MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® SOFT TISSUE PATCH; MESH, SURGICAL, POLYMERIC

Catalog Number	1310015020
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/07/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: ¿ (b)(6) 2007: (b)(6) medical center- (b)(6).(b)(6) indications: large ventral hernia, status post transplant, with secondary repair of initial incision after it fell apart.Implant procedure#1: repair of giant ventral hernia in trifurcation, left and right subcostal regions.Implant: gore-tex® soft-tissue patch [1310015020/01294039, 15cm x 20cm x 2mm thick].Implant date: (b)(6) 2007 (hospitalization unknown).¿ (b)(6) 2007: (b)(6) medical center- (b)(6) hospital.(b)(6) operative report.Assistant: (b)(6).Preoperative diagnosis: incisional ventral hernia in trifurcation region.Postoperative diagnosis: incisional ventral hernia in trifurcation region.Anesthesia: general.¿ procedure: ¿the patient was brought to the operating room.Foley catheter was inserted after general anesthesia was given.He was intubated.Preoperative antibiotics were administered.A standard bilateral subcostal incision with midline extension was opened up in the mid region and well onto the left side and partially onto the right side.We dissected the subcutaneous tissue off the fascia and then opened up the abdomen and the peritoneum, removing much of the adhesions to the sac and to the abdominal wall.We were able to undermine the fascia, which was very attenuated, and we inserted a large mesh repair 10 x 15 cm.This was done with interrupted 2-0 prolene sutures and went well underneath the extent of the hernia.We pulled this taut and tied it down.We then brought together some subcutaneous tissue over the repair with interrupted vicryls, placed a drain and then closed the skin with staples.Sponge and needle counts were correct.The patient tolerated the procedure well.¿ [handwritten]: does not say what type of mesh, or number.¿ (b)(6) 2007 [assigned]: (b)(6) medical center- (b)(6) hospital.Implant record.Implant: patch, soft tissue 2mm 10 x 15cm.Qty: 1.Mfg: wgs001.Catalog no: 1310015020.Lot number: 01294039.Site: abdomen.Type: 1 implant.Implant procedure#2/ explant procedure preoperative complaints: ¿ (b)(6) 2011: (b)(6) hospital.(b)(6) indication for the procedure: troublesome recurrent hernia defect measuring about 8 x 10 but in fact was actually larger, about 12 x 18.Implant procedure#2/ explant procedure: repair of non incarcerated recurrent ventral incisional hernia, closure with 15 x 20 gore-tex mesh.Implant: gore-tex® soft-tissue patch [nurse reviewer note: possibly gore-tex patch was used as indicated in the preoperative/postoperative diagnosis; no identification records were available for review] implant #2/explant date: (b)(6) 2011 (hospitalization unknown).¿ (b)(6) 2011: (b)(6) hospital.(b)(6).Operative report.Assistant: (b)(6).Preoperative diagnosis: end stage liver disease status post liver transplant, status post ventral hernia repair, and patch graft with trifurcation on incision with gore-tex with recurrence of hernia.Postoperative diagnosis: end stage liver disease status post liver transplant, status post ventral hernia repair, and patch graft with trifurcation on incision with gore-tex with recurrence of hernia.¿ procedure: ¿the patient was brought to the operating room after consent and was prepped and draped in standard fashion.Preoperative antibiotics were given.Venodyne stockings were checked.The old incision was opened with excision of much of the scar.We had to extend the incision far laterally until we could find good fascia and then dissected down to the fatty tissue until we found the mesh.The mesh was extracted in its entirety.It was well attached on 1 side but completely free on the other.We cleared off the fascia until we could get good grips and brought a 15 x 20 cm mesh and using 1- prolene placed sequential mattress sutures with tightening it in place.I was able to overlay some of the fascial tissue across this mesh; however, this did not contribute to the integrity of the repair.At complete, hemostasis was checked.We closed the subcutaneous tissue with 3-0 vicryl and then staples on the skin.The patient tolerated the procedure well.¿ ¿ product identification records for the alleged ¿gore-tex mesh¿ were not provided.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® soft-tissue patch instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following information was obtained from medical records.Implant procedure: repair of giant ventral hernia in trifurcation, left and right subcostal regions.Implant: gore-tex® soft-tissue patch [1310015020/01294039, 15cm x 20cm x 2mm thick].Implant date: (b)(6) 2007.Explant procedure: repair of non incarcerated recurrent ventral incisional hernia, closure with 15 x 20 gore-tex mesh.Implant #2: gore-tex® soft-tissue patch.[no allegations or adverse events for this device, therefore this product is not included as a complaint.] explant date: (b)(6) 2011.Implant #1: 3736-1.------------------------------------------------------------------ it was initially reported to gore that the patient underwent open ventral incisional hernia repair on (b)(6) 2007 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: recurrence, mesh detachment.Explant.Additional event specific information was not provided.

• Brand Name: GORE-TEX® SOFT TISSUE PATCH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: alexandrea holtsoi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17556813
• Report Number: 2017233-2023-04204
• Device Sequence Number: 20095087
• Product Code: FTL
• UDI-Device Identifier: 00733132600519
• UDI-Public: 00733132600519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K963619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2011
• Device Catalogue Number: 1310015020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 08/16/2023
• Date Device Manufactured: 04/03/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 104 KG