BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 17659425 · Received August 31, 2023

    Report

    Report Number
    3005099803-2023-04660
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    April 25, 2012
    Report Date
    August 31, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729470274
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2012, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING PHYSICIAN IS: DR. (B)(6). (B)(6) MED CENTER. (B)(6). THE EXPLANTING PHYSICIAN IS: DR. (B)(6). (B)(6) HOSPITAL. (B)(6). BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E2006 - HAS BEEN USED TO CAPTURE THE REPORTED EVENT OF ERODED TENSION-FREE VAGINAL TAPE. E2314 - HAS BEEN USED TO CAPTURE THE REPORTED EVENT OF URETHROVAGINAL FISTULA. THE FOLLOWING IMDRF IMPACT CODES CAPTURE THE REPORTABLE EVENTS OF: F1905 - HAS BEEN USED TO CAPTURE THE REPORTED EVENT OF VAGINAL MESH EXCISION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL TAPE PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2012, FOR THE TREATMENT OF STRESS INCONTINENCE. NO COMPLICATIONS WERE OBSERVED DURING THE PROCEDURE, AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT UNDERWENT A BIOPSY ON (B)(6) 2022, TO ADDRESS A BOTHERSOME MASS IN HER URETHRA RESULTING FROM A URETHRAL DIVERTICULUM. DESPITE INCONCLUSIVE IMAGING, EXAMINATION IN THE CLINIC REVEALED PURULENT DISCHARGE AND MASS COMPRESSION. THE PATIENT OPTED FOR SURGICAL EXPLORATION TO CONFIRM THE SUSPECTED DIAGNOSIS. DURING THE EXAMINATION, THE DOCTOR NOTICED A LARGER AND FIRMER MASS ON THE SIDE OF THE URETHRA. THIS MASS HAD SHIFTED TOWARDS THE RIGHT FROM ITS PREVIOUS POSITION IN THE MIDDLE. TRYING TO COMPRESS THE MASS DID NOT REVEAL ANY FUNCTIONS, AND THERE WAS NO SIGN OF PUS IN THE MASS OR URETHRA. MOREOVER, A FISTULA HAD DEVELOPED BETWEEN THE URETHRA AND VAGINA SINCE THE LAST CHECK-UP. THE OPENING OF THE FISTULA WAS ABOUT 1-2 CM HIGHER THAN THE URETHRAL MEATUS, AND THE MUCOSA WAS HIGHLY FRIABLE. TO CONFIRM THE FISTULA, A 19 FRENCH CYSTOSCOPE WAS INSERTED INTO THE URETHRA. THE DOCTOR THOROUGHLY EXAMINED THE BLADDER BUT FOUND NO ABNORMALITIES. DURING THE PULLBACK, IT WAS CONFIRMED THAT THE PATIENT HAD A URETHRAL VAGINAL FISTULA. MOREOVER, THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2022, THE PATIENT UNDERWENT A PARTIAL EXCISION OF THE TENSION-FREE VAGINAL TAPE, URETHROVAGINAL FISTULA REPAIR WITH PLACEMENT OF MARTIUS FLAP, HARVESTING OF MARTIUS LABIAL FLAP FROM THE LEFT LABIA, AND CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT DUE TO ERODED TENSION-FREE VAGINAL TAPE WITH URETHROVAGINAL FISTULA. DURING THE PROCEDURE, THE SLING WAS CLAMPED ON BOTH SIDES, THEN DIVIDED IN THE MIDDLE AND SOME ADHERENT TISSUE WAS RELEASED FROM EACH SIDE OF THE SLING. THE PHYSICIAN AIMED TO PRESERVE SOME OF THE LATERAL ATTACHMENT OF THE SLING ON EACH SIDE TO HELP WITH FUTURE CONTINENCE. AFTER THAT, THE SLING WAS EXCISED ON BOTH SIDES, REMOVING APPROXIMATELY 2 CM OF IT. FOLLOWING THAT, THE PHYSICIAN INSPECTED THE TISSUES OF THE FISTULA AND FOUND SOME NOT-SO-HEALTHY-LOOKING TISSUE THAT NEEDED TO BE EXCISED. THE FISTULA WAS THEN CLOSED TRANSVERSELY BY REAPPROXIMATING THE PROXIMAL TO DISTAL EDGES USING CONTINUOUS 4-0 MONOCRYL. IN ADDITION, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389006 ADVANTAGE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502000 ML00000486 08714729470274

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention