| Catalog Number 1DLMC03 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Not Applicable (3189)
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| Event Date 09/21/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.(b)(6).It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent laparoscopic umbilical hernia repair on (b)(6) 2007, whereby an alleged ¿gore-tex¿ device was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure was performed whereby explant of the gore device was performed.It was reported the patient alleges the following injuries: additional surgeries, abdominal pain, mesh removal, extensive adhesions.Additional event specific information was not provided.
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Manufacturer Narrative
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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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Added common device name.Added lot #, catalog #, expiration date, di #.Added pma/510k #.Added device manufacture date.Updated method/results codes.Conclusion code remains unchanged.
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Manufacturer Narrative
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Please note the initial medwatch indicates an incorrect date gore aware of 11/12/2018.The date gore aware of information for the initial report is 11/10/2018.B7: added medical history.H6: codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.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 8/21/2007 were not provided.Operative records dated 8/21/2007 state the patient underwent laparoscopic umbilical hernia repair with gore-tex mesh.The ¿patient is a 33 year old gentleman with a symptomatic umbilical hernia for over a year with events of no bowel contents however probably preperitoneal fat which is concentrated.¿ the operative records dated 8/21/2007 state: ¿three left lateral ports were placed one at palmar's point and 2 in the left lateral positions.The first port was placed using a versa-step needle, insufflation up to 18 mm.After adequate insufflation a 5 mm port was inserted at this point.An 11 mm port was placed in the left lateral and another 5 mm was also placed.The pressure was then reduced to 15 mm.On entering the abdominal cavity with a 10 mm 30 degree camera there was noticed some omentum stuck in the umbilical hernia which was reduced without difficulty.There was also noted to be preperitoneal fat with hematoma content; with a harmonic scalpel this was excised exposing the hernia defect.There were no other defects identified in the abdominal wall.¿ records dated 8/21/2007 continue: ¿the periumbilical hematoma was extracted using endocatch bag and sent to pathology after which a gore-tex mesh was measured with 3 cm borders around the hernia defect and cut to the appropriate measurements.Four gore-tex stitches were then placed in the mesh prior to placement in the abdominal cavity.The mesh was then placed in the abdominal cavity.The inlet closure device was used to bring these stitches through the abdominal wall.These were brought out through separate incisions and tied appropriately.The protek 5 mm was then used to secure the gore-tex mesh.This mesh appeared to be in good position.The ports were then removed under direct visualization and closed with 4-0 biosyn.Dermabond was applied to all the incisions.¿ records confirm a gore-tex mesh was implanted, however, product id records were not provided.Operative records dated 10/7/2008 state the patient underwent diagnostic laparoscopy with laparoscopic lysis of adhesions for possible recurrent ventral hernia.The ¿patient is a 38-year-old gentleman who presents with a history of a laparoscopic repair of an umbilical hernia approximately a year ago.The patient developed additional pain, for which he had a ct scan of the abdomen.The ct scan suggested that there was a possible recurrence of the hernia.¿ the records dated 10/7/2008 state: ¿a right upper quadrant veress needle incision was made and the abdomen accessed on the first attempt.The abdomen was insufflated.Three 5 mm ports were placed.Inspection of the mesh repair revealed that there was a goretex dualmesh sitting in position.After dissecting away the adhesions and lysing the adhesions, it became evident that there was some contraction of the mesh, but there was no defect evident either peripherally around the mesh or centrally.¿ the operative records dated 10/7/2008 continue: ¿additionally, there was no area where the mesh had come loose or torn away from the surface of the abdominal wall.There was certainly no evidence for recurrence.There were, in fact, 2 loops of intestine that were stuck to the undersurface of the mesh.These were dissected away from the mesh carefully and allowed to return to their normal position in the abdomen.There were some adhesions between these loops that were then lysed so that there was no area around which bowel could become looped.¿ the 10/7/2008 records state: ¿complete inspection of the mesh revealed that the tacks appeared to be within good position.There was no evidence for the mesh pulling away from the abdominal wall.Given this, it was felt that there was no indication for re-repair as there was no hernia defect palpable or evident.The area was thoroughly inspected for hemostasis, which was secured.The wounds were then closed in standard fashion.Steri- strips were applied.¿ only records provided between 10/7/2008 and 4/22/2016 are records dated 9/3/2014 which include a medical clearance request, pre admission records and consent for surgery by dr.Paresh shah for incisional hernia repair, explant of old mesh, layered reconstruction.No additional records dated 9/3/2014 were provided.Operative records dated 4/22/2016 states the patient underwent laparoscopic repair of left inguinal hernia with mesh and laparoscopic repair of incarcerated ventral hernia with mesh.The ¿patient is a 41-year-old gentleman who presents with a symptomatic incarcerated epigastric ventral hernia.In addition, he was found to have a left inguinal hernia.¿ the operative records dated 4/22/2016 states: ¿a skin incision was made and the preperitoneal space accessed via a right medial retromuscular approach.A balloon dissector was deployed to create the preperitoneal space.Two 5 mm ports were then placed in the lower midline after placing the balloon trocar at the periumbilical port site.The findings were an indirect inguinal hernia containing largely fat.The hernia was dissected away from the cord structures and the dissection carried all the way down to the psoas muscle.¿ the 4/22/2016 records continue: ¿the peritoneum was extremely thin and the decision was made to use a parietex composite mesh to prevent any adhesions that could develop to the mesh.A 10 x 15 cm piece of parietex composite mesh was obtained.It was cut to 5 x 4.5 inches.The mesh was rolled and then placed into the preperitoneal space.It was tacked once at the symphysis pubis with a pro tack tacker.It was then tacked across the medial and superior borders with the absorbatack tacker.The mesh was seen to be sitting in excellent position.¿ the records dated 4/22/2016 state: ¿at this point, the fascial incision at the medial aspect of the right rectus sheath was closed with a running o vicryl suture.Attention then turned to gaining access to the abdominal cavity to repair the incarcerated epigastric hernia.A veress needle approach was utilized using a left upper quadrant incision.The abdomen was accessed on the first attempt and then insufflated.A 5 mm port was placed in the left upper quadrant and then three additional 5 mm ports placed at the corners of the abdomen.There were some adhesions to the area of the hernia.There was a portion of obviously incarcerated fat.¿ records dated 4/22/2016 continue: ¿the adhesions were taken down with the ligasure device.The incarcerated fat was reduced and returned to the abdominal cavity.The defect itself was really quite small, measuring approximately 1 x 1 cm.The decision was made to repair it with a 9 cm parietex composite mesh.Of note, this defect was approximately 3 to 4 cm above the level of the top of the previously placed gore-tex mesh for his umbilical hernia years ago.That repair by the way looked to be completely intact.¿ the 4/22/2016 records state: ¿the dissection proceeded to strip the fat from the medial aspect of the abdominal wall with the ligasure.This cleaned the surface for the parietex composite mesh.This was then obtained and moistened.Two 2-0 vicryl sutures were placed at the north and south positions.The mesh was then brought into the abdominal cavity through the right lower quadrant port site.This was of note still a 5 mm port site.The two sutures were then retrieved with the endo dose device and the mesh brought up into place, the mesh was sitting in an excellent position.¿ the records dated 4/22/2016 continue: ¿the absorbatack tacker was then used to tack the mesh circumferentially at the edges and then several additional tacks were placed across the middle portions of the mesh.The mesh was sitting in excellent position.The entire tacking portion had been done with the intraabdominal pressure at 8 mmhg.The ports were then withdrawn under direct vision without evidence for bleeding.The skin incisions were then closed with 4-0 biosyn suture.Steri-strips and sterile dressings were applied.¿ it is unclear from the records if the gore device and previously implanted parietex device overlapped.Medical records dated 8/10/2017 state: ¿patient here with chronic abdominal pain for years since hernia repairs x2.Has had a lap umbilical and lap ventral hernia repair with mesh.Had an sbo postoperatively and had lap lysis of adhesions.Since these surgeries he has had chronic abdominal pain that has been debilitating to him.Is unable to work.Has seen a number of surgeons, including his original hernia surgeon.He has been to pain management and all have told him he may need his mesh explanted but have referred him for other options.Records detailing the small bowel obstruction and additional lysis of adhesions were not provided.The medical records dated 8/10/2017 continue: ¿abdomen is obese, soft, diffusely tender to palpation in the mid abdomen but without any peritoneal signs.Multiple well healed incisions.Patient with chronic abdominal pain [status post] two ventral hernia repairs with mesh.He is asking for explantation of the mesh.We discussed that removing the mesh would be a big operation with significant risks that would leave him with an even larger hernia that we would have limited options in fixing if we can¿t use mesh.We also discussed that there would be no guarantees that he would even feel better after the surgery.I recommended he see his original surgeon for further management.¿ operative records dated 9/21/2017 states the patient underwent removal of implanted intraabdominal mesh and primary repair of incisional hernia.The patient ¿is a 43-year-old male, morbidly obese.With past medical history significant for multiple laparoscopic ventral hernias that was referred for a second opinion for removal of his intraabdominal mesh after the patient has been experiencing severe abdominal pain and had tried every treatment, anti-inflammatory, narcotics, pain management with no effect.His ct showed a small midline supraumbilical hernia and the mesh in good position.The patient was counseled and he strongly requested the mesh removed.¿ the records dated 9/21/2017 continue: ¿using a 15 blade, a supraumbilical and infraumbilical incision was made and was carried down through the subcutaneous tissue.Eventually, the peritoneal cavity was entered, the mesh was identified and was shaved off the peritoneum with the tacks using bovie cautery.The mesh was removed in its entirety.There were some omental adhesions at the anterior abdominal wall, which was lysed.The rest of the peritoneum was examined and no further evidence of tacks were found.¿ records dated 9/21/2017 continue: ¿the fascia edges were cleared approximately 1 inch radius, and the incision was closed with #1 looped pds in running fashion.The umbilicus was reimplanted using 2-0 vicryl.The subcutaneous approximated with 3-0 vicryl and the skin was closed with staples, 4x4 and large tegaderm.¿ there was no mention of infection in the records.It is unclear from the records if both the gore device and the parietex mesh were explanted during the procedure.A pathology report for the specimens collected during the 9/21/2017 procedure 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Conclusion code remains unchanged.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) 2017: office notes.Cc: f/u hernia.Hpi: hx of abdominal pain s/p ventral hernia repair w/ mesh and sbo s/p lap loa was evaluated for removal of mesh.Pmh: small bowel obstruction.Psh: 2016; inguinal hernia repair, incarcerated epigastric ventral hernia.On (b)(6) 2008; ventral hernia repair.On (b)(6) 2007; umbilical hernia repair w/ mesh.Exam: abdomen soft tender to palpation w/ some guarding and no rebound tenderness.Impression/plan: discussed w/ pt needs to produce a letter clarifying surgery may not resolve pain, surgery entails many risks including, bowel injury, bowel resection and possible ostomy creation, abdominal wound infection, may leave him w/ new hernia, may require further surgeries.Commits for post-operative f/u as recommended.And clearly release me from any possible litigation r/t any of the above.Possible scenarios.Only after that i will schedule for removal of mesh and metal tacks, repair of the abdominal wall w/out a mesh.Will not address inguinal hernia.Return in 2 weeks.On (b)(6) 2017: progress notes.S/p excision of abdominal wall mesh and primary repair of incisional hernia doing well postoperatively w/ good pain control.Abdomen w/ abd binder, midline incision w/ dressing mildly soaked w/ blood.Appropriately tender and distended.No guarding, no rebound.Impression/plan: morbidly obese male w/ hx ventral/umbilical hernia repairs, now s/p excision of mesh and primary incisional hernia repair.Tentative discharge tomorrow.On (b)(6) 2017: attestation note.Doing well, tolerating diet.Abdomen soft, nontender.Impression/plan: advance diet, oob [out of bed] and ambulate.D/c home once ready.F/u in office in 1-2 weeks.On (b)(6) 2017: emergency department.Hpi: c/o abdominal pain-lower.Hx umbilical and ventral hernia s/p surgery w/ mesh placement and recent removal of mesh on (b)(6) 2017.Abdominal pain, pus draining around surgical scar, started 2 days ago.Chills and nausea/vomiting for 2 days.Yesterday noticed shirt soaked w/ yellowish foul-smelling pus.Went to (b)(6) liked.Ct abd/pelvis done, showed large midline anterior abdominal wall fluid collection, possibly superinfected.Transferred to msbi ed.Social hx: nonsmoker, no alcohol or drug use.Psh: ventral hernia repair w/ mesh 2008.Umbilical hernia repair 2007.Ros: unremarkable except positive for nausea, vomiting, and abdominal pain.Exam: unremarkable except soft, distended, large midline surgical scar with 2 cm and 1 cm open ulceration w/ yellowish pus.Tender to palpation wound surgical site.Plan: discharge, send wound culture, f/u w/ dr.(b)(6) 2-3 weeks.On (b)(6) 2017: discharge information: likely have a seroma based on ct scan and lab work.Do not need antibiotics.F/u w/ dr.(b)(6) w/ in 1 week.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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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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) 07: new york presbyterian.Implant record.Implants used: w.L.Gore.Implant description: gortex dual mesh 10 cm x 15 cm.Cat./ref number: 1dlmc03.Lot number: 04682391.Serial number: (b)(4).Site: umbilical.Expiration date: 10/23/2011.The records confirm a gore® dualmesh® biomaterial (1dlmc03/04682391) was implanted during the procedure.(b)(6) 07: new york presbyterian hospital.Neda yagan, md.Radiology-ct abdomen/pelvis.Impression: findings suspicious for epiploic appendigitis of the ascending colon vs.Likely, small omental infarct.Cholelithiasis without ct evidence of acute cholecystitis.(b)(6) 07: [possible date discrepancy; should be specimen collected (b)(6) 07.New york presbyterian hospital.Department of pathology.Thomas j.Fahey iii, md.Surgical pathology report.S07-26509.Clinical information: laparoscopic umbilical repair.Specimen submitted: a.Umbilical hernia contents.Gross description: a.Received fresh, the specimen is labeled ¿umbilical hernia contents¿ and consists of one pieces of glistening, fibromembranous tissue measuring 6.0 x 5.0 x 2.0 cm with attached fat.Representative sections submitted.Summary of sections: a1.Diagnosis: umbilical hernia contents (excision): fibroadipose tissue with mild chronic inflammation and hemorrhage.(b)(6) 07: new york presbyterian.Thomas fahey, md.Discharge summary.Discharge diagnosis: umbilical hernia, hypertension, regional sympathetic dystrophy.Hpi: presented to ed with abdominal pain which had been worsening over 24 hrs.Abdomen diffusely tender and distended.Ct scan showed suspicious epiploic appendigitis of ascending colon vs likely small omental infarct revealed umbilical hernia.Patient course: laparoscopic repair of umbilical hernia with mesh.Physical activity: no heavy lifting or strenuous activity for 4-6 wks.Keep binder on for 2 wks.A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: codes 4118/3221 - product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records dated (b)(6)2008 state: ¿34 yo aa m who presents to ed with abdominal pain that is ongoing but is getting worse and he ¿can¿t take it anymore.¿ pt is s/p repair of umbilical hernia with mesh (b)(6) by dr.(b)(6).He has had pain and intermittent nausea/vomiting.Pain is 10/10 and located in periumbilical area.¿ ¿recent ct scan (9/19): mesh seen on anterior abdominal wall; 3.0x2.2cm umbilical hernia containing mesenteric fat overlying the mesh.Few tiny calcifications in gb, most likely gallstones, seen.Otherwise normal.¿ abdominal x-ray results dated (b)(6)2008 state: ¿clinical statement: abdominal pain.¿ ¿findings: multiple surgical coils are noted over the lower midabdomen compatible with interval umbilical hernia repair.The bowel gas pattern is nonobstructive.There is no free intraperitoneal air.No pathologic intraabdominal calcifications are identified.¿ ¿no evidence of bowel obstruction or pneumoperitoneum.¿ the records indicate the patient was admitted ¿d/t umbilical hernia likely incarcerated.¿ abdominal x-ray results dated (b)(6)2008 state: ¿clinical statement: abdominal distention, suspect obstruction.¿ ¿findings: there has been no significant interval change.There are no dilated loops of large or small bowel.Contrast is identified in the colon.Multiple surgical clips are identified over the lower abdomen consistent with the patient¿s recent umbilical hernia repair.¿ ¿no evidence of obstruction.¿ records between (b)(6)2008 and (b)(6)2012 were not provided.Records dated (b)(6)2012 state: ¿38m [past medical history] htn, umbilical hernia s/p lap repair with mesh in ¿07 c/b abdominal pain for which he underwent essentially negative diagnostic laparoscopy in ¿08 p/w 2 weeks of abdominal pain.Describes pain as diffuse but worse in epigastrium and ruq.Worse with meals but has been able to tolerate po.No n/v, but reports that abdomen gets distended after meals.¿ ¿clinical findings not c/w obstruction, though pt is distended.¿ additional records dated (b)(6) 2012 state: ¿¿presenting with recurrent abd distention and pain.He has had intermittent abd pain since the time of the hernia repair, epigastric and periumbilical, sharp, associated with bloating and abd distension, provoked by increased po intake, esp fluids.¿ abdominal x-ray results dated (b)(6)2012 state: ¿clinical statement: abdominal pain.¿ ¿findings: stool and gas are seen throughout the nondilated colon.Paucity of small bowel gas limits evaluation for early or partial small bowel obstruction.Evaluation of free intraperitoneal air is limited on supine evaluation.¿ ct results dated (b)(6)2012 state: ¿clinical statement: abdominal pain and distention.History of multiple prior abdominal surgeries for umbilical hernias.¿ ¿gastrointestinal tract: no evidence of bowel obstruction.Normal appendix.¿ ¿abdominal wall: status post mesh repair of a ventral abdominal hernia.No hernia visualized.¿ the only records provided between (b)(6)2012 and (b)(6)2015 are records dated(b)(6)2014 , which include a medical clearance request, pre admission records and consent for surgery by dr.(b)(6) for incisional hernia repair, explant of old mesh, layered reconstruction.No additional records dated(b)(6)2014 were provided.Records dated (b)(6)2015 state: ¿41 y/o m, pmhx of r inguinal hernia repaired by dr.(b)(6) in 2007, sbo and loa with redo mesh in 2008, comes into the ed for possible right abdominal incisional hernia that started in (b)(6)2015 and has increased in pain over the last 2 weeks.States that the abdominal pain starts in the mid-abdomen and radiated down into the testicles.¿ ct results dated (b)(6)2015 state: ¿clinical statement: abdominal pain.Evaluate for right-sided hernia.¿ ¿abdominal wall: stable small fat-containing left inguinal hernia.Status post ventral hernia repair.¿ ¿impression: no right-sided abdominal wall hernia.Status post ventral hernia repair, unchanged since (b)(6)2012.Stable small fat-containing left inguinal hernia.¿ consultation records dated (b)(6)2015 state: ¿he notes that the pain continues, predominantly on the right side, and states he noted a ¿swelling¿ on the right side of his abdomen in june.¿ exam notes state: ¿soft, obese, mildly ttp [sic] right side abdomen, no ventral hernia noted on exam, no reboud or guarding; well healed surgical incisions; no inguinal bulges appreciated on exam, non-tender.¿ ¿given that this has been ongoing process for several months, with no acute change and that all labs wnl with no acute ct findings; no surgical intervention required at this time.¿ records dated(b)(6)2016 state the patient presented to the emergency department with complaints of ¿¿1.5 weeks of intermittent umbilical pain, in the setting of known hernia.Pt reports for the past 1.5 weeks, he experienced worsening umbilical pain, associated with growing hernial mass, not alleviated with tylenol and exacerbated with movement and bm.¿ consult records dated (b)(6)2016 state: ¿41m w/ htn, obesity, and umbilical hernia s/p lap umbilical hernia repair w/ mesh (dr.(b)(6) (b)(6)2007) c/b recurrent pain s/p diagnostic laparoscopy w/ loa (dr.(b)(6), (b)(6)2008 ¿ no recurrence noted at that time), now w/ increasing luq pain x2 weeks.Pt states he has felt a bulge in his luq for the last several weeks.States that the bulge grows with movement or bending but that he is always able to reduce it.Over the last 2 weeks or so, the bulge (when present) has become increasingly painful.¿ ct results dated (b)(6)2016 state: ¿clinical statement: right lower quadrant pain and left groin pain.¿ ¿findings: status post mesh repair of a small fat-containing umbilical hernia.The mesh is better visualized on ct but overall appearance is grossly stable.Only fat is seen superficial to the mesh.No bowel involvement.No fluid collection or signs of inflammation.There is no evidence of a right inguinal hernia.There is slightly asymmetric fat along the spermatic cord on the left without definite abdominal wall defect, suggestive of a small spermatic cord lipoma.The possibility of a small fat-containing indirect inguinal hernia cannot be entirely excluded.This appearance is unchanged over serial exams for several years.¿ ¿essentially stable appearance of umbilical hernia mesh repair, with stable amount of fat superficial to the mesh.No bowel involvement or fluid collection.¿ mri results dated (b)(6)2016 state: ¿clinical statement: peri-umbilical pain and palpable hernia.History of ventral hernia repair, concern for strangulated/incarcerated ventral hernia.Patient reported to the emergency department after obtaining outpatient mris due to increasing abdominal pain.¿ ¿abdominal wall: prior ventral abdominal wall mesh repair, better seen on the prior ct.No evidence of bowel extending into the repaired hernia region.Prominent umbilical fat reflect anatomic variation.No evidence of recurrent hernia.More superiorly, there is a 1.2 cm fat-containing supraumbilical hernia¿left inguinal hernia is better visualized on the mri pelvis from today.¿ impression states: ¿1.Moderate hepatic steatosis.2.Repaired ventral hernia at the level of the umbilicus.Supraumbilical small fat-containing hernia.3.Left inguinal fat-containing hernia.4.No bowel obstruction.No bowel containing hernias.¿ the records dated (b)(6)2016 continue: ¿the absorbatack tacker was then used to tack the mesh circumferentially at the edges and then several additional tacks were placed across the middle portions of the mesh.The mesh was sitting in excellent position.The entire tacking portion had been done with the intraabdominal pressure at 8 mmhg.The ports were then withdrawn under direct vision without evidence for bleeding.The skin incisions were then closed with 4-0 biosyn suture.Steri-strips and sterile dressings were applied.¿ it is unclear from the records if the previously implanted gore device and parietex device overlapped.Ct scan results dated (b)(6)2017 state: ¿clinical statement: intermittent abdominal pain and dyspepsia status post ventral hernia repair.¿ ¿abdominal wall: no hernia.Postsurgical changes of prior ventral hernia repair, with intact mesh.Focal area of fat necrosis in the subcutaneous fat superior to the umbilicus¿ small fat-containing umbilical hernia, unchanged.Tiny left fat-containing inguinal hernia.¿ records dated (b)(6)2017 state the patient was seen for pain at a dermatology clinic.¿the patient is a 43 y.O male w/ history of umbilical hernia repair and other hernia repairs since 2007 who presents for evaluation of a possible patch testing due to recurrent abdominal pain.Pain in abdomen began immediately after 2007 and has lasted since then.Pt has had multiple ed visits and has been followed by neuropsych.Pt reports pain increasing in recent months and causing debilitating pain preventing him from working¿¿ ¿per dr.(b)(6) note on 8/1/17, testing for marlex, polyester, ptfe, and standard synthetic compounds was requested.Per patient, meshes used were gortex [sic].Last ct scan in (b)(6)2017 showed fatty liver but no source of pain.Pt has had no skin rashes.He has been seen by neuro psych for reflex sympathetic dystrophy and has reported adjustment disorder.He has had chronic pain in shoulders and hands in the past s/p multiple surgeries.Pt was a former football player.¿ assessment from the (b)(6)2017 visit states: ¿chronic abdominal pain for > 10 years: patient feels that it is associated with mesh.Pt does have a diagnosis of reflex sympathetic dystrophy and is not currently followed by pain management.While it is possible that the cause of the pain may be due to a contact allergy to a mesh product, this is extremely rare and there is no evidence of visceral inflammation around the mesh in the ct obtained in (b)(6)2017 when patient had pain.It can be helpful to evaluate possible replacement products for potential allergy prior to placement given the patient¿s current concerns.¿ the records indicate patch testing was recommended prior to the (b)(6)2017 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 although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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H6: updated patient codes.H6: updated device code.H6: updated conclusion codes.Previous patient codes (1695, 1994) 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 following information was determined from the medical records.Medical records: the known medical records span august 21, 2007 through october 9, 2017, and not all records received in this time span are relevant to gore® dualmesh® biomaterial.Records from october 9, 2008 through december 28, 2012; from december 31, 2012 through august 1, 2015 were not provided.Patient information: medical history: hypertension, morbid obesity, 259 lbs., bmi 39.6, sleep apnea.Prior surgical procedures: on (b)(6) 2007: left shoulder arthroscopy, on (b)(6) 2007: left knee arthroscopy, on (b)(6) 2007: right shoulder arthroscopy, on (b)(6) 2007: right knee arthroscopy.Implant preoperative complaints: on (b)(6) 07: ¿symptomatic umbilical hernia for over a year with events of no bowel contents however probably preperitoneal fat which is concentrated.¿ implant procedure: laparoscopic umbilical hernia repair with mesh.Implant: gore® dualmesh® biomaterial (04682391 /1 dlmc03) 10 cm x 15 cm, oval.Implant date: on (b)(6) 2007 [hospitalization dates unknown].Description of hernia being treated: ¿on entering the abdominal cavity with a 10 mm 30 degree camera there was noticed some omentum stuck in the umbilical hernia which was reduced without difficulty.There was also noted to be preperitoneal fat with hematoma content; with a harmonic scalpel this was excised exposing the hernia defect.There were no other defects identified in the abdominal wall.The periumbilical hematoma was extracted using endocatch bag and sent to pathology.¿ implant size and fixation: ¿a gore-tex mesh was measured with 3 cm borders around the hernia defect and cut to the appropriate measurements.Four gore-tex stitches were then placed in the mesh prior to placement in the abdominal cavity.The mesh was then placed in the abdominal cavity.The inlet closure device was used to bring these stitches through the abdominal wall.These were brought out through separate incisions and tied appropriately.The protek 5 mm was then used to secure the gore-tex mesh.This mesh appeared to be in good position.¿ post-operative period: [one week].On (b)(6) 2007: ct abdomen / pelvis: ¿findings suspicious for epiploic appendigitis of the ascending colon vs.Likely, small omental infarct.Cholelithiasis without ct evidence of acute cholecystitis.¿ on (b)(6) 2007: ¿presented to ed with abdominal pain which had been worsening over 24 hrs.Abdomen diffusely tender and distended.Ct scan showed suspicious epiploic appendigitis of ascending colon vs likely small omental infarct revealed umbilical hernia.Patient course: laparoscopic repair of umbilical hernia with mesh.Physical activity: no heavy lifting or strenuous activity for 4-6 wks.Keep binder on for 2 wks.¿ relevant medical information: on (b)(6) 2008: emergency room: ¿pt is s/p repair of umbilical hernia with mesh on (b)(6) 2007 by dr.(b)(6).He has had pain and intermittent nausea / vomiting.Pain is 10/10 and located in periumbilical area.¿ ¿recent ct scan (on (b)(6): mesh seen on anterior abdominal wall; 3.0x2.2cm umbilical hernia containing mesenteric fat overlying the mesh.Few tiny calcifications in gb, most likely gallstones, seen.Otherwise normal.¿ on (b)(6) 2008: laparoscopic lysis of adhesions for possible recurrent ventral hernia ¿three 5 mm ports were placed.Inspection of the mesh repair revealed that there was a goretex dualmesh sitting in position.After dissecting away the adhesions and lysing the adhesions, it became evident that there was some contraction of the mesh , but there was no defect evident either peripherally around the mesh or centrally.Additionally, there was no area where the mesh had come loose or torn away from the surface of the abdominal wall.There was certainly no evidence for recurrence.There were, in fact, 2 loops of intestine that were stuck to the undersurface of the mesh.These were dissected away from the mesh carefully and allowed to return to their normal position in the abdomen.There were some adhesions between these loops that were then lysed so that there was no area around which bowel could become looped.Complete inspection of the mesh revealed that the tacks appeared to be within good position.There was no evidence for the mesh pulling away from the abdominal wall.Given this, it was felt that there was no indication for re-repair as there was no hernia defect palpable or evident.¿ on (b)(6) 2008: x-ray abdomen: ¿no evidence of obstruction¿ on (b)(6) 2012: ¿presenting with recurrent abd [abdominal] distention and pain.He has had intermittent abd pain since the time of the hernia repair, epigastric and periumbilical, sharp, associated with bloating and abd distension, provoked by increased po intake, especially fluids.¿ on (b)(6) 2012: ct abdomen: ¿no evidence of bowel obstruction.Normal appendix.¿ ¿status post mesh repair of a ventral abdominal hernia.No hernia visualized.¿ on (b)(6) 2015: ct abdomen / pelvis: ¿no right-sided abdominal wall hernia.Status post ventral hernia repair, unchanged since on (b)(6) 2012.Stable small fat-containing left inguinal hernia.¿ on (b)(6) 2015: ¿soft, obese, mildly ttp [tender to palpation] right side abdomen, no ventral hernia noted on exam, no rebound or guarding; well healed surgical incisions; no inguinal bulges appreciated on exam, non-tender.¿ ¿given that this has been ongoing process for several months, with no acute change and that all labs wnl [within normal limits] with no acute ct findings, no surgical intervention required at this time.¿ on (b)(6) 2016: ct abdomen: ¿status post mesh repair of a small fat-containing umbilical hernia.The mesh is better visualized on ct but overall appearance is grossly stable.Only fat is seen superficial to the mesh.No bowel involvement.No fluid collection or signs of inflammation.There is no evidence of a right inguinal hernia.There is slightly asymmetric fat along the spermatic cord on the left without definite abdominal wall defect, suggestive of a small spermatic cord lipoma.The possibility of a small fat-containing indirect inguinal hernia cannot be entirely excluded.This appearance is unchanged over serial exams for several years.¿ on (b)(6) 2016: mri abdomen / pelvis: ¿1.Moderate hepatic steatosis.2.Repaired ventral hernia at the level of the umbilicus.Supraumbilical small fat-containing hernia.3.Left inguinal fat-containing hernia.4.No bowel obstruction.No bowel containing hernias.¿ on (b)(6) 2016: laparoscopic repair of left inguinal hernia with mesh and laparoscopic repair of incarcerated ventral hernia with mesh. ¿the findings were an indirect inguinal hernia containing largely fat.The hernia was dissected away from the cord structures and the dissection carried all the way down to the psoas muscle.The peritoneum was extremely thin and the decision was made to use a parietex composite mesh to prevent any adhesions that could develop to the mesh.A 10 x 15 cm piece of parietex composite mesh was obtained.It was cut to 5 x 4.5 inches.The mesh was rolled and then placed into the preperitoneal space.It was tacked once at the symphysis pubis with a pro tack tacker.It was then tacked across the medial and superior borders with the absorbatack tacker.The mesh was seen to be sitting in excellent position.¿ ¿the adhesions were taken down with the ligasure device.The incarcerated fat was reduced and returned to the abdominal cavity.The defect itself was really quite small, measuring approximately 1 x 1 cm.The decision was made to repair it with a 9 cm parietex composite mesh.Of note, this defect was approximately 3 to 4 cm above the level of the top of the previously placed gore-tex mesh for his umbilical hernia years ago.That repair by the way looked to be completely intact.¿ records confirm a non-gore device was implanted during the procedure on (b)(6) 2016.On (b)(6) 2017: ct abdomen / pelvis: ¿no hernia.Postsurgical changes of prior ventral hernia repair, with intact mesh.Focal area of fat necrosis in the subcutaneous fat superior to the umbilicus.Small fat-containing umbilical hernia, unchanged.Tiny left fat-containing inguinal hernia.¿ on (b)(6) 2017: ¿has had a lap umbilical and lap ventral hernia repair with mesh.Had an sbo postoperatively and had lap lysis of adhesions.Since these surgeries he has had chronic abdominal pain that has been debilitating to him.Is unable to work.Has seen a number of surgeons, including his original hernia surgeon.He has been to pain management and all have told him he may need his mesh explanted but have referred him for other options.Records detailing the small bowel obstruction and additional lysis of adhesions were not provided.Abdomen is obese, soft, diffusely tender to palpation in the mid abdomen but without any peritoneal signs.Multiple well healed incisions.Patient with chronic abdominal pain [status post] two ventral hernia repairs with mesh.He is asking for explantation of the mesh.We discussed that removing the mesh would be a big operation with significant risks that would leave him with an even larger hernia that we would have limited options in fixing if we can't use mesh.We also discussed that there would be no guarantees that he would even feel better after the surgery.I recommended he see his original surgeon for further management.¿ on (b)(6) 2017: ¿pt does have a diagnosis of reflex sympathetic dystrophy and is not currently followed by pain management.While it is possible that the cause of the pain may be due to a contact allergy to a mesh product, this is extremely rare and there is no evidence of visceral inflammation around the mesh in the ct obtained on (b)(6) 2017 when patient had pain.¿ on (b)(6) 2017: ¿discussed w / pt [patient] needs to produce a letter clarifying surgery may not resolve pain, surgery entails many risks including, bowel injury, bowel resection and possible ostomy creation, abdominal wound infection, may leave him w / new hernia, may require further surgeries.Commits for post-operative f/u [follow-up] as recommended.And clearly release me from any possible litigation r/t [related to] any of the above possible scenarios.Only after that i will schedule for removal of mesh and metal tacks, repair of the abdominal wall w/out a mesh.Will not address inguinal hernia.¿ explant preoperative complaints: on (b)(6) 2017: ¿referred for a second opinion for removal of his intraabdominal mesh after the patient has been experiencing severe abdominal pain and had tried every treatment, anti-inflammatory, narcotics, pain management with no effect.His ct showed a small midline supraumbilical hernia and the mesh in good position.The patient was counseled and he strongly requested the mesh removed.¿ explant procedure: removal of implanted intraabdominal mesh and primary repair of incisional hernia.Explant date: on (b)(6) 2017 [hospitalization dates unknown].¿eventually, the peritoneal cavity was entered, the mesh was identified and was shaved off the peritoneum with the tacks using bovie cautery.The mesh was removed in its entirety.There were some omental adhesions at the anterior abdominal wall, which was lysed.The rest of the peritoneum was examined and no further evidence of tacks were found.¿ it is unclear from the records if both the gore device and the parietex mesh were explanted during the procedure.Relevant medical information: on (b)(6) 2017: emergency department: ¿abdominal pain, pus draining around surgical scar, started 2 days ago.Chills and nausea/vomiting for 2 days.Yesterday noticed shirt soaked w/ yellowish foul-smelling pus.Went to northshore liked.Ct abd / pelvis done, showed large midline anterior abdominal wall fluid collection, possibly superinfected.¿ on (b)(6) 2017: discharge information: ¿likely have a seroma based on ct scan and lab work.Do not need antibiotics.F/u w/ dr.(b)(6) w/ in 1 week.¿ conclusion: it should be noted that the gore® dualmesh® biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The device was not able to be returned 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.All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Search Alerts/Recalls
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