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

Device Problems Off-Label Use (1494); Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017)

Patient Problem Internal Organ Perforation (1987)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Event date is date of the publication.Patient information was requested, but not provided.Item number/lot serial number were requested, as well as implant and explant date, however no information has been provided.[(b)(4)].

Event Description

The following publication was reviewed: (space-making particle therapy for sarcomas derived from the abdominopelvic region).Background: the primary definitive treatment for abdominopelvic sarcomas (apss) is resection, although incomplete resection has a negative prognostic impact.Although the effectiveness of particle therapy (pt) as a treatment for aps has already been demonstrated, its application for tumors adjacent to the gastrointestinal tract is frequently restricted, due to extremely low tolerance.Space-making pt, consisting of surgical spacer placement and subsequent pt, has been developed to overcome this limitation.Materials and methods: between june 2006 and june 2018, a total of 75 patients with 12 types of aps underwent space-making pt.59 patients had gore-tex sheet placement.Of the 59 patients who underwent gore-tex sheet placement, four also underwent a simultaneous gastrointestinal tract resection.Gore-tex sheets were inserted and sutured tightly to the surrounding tissue at the ventral side of the tumor.The article reported that one patient developed gastrointestinal perforation 8 years after surgical space placement, and the gore-tex sheets were removed.The gore-tex sheets have been confirmed by gore to be gore-tex® soft tissue patch.

• 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: cheryl hawke ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10074546
• MDR Text Key: 191566600
• Report Number: 3003910212-2020-00101
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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