BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® SOFT TISSUE PATCH

    MDR report key: 3971514 · Received July 31, 2014

    Report

    Report Number
    2017233-2014-00396
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    January 3, 2003
    Report Date
    July 2, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTL
    PMA / PMN Number
    K963619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL DETAILS REGARDING THE PATIENT'S CLINICAL COURSE WE ASCERTAINED FROM A REVIEW OF MEDICAL RECORDS AND ARE AS FOLLOWS: OPERATIVE REPORT (B)(6) 2001: ABDOMINAL SACRAL COLPOPEXY IN WHICH GORE-TEX® SOFT TISSUE PATCH WAS USED, OBLITERATION OF CUL-DE-SAC, HALBAN PROCEDURE POSTERIOR COLPORRHAPHY , ABDOMINAL LYSIS OF ADHESIONS AND PERINEOPLASTY. MEDICAL RECORD DATED (B)(6) 2001: INDICATES ¿I CAN PALPATE THE GORE-TEX GRAFT ON THE UPPER SIDE OF THE VAGINA, BUT I DO NOT NOTE THAT THE GRAFT HAS ERODED THROUGH THE VAGINA AND APPEARS TO BE IN PROPER POSITIONING. THERE IS ONE PROLENE SUTURE THAT I CAN FEEL AT THE TOP OF THE VAGINA, BUT THERE OTHERWISE APPEARS TO BE EXCELLENT SUPPORT, AND AT THIS POINT WILL LEAVE THAT INTACT FOR NOW UNLESS THE PATIENT DEVELOPS FURTHER PROBLEMS.¿ MEDICAL RECORD (B)(6) 2002: PATIENT ¿¿IS NOT HAVING ANY SYMPTOMS OF PELVIC RELAXATION AND FEELS ABDOMINAL PROCEDURE WORKED MUCH BETTER.¿ ¿I DO NOT SEE ANY EVIDENCE OF THE GORE-TEX GRAFT. I DO FEEL A PERMANENT PROLENE SUTURE COMING THROUGH BUT THE PATIENT IS ASYMPTOMATIC FROM THIS SO IT WAS LEFT INTACT.¿ EXCELLENT SUPPORT OF THE APEX WAS NOTED. MEDICAL RECORD (B)(6) 2002 INDICATES: ¿I CAN STILL PALPATE THE GORE-TEX GRAPH IN THE UPPER RIGHT HAND SIDE OF THE VAGINA, BUT IT DOES NOT APPEAR TO HAVE ERODED THROUGH AND THERE IS GOOD SUPPORT OF THE VAGINAL APEX [(B)(6)].¿ MEDICAL RECORD (B)(6) 2003 INDICATES: PATIENT IS EVALUATED FOR EVALUATION FOR BLOODY DISCHARGE. ¿I COULD NOT SEE ANY EVIDENCE OF BLEEDING FROM VAGINAL, BUT AFTER REMOVING THE SPECULUM AND PALPATING THE TOP OF THE VAGINA AT THE CUFF, I WAS ABLE TO PALPATE THE GORE-TEX GRAFT WHICH NOW APPEARS TO HAVE ERODED THROUGH THE VAGINA [(B)(6)].¿ MEDICAL RECORDS DATED (B)(6) 2003 INDICATES: EXAMINATION REVEALED PROLENE SUTURE AT THE TOP OF THE VAGINAL APEX. MEDICAL RECORDS DATED (B)(6) 2003: ON EXAM ¿¿THE GRAFT IS MUCH MORE VISIBLE THAT IT HAD BEEN PREVIOUSLY, AND IT IS TO THE POINT WHERE IT IS ALMOST COMPLETELY REJECTING AT THE TOP OF THE CUFF.¿ ¿¿I WOULD WANT TO SEND HER SOMEWHERE WHERE SHE COULD HAVE AN AUTOLOGOUS GRAFTING DONE, BECAUSE IT IS APPARENT THAT SHE APPEARS TO REJECT ALL FOREIGN MATERIALS, SINCE SHE PREVIOUSLY HAD REJECTED THE PROLENE SUTURES WITH THE SACROSPINOUS FIXATION AS WELL.¿ A PORTION OF THE GRAFT WAS EXCISED IN THE OFFICE. MEDICAL RECORD (B)(6) 20/03 INDICATES ¿¿MORE OF THE GORE-TEX HAD PROTRUDED THROUGH THE VAGINAL APEX.. I GRASPED ONTO IT AND REMOVED IT WITH ONE PULL ON SUTURE [(B)(6)].¿ (B)(6) 2003. MEDICAL RECORDS DATED (B)(6) 2003 INDICATES: ¿BIMANUAL EXAM WAS DONE AND THIS REVEALED AN AREA AT THE VAGINAL APEX WHICH APPEARS TO HAVE A PIN POINT OPENING. I SUSPECT THIS IS A SMALL TRACT WHERE THE GORE-TEX HAD COME THROUGH AND IT HAS NOT SEALED OVER.¿ MEDICAL RECORD DATED (B)(6) 2004 INDICATES: ¿WITH FURTHER PRYING USING THE BOZEMAN FORCEPS, I CAN SEE EVIDENCE OF THE GORE-TEX GRAFT WITHIN THE SMALL SINUS TRACT. I GRASPED ONTO IT AND ALSO WITH THE ASSISTANCE OF A RING FORCEPS BROUGHT OUT APPROXIMATELY 3 CM OF THE GRAFT AT WHICH TIME IT WOULD COME NO FURTHER TO SECONDARY TO ITS ATTACHMENT ONTO THE SACRAL AREA. THIS WAS THEN CUT.¿ MEDICAL RECORDS DATED (B)(6) 2006 INDICATES: ¿I DID SEE A SMALL AREA THAT REVEALED BLUE SUTURES CONSISTENT WITH THE PROLENE THAT WAS PUT IN WITH THE GORE-TEX GRAFT. I GRASPED ONTO THIS AND WHAT I SUSPECT TO BE THE REMAINING PORTION OF THE GORE-TEX GRAFT WAS REMOVED THROUGH A SMALL DEFECT IN THE APEX OF THE VAGINA WHICH WAS NO MORE THAN 0.5 CM IN DIAMETER.¿ ¿¿I DO FEEL THAT THIS IS THE REMAINING ENTIRETY OF THE GRAFT.¿ MEDICAL RECORD DATED (B)(6) 2006 INDICATES: ¿THE VAGINAL CUFF IS INTACT.¿ THE MANUFACTURING RECORDS FOR THIS LOT ARE BEYOND THE REQUIRED RETENTION PERIOD AND THEREFORE, CANNOT BE REVIEWED.  ALTHOUGH DOCUMENTS ARE UNAVAILABLE, STANDARD MANUFACTURING PROCEDURES REQUIRE LOT HISTORY REVIEW BEFORE RELEASE OF THE DEVICE TO ENSURE COMPLIANCE WITH DEVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THAT A PATIENT ALLEGES TO HAVE EXPERIENCED ABDOMINAL PAIN, EROSION, DYSPAREUNIA, ODOR AND URINARY PROBLEMS AFTER ALLEGEDLY HAVING BEEN IMPLANTED WITH A GORE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447389 GORE-TEX® SOFT TISSUE PATCH MESH, SURGICAL, POLYMERIC FTL W.L. GORE & ASSOCIATES P14280-063

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention