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

Model Number	GKFC12
Medical Device Problem Codes	Use of Device Problem (1670); Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device utilized in procedure: item #gkfv1520/lot #21139574/udi # (b)(4)/mfr.Report #3003910212-2020-00098.According to the instructions for use (ifu) for gore® synecor intraperitoneal biomaterial, as with any surgical procedure, there are always risks of complications for surgical repair of hernias, 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, hernia recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, lung function, impairment, pain, paresthesia, perforation, revision/re-surgery, seroma or hematoma and related harms, wound complications and wound dehiscence.
Event or Problem Description
It was reported to gore by the field sales associate that approximately 5 weeks ago the surgeon performed a lap incisional hernia repair, while also performing concomitant ileostomy and colostomy take down and periumbilical hernia.The surgeon reported about a week ago (4 weeks post op) the patient presented with a mesh infection and necrotizing fasciitis.The surgeon removed the two pieces of gore® synecor intraperitoneal biomaterial.The surgeon reported there was no adhesion issues, but felt the bioa layer remained on the peritoneum.It was reported the surgeon went back in the patient yesterday and said it appeared that the bioa had now adhered to the bowel and fistulas were present.Reportedly, the surgeon was not certain the fistulas were due to the bioa and he was not certain the infection was due to the gore® synecor intraperitoneal biomaterial.It was reported the surgeon was looking for guidance and trying to piece the information together.
Additional Manufacturer Narrative
H6.Results code - 213: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.A review of the sterilization records for the device verified that the lot met all pre-release specifications.
Additional Manufacturer Narrative
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 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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.

• Brand Name: GORE SYNECOR INTRAPERITONEAL BIOMATERIAL
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10063515
• Report Number: 3003910212-2020-00099
• Device Sequence Number: 11648841
• Product Code: FTL
• UDI-Device Identifier: 00733132635344
• UDI-Public: 00733132635344
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

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: 11/05/2022
• Device Model Number: GKFC12
• Device Catalogue Number: GKFC12
• Device Lot Number: 21496599
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/10/2020; 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 76 YR
• Patient Weight: 82