MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ENFORM INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Model Number	GBFR1620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Seroma (2069)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sterilization review pending.Per the instructions for use (ifu) for the gore® enform intraperitoneal biomaterial as with any mesh, use of gore® enform intraperitoneal biomaterial in the presence of contamination may result in dyspareunia, fever, infection, irritation or inflammation, pain, and wound dehiscence, and may require removal of the mesh if infection occurs.Possible adverse events with the use of any tissue deficiency prosthesis or any soft tissue reinforcement surgical procedure may include, but are not limited to additional intervention including surgery, adhesions and related harms, bowel obstruction, defect recurrence and related harms, dyspareunia, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, pain, seroma or hematoma and related harms, tissue ischemia, urinary problems, vaginal bleeding or discharge, vaginal dysfunction, and wound dehiscence.
Event or Problem Description
The information was received as a pre-publication un-titled literature draft: by (howard levinson, md, facs) regarding the use of gore® enform intraperitoneal biomaterial for ventral hernia repair.The pre-published article was submitted to the product specialist on (03/16/2021).In a total population of 12 patients, all patients had a (ventral hernia repair) with (gore® enform intraperitoneal biomaterial).The article states patient 4 was a (b)(6) male with past medical history including ibd, therapeutic anticoagulation, and previous ileostomy.He was taken to the operating room in conjunction with the colorectal surgery team for loa and ostomy reversal with bilateral component separation and onlay mesh reconstruction.He presented to the emergency department six weeks postoperatively complaining of fevers and purulent drainage from previous drain sites.Ct abdomen was obtained that demonstrated large fluid collection adjacent to the mesh concerning for abscess and active mesh infection.The patient was started on empiric iv antibiotics and taken to the operating room for abdominal washout.In the operating room the patient was found to have large pocket of purulent fluid, unincorporated mesh with intact fascia.The mesh was removed and negative pressure wound therapy was placed.The patient continued to recover well with antibiotic regimen and local wound care.
Additional Manufacturer Narrative
Sterilization review: sterilization was reviewed, including the associated sterilization preparation mps, lal test results, bi sterility test report, and sterilization certificate of processing and process verification.Sterilization was processed in accordance with standard operating procedures and met all processing requirements.
Additional Manufacturer Narrative
Section h6 remove codes: 4315 cause not established, 4625 additional surgery, and remove 2993 adverse event without identified device or use problem.
Additional Manufacturer Narrative
It should be noted that the gore® enform® 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.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.Individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without enform.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, migration, 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.

• Brand Name: GORE® ENFORM INTRAPERITONEAL BIOMATERIAL
• Common Device Name: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11667360
• Report Number: 3003910212-2021-01200
• Device Sequence Number: 2980443
• Product Code: OXF
• UDI-Device Identifier: 00733132644704
• UDI-Public: 00733132644704
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2022

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: 10/02/2022
• Device Model Number: GBFR1620
• Device Catalogue Number: GBFR1620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 03/16/2021; 03/16/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/17/2021; 05/27/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 57 YR
• Patient Sex: Male