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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE-TEX® SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
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.

 
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Brand NameGORE-TEX® SOFT TISSUE PATCH
Type of DeviceMESH, 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 Key10074546
MDR Text Key191566600
Report Number3003910212-2020-00101
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK963619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
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 TREATMENT DATA
Date Received: 05/20/2020 Patient Sequence Number: 1
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