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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/01/2016

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2016 whereby a gore-tex® soft tissue patch was implanted.The complaint alleges that on (b)(6) 2016, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection.Additional event specific information was not provided.

Manufacturer Narrative

(b)(4).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be closed with the information provided.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.The alleged ¿gore-tex¿ mesh is being captured as gore-tex® soft tissue patch for product surveillance purposes.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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: 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.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.After multiple requests, product identification information was not provided for this device and thus it could not be confirmed to be a gore hernia device.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.

• Brand Name: GORE-TEX® SOFT TISSUE PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: rena gros ; 1500 n. 4th street; 9285263030
• MDR Report Key: 14885752
• MDR Text Key: 295126316
• Report Number: 3003910212-2022-00003
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female