formalin, labeled ¿ethel neel¿ ¿incisional hernia sac¿, are two portions of fibrofatty tissue that measure 7x 3 x2 cm.There are no white hard masses or focal lesions see.Representative sections are placed in cassette c1.(b)(6) 2013: office notes.Abdomen: the vertical midline incision is healing well.There is no fluctuance of sign of infection.The staples are removed and steri-strips are placed.(b)(6) 2015: office notes.Assessment: incisional hernia with obstruction.Plan: laparoscopy, surgical, repair, recurrent incisional hernia (includes mesh insertion, when performed); incarcerated or strangulated.(b)(6) 2015: history and physical.30-pound weight gain, noticed new bulge in the abdomen.This is at the upper aspect of her incision, which is also close to the umbilicus.Cat scan, recurrent incarcerated incisional hernia found.This contained a loop of transverse colon.There was no bowel obstruction.In addition, a complex left ovarian cyst identified.Now for attempt at laparoscopic left oophorectomy and laparoscopic repair of the recurrent incarcerated incisional hernia with mesh.Physical exam: abdomen: obese, soft.There is a bulge at the midline around the umbilicus.This is not reduced.(b)(6) 2016: discharge summary.Principal diagnoses: incarcerated incisional hernia.Left ovarian mass/cyst.Complications: bilateral pneumonia.Acute renal failure.Rhabdomyolysis.Toxic metabolic encephalopathy.Acute blood loss anemia.Hyperkalemia.Summary: presented with recurrent incarcerated incisional hernia.This was superior to previously placed mesh.Cat scan, found to have a left ovarian cyst in an area where it was believed that she had already had salpingo-oophorectomy.Abdomen was soft with a bulge at the midline around the umbilicus that did not reduce well; in fact it did not reduce at all.There was no associated erythema, fluctuance, or sign of infection.The patient was offered attempt at laparoscopic repair with the knowledge that we might have to convert to an open procedure, so on the day of surgery, she was taken to the operating room and indeed we did have to convert to open incarcerated recurrent incisional hernia repair with mesh.Dr.Oliver was able to perform the left salpingo-oophorectomy.On the first postoperative day, she had minimal pain.By the second postoperative day [sic] had become confused.She had developed bilateral pneumonia, acute renal failure had set in along with rhabdomyolysis, and these all led to toxic metabolic encephalopathy.The hospitalists were consulted and they assisted greatly in her care.Levaquin and flagyl were started.By postoperative day #4, acute renal failure had essentially resolved along with rhabdomyolysis.Was maintained on iv antibiotics.Toxic metabolic encephalopathy had resolved.It was advised that she continue the antibiotics for a total of 7 days.By [sic], she was having bowel function.She was advanced to regular diet.She had walked in the hallway, eating a regular diet, abdomen was soft, incision was fine.She still had a jp in place, which was draining 40+ ml per 24 hours.She had instructions to continue her home medications including eliquis.She was to continue levaquin 500 mg p.O.Every day for 3 more days.She was also given prescription for flagyl.Advised to use the abdominal binder.(b)(6) 2016: office notes.Abdomen: the vertical midline incision is healing well, no fluctuance or sign of infection.Some staples removed, steri-strips placed, drain removed.Some erythema inferior aspect of incision and around the jp exit site.Plan: paint wound area with betadine once or twice a day.(b)(6) 2016: office notes.Abdomen: vertical midline incision healing well, no fluctuance, no erythema in the incision, no recurrent hernia.(b)(6) 2016: office notes.Abdomen: vertical midline incision healing well, no fluctuance, no erythema in the incision, no recurrent hernia.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.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

Other relevant history: 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: records prior to 8/9/2013, including records for hysterectomy, appendectomy and laparoscopic cholecystectomy were not provided.Operative records dated 8/9/2013 indicate the patient underwent incarcerated incisional hernia repair with mesh, right salpingo-oophorectomy.¿a vertical midline incision was made from above the some incisional hernia to several centimeters below the umbilicus.Dissection was carried down through the skin and subcutaneous tissue.The hernia sac was identified first in the upper abdomen.This was dissected free from the surrounding subcutaneous tissue.The hernia sac was opened and the abdomen entered.The herniated incarcerated contents were reduced back into the abdomen after the fascia opening was opened further.Adhesions to the undersurface of the abdominal wall were taken down.There were just a few.Attention first was turned to the large right ovarian cyst.¿ the records dated (b)(6)2013 confirm a gore dualmesh®plus biomaterial (1dlmcp05/10960364) was used during the procedure, however, the complete operative report detailing the procedure were not provided.Discharge summary records for hospital stay dated (b)(6)2013 to (b)(6)2013 state: the patient ¿¿is a 76-year-old female, whose weight had changed from (b)(4) pounds to 217 over the last few months.She began to notice a bulge in the upper abdomen in the site of a previous surgery.Because of some firmness in the abdomen on exam, a cat scan was performed on (b)(6)2013.The incarcerated incisional hernia was present in the midline with a loop of small bowel contained within it.In addition, she had an 18 cm, prominent, cystic mass associated with the right ovary.¿ the(b)(6)2013 discharge summary records state: ¿she had an uneventful postoperative course with gradual resumption of bowel function, advancement to regular diet, and transition from iv pain medications to oral medications.¿ ¿on august 13, she was desirous of discharge.She tolerated her breakfast, though she had vomited the night before.Her abdomen had positive bowel sounds.The abdomen was soft and had some incisional tenderness.¿ records between(b)(6)2013 and (b)(6)2015 were not provided.Operative report dated (b)(6)2015 indicates the patient underwent laparoscopic converted to open incarcerated recurrent incisional hernia repair with mesh, open extensive lysis of adhesions, left salpingo-oophorectomy.Operative finding state: ¿incarcerated recurrent incisional hernia with incarcerated transverse colon, just superior to the previously placed mesh.Three other small fascial defects to the right of the upper midline.The left ovary was seen with a moderate-sized cyst, many adhesions.The operative records dated (b)(6)2015 state: the patient ¿¿is a 79-year-old, who we operated on before for a large right ovarian cyst and hernia about 2 or 3 years ago.At that time, we saw no left ovary and we were planning to remove it if we found it and her history was that supposedly the ovary had been removed, but now she came in recently complaining of abdominal pain and so i ordered a ct scan and it showed this recurrent incisional hernia with a large transverse colon incarcerated into it, so i sent her back to dr.Schaefer and we brought her to the operating room for procedure.¿ the operative records dated (b)(6)2015 state: ¿numerous adhesions were noted at the midline, in the right lower quadrant, and in the right upper quadrant.The space could not be developed for placement of another trocar.Ilooked for several minutes for an opening and none was identified.Therefore, the procedure was converted to an open procedure.¿ the records dated (b)(6)2015 continue: ¿her previous vertical midline incision was opened and dissection carried down through the skin and deep subcutaneous tissue to the fascia.The small fascial opening in the midline was identified with air in the peritoneum.This was opened.The defect was about 3 cm.The loop of bowel was larger and was noted to go to the right at the midline.The hernia was reduced.A fair amount of time (about 2 hours) was used for lysis of adhesions to take the omentum and small bowel down from the anterior abdominal wall.¿ operative records dated (b)(6)2015 state: ¿dissection was carried down into the left pelvis.Dr.Oliver then assumed care of the patient and performed the left salpingo-oophorectomy.I then assumed care of the patient again for further lysis of adhesions.The intraabdominal contents were taken down from the right upper quadrant abdominal wall.Three additional fascial defects were identified.Careful palpation revealed no other defects.The abdominal wall had been cleared of its adhesions.¿ records dated (b)(6)2015 state: ¿a piece of dualmesh plus was chosen, the large piece.This was cut to size and was then secured to the fascia with through-and-through ethibond sutures.The sutures were placed 2 to 3 cm beyond the fascial defects.Each of the 3 small fascial defects just to the right of the midline were also closed before placement of the mesh with figure-of-eight 0 ethibond suture.The larger defect would be closed later above the mesh.¿ operative records dated (b)(6)2015 continue: ¿so a running 0 ethibond suture was used to secure the mesh 2 to 3 cm beyond any fascial defect beginning in the right upper quadrant and extending inferiorly and then another suture was used beginning in the right upper quadrant and going across the midline to the left and going inferiorly.0 prolene was used to reapproximate the inferior fascial opening, which had not contained a hernia.¿ records dated (b)(6)2015 state: ¿the fascia was reapproximated using the 0 prolene suture.A piece of seprafilm was placed under this fascia appeared [sic].The mesh was secured circumferentially to the fascia taking sutures through the entire fascial and muscle layer with each bite.The mesh was noted to lie fairly nicely with minimal wrinkles.The fascial defect overlying the mesh was then closed with 0 ethibond suture.This pulled together fairly well with minimal tension.¿ the records dated (b)(6)2015 state: ¿two round 19-french drains were brought in through separate stab wounds.One was placed on either side of the midline and the subcutaneous tissue, which had been elevated to facilitate placement of the ethibond suture through the fascia.The drains were secured at their exit sites with 3-0 nylon.The subcutaneous tissue was reapproximated with 2 different layers of 2-0 vicryl suture.The skin was closed with skin clips.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmcp06/12771380) was used during the procedure.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: records prior to (b)(6) 2013, including records for hysterectomy, appendectomy and laparoscopic cholecystectomy were not provided.Medical records dated (b)(6) 2013 indicate the patient was seen for ovarian cyst.¿she was referred by sharon schaefer for a large complex right ovarian cyst.Ct scan showed an 18 x 17 x 17 cm septated cyst.Ther [sic] is and abdominal hernia and a bochdalek hernia on the right but there is no lymphadenopathy or ascites fluid.Dr.Schaefer is planning to operate on the patient for the hernias.She had a cesarian hysterectomy in 1970.She had rh sensitization at that time.The ovaries were not removed.¿ operative records dated (b)(6) 2013 state ¿once we were into the peritoneal cavity and had opened up the incision large enough, i was able to pull the cyst up into the incision, but i could not reach back to get to its pedicle, to its attachment.This was not something that would have been solved by an even larger incision.So i finally made the decision to go ahead and drain this cyst, and we wrapped towels all around it and then i made a very small stab and then stuck the sucker right inside of the cyst and collapsed it down.¿ operative records dated (b)(6) 2013 continue: ¿this was a multiloculated cyst, so i actually had to do this several times until i could get it down and expose it well enough to allow me to do the dissection.Then we exposed the infundibulopelvic ligament and i clamped it and transected 1[sic] and tied it with a free tie of 2-0 vicryl.We lysed the peritoneal adhesions to the back side of this ovary and exposed it.I identified the ureter, and this cyst was adherent just over the ureter, and basically we had to unroof the peritoneum over that ureter as we dissected the cyst free.¿ operative records dated (b)(6) 2013 state: ¿once we had this freed up we removed it and sent it off to pathology and they did a frozen section, and the frozen section report was that the sections that they had examined were all benign, no evidence of malignancy.So at this point in time we looked for the left tube and ovary and we could not find any evidence of it anywhere.So while we were waiting for the frozen section reports, dr.Schaefer then did her excision of the hernia sac¿¿ operative records dated (b)(6) 2013 state: ¿once this was all completed the abdomen was closed with the #1 prolene and then the subcutaneous tissue was closed with 2-0 monocryl and the skin was closed with staples.¿ medical records dated (b)(6) 2013 indicate patient was seen for 2wk post op visit.The records state: ¿she is doing well.Dr.Schaefer removed the staples.The pathology showed a benign mucinous cystadenoma.¿ the records also state ¿wound is healing well.¿ records between (b)(6) 2015 were not provided.Medical records dated (b)(6) 2015 indicate the patient was seen for ¿burning pain in lower abd[domen].Assessment: ¿i do not see any masses with the us.I think she needs a ct of the abdomen and pelvis with iv and oral contrast if her renal function is adequate.¿ ct abdomen/pelvis dated (b)(6) 2015 states: ¿there is a fat-containing bochdalek hernia at the right lung base.The hernia sac measures 7cm across.¿ the records state ¿the patient is status post ventral abdominal wall hernia repair surgery.There is a recurrent periumbilical hernia containing a loop of the transverse colon.The hernia sac measures 6.8cm in size.There is no associated bowel obstruction.Extensive diverticulosis is present of the distal colon, particularly the sigmoid section.There are no inflammatory changes of acute diverticulitis, however.There is no abnormal small bowel dilatation.¿ the records also state: ¿complex 3.2 cm left ovarian cyst¿¿ medical records dated (b)(6) 2016 state patient was seen for ¿encounter for surgical aftercare following surgery on the genitourinary system.¿ records state ¿gastrointestinal: abdominal wound is healing well.¿ the records indicate a patient weight of 253 lbs/bmi 46.3.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: 08/09/13: mat-su regional medical center.John r.Oliver, md.History and physical.Hpi: large right ovarian cyst.Abdominal wall hernia, seen by dr.Schaefer.Ros: weight loss of 43 lbs.Over past year.Abdominal pain off and on, heartburn.Exam: bowel sounds present.Mass palpable above umbilicus.Impression: dr.Schaefer does abdominal hernia repair; i will do bilateral salpingo-oophorectomy.08/09/13: mat-su regional medical center.Implant sticker.Gore dualmesh® plus biomaterial 7.5 x 10cm.Lot#: 10960364.Cat#: 1dlmcp05.Site: abdomen.Manufacturer: w.L.Gore.08/10/13: mat-su regional medical center.[provider signature illegible].Progress notes.Pod [postop day] #1.¿ flatus but hungry.Dressings c/d/i [clean/dry/intact].08/11/13: mat-su regional medical center.[provider signature illegible].Progress notes.Pod #2.Pt doing well s/p rso & hernia repair.Tolerating diet.May be ready to go home soon.08/12/13: mat-su regional medical center.[provider signature illegible].Progress notes.Pod #3.Nausea & vomiting last pm.Does not have nausea now but not much appetite.Blisters on buttocks.Afebrile.08/13/13: mat-su regional medical center.[provider signature illegible].Progress notes.Pod #4.Wants to go home! ate breakfast even though vomited during [illegible].Afebrile vss.+bs [bowel sounds].Incisional tenderness.Dressing good.Good progress, home.12/28/15: mat-su regional medical center.John r.Oliver, md.History and physical.Saw in office 12/03/15 complaining left lower abdominal burning pain.Ct abdomen/pelvis showed recurrent hernia 6.8 cm, transverse colon in hernia, also complex cyst in left ovary.Plan to remove this at time dr.Schaefer does hernia repair.If any ovarian tissue to remove, will remove it.12/28/15: mat-su regional medical center.Implant record.Mesh dual plus 18cm x 24cm x 1.Lot#: 12771380.Cat#: 1dlmcp06.Manufacturer: w.L.Gore.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp06/12771380) was implanted during the procedure.12/28/15: mat-su regional medical center.Implant record.Seprafilm genzyme 430102.Site: abdomen.Manufacturer: genzyme.12/28/15: cellnetix.John g.Fink, md.Pathology.Left fallopian tube and ovary.Final dx: benign serous cystadenoma of ovary.Ovary with small inclusion cysts and corpora albicantia.Focally dilated fallopian tube.Negative abscess or malignancy.12/30/15: mat-su regional medical center.Robert p.Finch, md.Consultation.Reason: altered mental status, postop fever.Hpi: hx of cva in 2015.Underwent laparoscopy with lysis of adhesions and recurrent incarcerated incisional hernia repair with mesh and left salpingo-oophorectomy for left ovarian cyst done on 12/28/15.Currently postop day 2.Yesterday doing well, minimal pain.Overnight, change in mental status, became more unresponsive.Will awake at certain times to say yes and no but unable to follow many commands.Elevated wbc 11.1, fever since 3 a.M.This morning.Pt unable to provide hx or any information.Only nurse at bedside.Contacted husband to get information.Pmh: cva 2013.Assessment: has toxic encephalopathy, suspected left lower lobe pneumonia, acute blood loss anemia, hyperkalemia, acute kidney injury with adequate urine output, thrombocytopenia.Placement of pacemaker 2013 and 2014.Plan: ct of abdomen without contrast.Ct with contrast of head to rule out acute hemorrhage or cva.12/30/15: mat-su regional medical center.D.Gregg davenport, md.Radiology¿ct abdomen/pelvis wo.Comparison: ct scan of abdomen/pelvis 12/09/15.Hx: suspected infection status post recent unspecified surgery.Findings: undergone interval repair of recurrent periumbilical hernia.Surgical drains seen with distal tips adjacent to anterior abdominal wall.Subtle stranding density in mesenteric fat subjacent to hernia repair.Cerebral small foci of air lucency in abdominal wall and extraperitoneal soft tissues.No intraperitoneal free air, accumulation of fluid or abscess formation.No drainable seroma or hematoma seen in subcutaneous tissues.Remonstrated is right-sided bochdalek hernia.Impression: pneumonia cannot be excluded in pt who exhibiting signs of infection.No complication of recent ventral hernia repair.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) : (b)(6) medical center.(b)(6) md.Operative report.Pre/postop dx: right ovarian cyst.Abdominal wall hernia.Procedure: right salpingo-oophorectomy by (b)(6) md.Abdominal wall hernia repair by (b)(6) md, and she will dictate her portion of the procedure.Co-surgeons: (b)(6) md, was the surgeon for the laparotomy, for the salpingo-oophorectomy, and sharon k.(b)(6) , md assisted me.(b)(6) md was the surgeon for the abdominal wall hernia repair with mesh and i assisted her.Identification: sent to dr.(b)(6) for abdominal wall hernia, and discovered on ct scan that the patient had a large, 18 cm, ovarian cyst with no ascites or lymphadenopathy or any evidence of metastasis, consulted with me and we came to the operating room for a joint procedure, for me to take out that right tube and ovary and for her to do the abdominal wall hernia repair.Findings: ¿the patient has a large right ovarian cyst that had adhesions posteriorly along where its attachments to the infundibulopelvic ligament were and right over the ureters it went down into the pelvis.Otherwise there were no adhesions to the ovary.We were planning to take out the left tube and ovary, and i could not find it.Her husband said at the time of the cesarean section they had told her they took out both of her tubes and ovaries, so this could explain the location of the adhesions on the right ovary and also why i did not find a left ovary.Procedure: after adequate induction of general anesthesia the patient was prepped and draped in the supine position.Dr.(b)(6) made the incision for the patient¿s abdominal wall and also to expose the hernia sac.Once we were into the peritoneal cavity and had opened up the incision large enough, i was able to pull the cyst up into the incision, but i could not reach back to get to its pedicle, to its attachment.This was not something that would have been solved by an even larger incision.So, i finally made the decision to go ahead and drain this cyst, and we wrapped towels all around it, and then i made a very small stab and then stuck the sucker right inside of the cyst and collapsed it down.This was a multilocuiated cyst, so i actually had to do this several times until i could get it down and expose it well enough to allow me to do the dissection.Then we exposed the infundibulopelvic ligament and i clamped it and transected it and tied it with a free tie of 2-0 vicryl.We lysed the peritoneal adhesions to the back side of this ovary and exposed it.I identified the ureter, and this cyst was adherent just over the ureter, and basically, we had to unroof the peritoneum over that ureter as we dissected the cyst free.Once we had this freed up, we removed it and sent it off to pathology and they did a frozen section, and the frozen section report was that the sections that they had examined were all benign, no evidence of malignancy.So, at this point in time we looked for the left tube and ovary and we could not find any evidence of it anywhere.So, while we were waiting for the frozen section reports dr.(b)(6) then did her excision of the hernia sac and she will dictate the rest of that portion of the procedure.Once this was all completed the abdomen was closed with the #1 prolene and then the subcutaneous tissue was closed with 2-0 monocryl and the skin was closed with staples.She was awakened from her anesthesia and taken to recovery room in good condition.There were no complications from procedure.¿ (b)(6) 2013: (b)(6) medical center.(b)(6) md.Operative report.Pre/postop diagnoses: large right ovarian cyst.Incarcerated incisional hernia.Procedure: performed by me with assistance by dr.(b)(6) incarcerated incisional hernia repair with mesh.Dr.(b)(6) was the surgeon and i was assistant: right salpingo-oophorectomy.Findings: incarcerated transverse colon in the upper midline incarcerated incisional hernia.A large right multiloculated ovarian cyst, which was benign by frozen section.Description of procedure: ¿the patient was brought to the operating room and placed in the supine position on the operating table.After adequate general endotracheal anesthesia was obtained, she was prepped and draped in the usual sterile fashion.A vertical midline incision was made from above the some [sic] incisional hernia to several centimeters below the umbilicus.Dissection was carried down through the skin and subcutaneous tissue.The hernia sac was identified first in the upper abdomen.This was dissected free from the surrounding subcutaneous tissue.The hernia sac was opened and the abdomen entered.The herniated incarcerated contents were reduced back into the abdomen after the fascia opening was opened further.Adhesions to the undersurface of the abdominal wall were taken down.There were just a few.Attention first was turned to the large right ovarian cyst.Please see dr.(b)(6) dictation for the care of this.The incisional hernia was a bit off the midline in the upper abdomen, and so the fascia was reapproximated with 0 prolene from the undersurface of the abdominal wall.A piece of dualmesh plus was soaked in antibiotic solution.It was then cut to size and then secured circumferentially around the fascial defect about 3 cm laterally, superiorly and inferiorly and to the midline.The fascia was then closed with superiorly with a 0 prolene sutures to below the fascial defect.The protack-er was then used to secure the mesh across the midline to the left side of the abdominal wall.The mesh was noted to lie nicely.The fascia was then further treated with closure with 0 prolene beginning at the inferior aspect of the fascia opening and coming up to the umbilicus and the sutures were tied together in the middle.The subcutaneous tissue was reapproximated with 2-0 monocryl.The skin closed with skin clips.The incision was washed and dried and dressings applied.The patient was then awakened, extubated, and taken to the recovery room in stable condition.She tolerated the procedure well without complications.¿ 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

Previous patient codes (1695, 2240) were reported based on the original complaint and are no longer applicable per gore¿s investigation.No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.Medical records: the known medical records span (b)(6) 2013 through (b)(6) 2016 and not all records received in this time span are relevant to the gore® dualmesh® plus biomaterial.Records from (b)(6) 2013 through (b)(6) 2015 were not provided.Patient information: medical history: hypertension, mild to moderate aortic stenosis, cerebrovascular accident, former smoker, quit 1989.On (b)(6) 2015: 2 ¿ 3 pack/day x 35 ¿ 40 years, obesity.219lbs; bmi 40.2 on (b)(6) 2013: 217lbs; bmi 39.7; on (b)(6) 2014: 281lbs; bmi 51.4; on (b)(6) 2016: 253lbs; bmi 46.3.Prior surgical procedures: 1970: cesarean section, hysterectomy.1970: appendectomy.1996: laparoscopic cholecystectomy.2009: right knee replacement.Implant #1 preoperative complaints: on (b)(6) 2013: ¿3 month h/o [history of] abdominal bulging, 9 month h/o abdominal pain relieved with bm.Exam: large midline abd hernia.¿ on (b)(6) 2013: ¿over last six months, lost almost 50 pounds.Noticed bulge above umbilicus, seems to be getting larger as continues to lose weight.Exam: abdomen obese, wt [weight] 217, little bit of a bulge at periumbilical incision.Diastasis recti when sits up.Mass in mid to upper abdomen.The hernia is in the midline and the mass seems to expand laterally on both sides.This is __ [sic] hernia, i do not think.I am not sure what is the physical exam finding completely.Cat scan of abdomen and pelvis to help delineate the hernia versus diastasis question.If there is a mass this will help __ [sic] that diagnosis.Impression: incisional hernia with obstruction, abdominal pain periumbilic.¿ on (b)(6) 2013: ct abdomen/pelvis: ¿abdominal wall hernia in midline just superior to umbilicus.Does contain a loop of bowel.No obstruction.Also a bochdalek type hernia through posterior right hemidiaphragm which contains fat only.Impression: prominent cystic mass in the pelvis and abdomen with internal septation.Anterior abdominal wall hernia.Right-sided bochdalek hernia.¿ on (b)(6) 2013: ¿repair initial incisional or ventral hernia; incarcerated or strangulated.Implantation of mesh or other prosthesis for open incisional or ventral hernia repair or mesh for closure of debridement for necrotizing soft tissue infection.¿ on (b)(6) 2013: ¿surgery (b)(6) for removal of ovarian cyst/mass and repair of the incarcerated incisional hernia.Exam: abdomen: positive bowel sounds, large mass in pelvis above umbilicus.Above the umbilicus is laparoscopic incision that has an additional bulge that does not reduce.¿ implant #1 procedure: incarcerated incisional hernia repair with mesh, right salpingo-oophorectomy.Implant: gore® dualmesh® plus biomaterial (10960364/1dlmcp05) 7.5 x 10cm.Implant #1 date: (b)(6) 2013 [hospitalized (b)(6) 2013].Description of hernia being treated: ¿a vertical midline incision was made from above the some [sic] incisional hernia to several centimeters below the umbilicus.Dissection was carried down through the skin and subcutaneous tissue.The hernia sac was identified first in the upper abdomen.This was dissected free from the surrounding subcutaneous tissue.The hernia sac was opened and the abdomen entered.The herniated incarcerated contents were reduced back into the abdomen after the fascia opening was opened further.Adhesions to the undersurface of the abdominal wall were taken down.There were just a few.Attention first was turned to the large right ovarian cyst.¿ implant size and fixation: the incisional hernia was a bit off the midline in the upper abdomen, and so the fascia was reapproximated with 0 prolene from the undersurface of the abdominal wall.A piece of dualmesh plus was soaked in antibiotic solution.It was then cut to size and then secured circumferentially around the fascial defect about 3 cm laterally, superiorly and inferiorly and to the midline.The fascia was then closed with [sic] superiorly with a 0 prolene sutures to below the fascial defect.The protack-er was then used to secure the mesh across the midline to the left side of the abdominal wall.The mesh was noted to lie nicely.The fascia was then further treated with closure with 0 prolene beginning at the inferior aspect of the fascia opening and coming up to the umbilicus and the sutures were tied together in the middle.The subcutaneous tissue was reapproximated with 2-0 monocryl.The skin closed with skin clips.¿ post-operative period: [4 days].On (b)(6) 2013: ¿pod [postop day] #1.¿flatus but hungry.Dressings c/d/i [clean/dry/intact].¿ on (b)(6) 2013: ¿pod #2.Pt doing well s/p rso [right salpingo-oophorectomy] & hernia repair.Tolerating diet.May be ready to go home soon.¿ on (b)(6) 2013: ¿pod #3.Nausea & vomiting last pm.Does not have nausea now but not much appetite.Blisters on buttocks.Afebrile.¿ on (b)(6) 2013: ¿pod #4.Wants to go home! ate breakfast even though vomited during [illegible].Afebrile vss [vital signs stable].+bs [bowel sounds].Incisional tenderness.Dressing good.Good progress, home.¿ on (b)(6) 2013: discharge summary: ¿she had an uneventful postoperative course with gradual resumption of bowel function, advancement to regular diet, and transition from iv pain medications to oral medications.¿ ¿on august 13, she was desirous of discharge.She tolerated her breakfast, though she had vomited the night before.Her abdomen had positive bowel sounds.The abdomen was soft and had some incisional tenderness.¿ relevant medical information: on (b)(6) 2013: ¿the vertical midline incision is healing well.There is no fluctuance of [sic] sign of infection.The staples are removed and steri-strips are placed.¿ implant #2 preoperative complaints: on (b)(6) 2015: patient seen for ¿burning pain in lower abd [abdomen].¿ ¿i do not see any masses with the us.I think she needs a ct of the abdomen and pelvis with iv and oral contrast if her renal function is adequate.¿ on (b)(6) 2015: ct abdomen/pelvis: ¿the patient is status post ventral abdominal wall hernia repair surgery.There is a recurrent periumbilical hernia containing a loop of the transverse colon.The hernia sac measures 6.8cm in size.There is no associated bowel obstruction.Extensive diverticulosis is present of the distal colon, particularly the sigmoid section.There are no inflammatory changes of acute diverticulitis, however.There is no abnormal small bowel dilatation.¿ on (b)(6) 2015: ¿30-pound weight gain, noticed new bulge in the abdomen.This is at the upper aspect of her incision, which is also close to the umbilicus.Cat scan, recurrent incarcerated incisional hernia found.This contained a loop of transverse colon.There was no bowel obstruction.In addition, a complex left ovarian cyst identified.Now for attempt at laparoscopic left oophorectomy and laparoscopic repair of the recurrent incarcerated incisional hernia with mesh.¿ implant #2 procedure: laparoscopic converted to open incarcerated recurrent incisional hernia repair with mesh, open extensive lysis of adhesions, left salpingo-oophorectomy.Implant: gore® dualmesh® plus biomaterial (12771380/1dlmcp06) 18 x 24cm.Implant #2 date: on (b)(6) 2015 [hospitalization dates unknown] findings: ¿incarcerated recurrent incisional hernia with incarcerated transverse colon, just superior to the previously placed mesh.Three other small fascial defects to the right of the upper midline.¿ description of hernia being treated: ¿numerous adhesions were noted at the midline, in the right lower quadrant, and in the right upper quadrant.The space could not be developed for placement of another trocar.I looked for several minutes for an opening and none was identified.Therefore, the procedure was converted to an open procedure.Her previous vertical midline incision was opened and dissection carried down through the skin and deep subcutaneous tissue to the fascia.The small fascial opening in the midline was identified with air in the peritoneum.This was opened.The defect was about 3cm.The loop of bowel was larger and was noted to go to the right at the midline.The hernia was reduced.A fair amount of time (about 2 hours) was used for lysis of adhesions to take the omentum and small bowel down from the anterior abdominal wall.Dissection was carried down into the left pelvis.Dr.(b)(6) then assumed care of the patient and performed the left salpingo-oophorectomy.I then assumed care of the patient again for further lysis of adhesions.The intraabdominal contents were taken down from the right upper quadrant abdominal wall.Three additional fascial defects were identified.Careful palpation revealed no other defects.The abdominal wall had been cleared of its adhesions.¿ implant size and fixation: a piece of dualmesh plus was chosen, the large piece.This was cut to size and was then secured to the fascia with through-and-through ethibond sutures.The sutures were placed 2 to 3 cm beyond the fascial defects.Each of the 3 small fascial defects just to the right of the midline were also closed before placement of the mesh with figure-of-eight 0 ethibond suture.The larger defect would be closed later above the mesh.So a running 0 ethibond suture was used to secure the mesh 2 to 3 cm beyond any fascial defect beginning in the right upper quadrant and extending inferiorly and then another suture was used beginning in the right upper quadrant and going across the midline to the left and going inferiorly.0 prolene was used to reapproximate the inferior fascial opening, which had not contained a hernia.The fascia was reapproximated using the 0 prolene suture.A piece of seprafilm was placed under this fascia appeared [sic].The mesh was secured circumferentially to the fascia taking sutures through the entire fascial and muscle layer with each bite.The mesh was noted to lie fairly nicely with minimal wrinkles.The fascial defect overlying the mesh was then closed with 0 ethibond suture.This pulled together fairly well with minimal tension.¿ post-operative period: [one week].On (b)(6) 2015: ¿underwent laparoscopy with lysis of adhesions and recurrent incarcerated incisional hernia repair with mesh and left salpingo-oophorectomy for left ovarian cyst done on (b)(6) 2015.Currently postop day 2.Yesterday doing well, minimal pain.Overnight, change in mental status, became more unresponsive.Will awake at certain times to say yes and no but unable to follow many commands.Elevated wbc 11.1, fever since 3 a.M.This morning.Pt unable to provide hx or any information.Only nurse at bedside.Contacted husband to get information.¿ ¿has toxic encephalopathy, suspected left lower lobe pneumonia, acute blood loss anemia, hyperkalemia, acute kidney injury with adequate urine output, thrombocytopenia.¿ on (b)(6) 2015: ct abdomen/pelvis: ¿pneumonia cannot be excluded in pt [patient] who exhibiting signs of infection.No complication of recent ventral hernia repair.¿ on (b)(6) 2016: discharge summary: ¿presented with recurrent incarcerated incisional hernia.This was superior to previously placed mesh.Cat scan, found to have a left ovarian cyst in an area where it was believed that she had already had salpingo-oophorectomy.Abdomen was soft with a bulge at the midline around the umbilicus that did not reduce well; in fact it did not reduce at all.There was no associated erythema, fluctuance, or sign of infection.The patient was offered attempt at laparoscopic repair with the knowledge that we might have to convert to an open procedure, so on the day of surgery, she was taken to the operating room and indeed we did have to convert to open incarcerated recurrent incisional hernia repair with mesh.Dr.(b)(6) was able to perform the left salpingo-oophorectomy.On the first postoperative day, she had minimal pain.By the second postoperative day __ [sic] had become confused.She had developed bilateral pneumonia, acute renal failure had set in along with rhabdomyolysis, and these all led to toxic metabolic encephalopathy.The hospitalists were consulted and they assisted greatly in her care.Levaquin and flagyl were started.By postoperative day #4, acute renal failure had essentially resolved along with rhabdomyolysis.Was maintained on iv antibiotics.Toxic metabolic encephalopathy had resolved.It was advised that she continue the antibiotics for a total of 7 days.By ___ [sic], she was having bowel function.She was advanced to regular diet.She had walked in the hallway, eating a regular diet, abdomen was soft, incision was fine.She still had a jp in place, which was draining 40+ ml per 24 hours.She had instructions to continue her home medications including eliquis.She was to continue levaquin 500 mg p.O.Every day for 3 more days.She was also given prescription for flagyl.Advised to use the abdominal binder.¿ relevant medical information: on (b)(6) 2016: ¿the vertical midline incision is healing well, no fluctuance or sign of infection.Some staples removed, steri-strips placed, drain removed.Some erythema inferior aspect of incision and around the jp exit site.¿ on (b)(6) 2016: ¿abdominal wound is healing well.¿ on (b)(6) 2016: ¿vertical midline incision healing well, no fluctuance, no erythema in the incision, no recurrent hernia.¿ on (b)(6) 2016: ¿vertical midline incision healing well, no fluctuance, no erythema in the incision, no recurrent hernia.¿ conclusions: it should be noted that the gore® dualmesh® plus biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.The investigation concluded that there is no relationship between the device history record findings and the event.All available information has been placed on file for use in product surveillance tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number 12771380.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

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Brand Name

GORE DUALMESH PLUS BIOMATERIAL

Type of Device

MESH, SURGICAL, POLYMERIC

Manufacturer (Section D)

W.L. GORE & ASSOCIATES

flagstaff AZ

MDR Report Key

8163985

MDR Text Key

130326311

Report Number

3003910212-2018-00123

Device Sequence Number

Product Code

FTL

UDI-Device Identifier

00733132601134

UDI-Public

00733132601134

Combination Product (y/n)

PMA/PMN Number

K063435

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

12/14/2018

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

05/31/2017

Device Model Number

1DLMCP06

Device Catalogue Number

1DLMCP06

Device Lot Number

12771380

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Hospitalization; Required Intervention;

Patient Age

79 YR

Patient Weight

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

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