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

Device Problems Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to obtain additional information regarding each patient, however no information has been provided.

Event Description

It was reported by the product specialist that a live clinical discussion session took place on (b)(6) 2020 via web conferencing.The session presented by (b)(6), md was titled "case experience and clinical data in over 250 cases using a hybrid biomaterial for hernia repair".In a later review of the presentation, the product specialist noted that after the presentation and during question and answering the physician stated that one or two infections had occurred and the device was excised.Gore was able to confirm with the physician that the product that was excised was gore® synecor intraperitoneal biomaterial.

Manufacturer Narrative

Additional device codes and conclusion codes added.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 (-z): 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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10192523
• MDR Text Key: 201157841
• Report Number: 3003910212-2020-00110
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K152609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention