BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUFLEX PLUS URETERAL STENT

    MDR report key: 1040082 · Received May 7, 2008

    Report

    Report Number
    3005099803-2008-00433
    Event Type
    Injury
    Date Received
    May 7, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION CANNOT BE PERFORMED SINCE THE DEVICE WAS DISPOSED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THREE PERCUFLEX STENTS WERE USED IN THE FOLLOWING EVENTS. IN 1999, A MALE UNDERWENT A MILES OPERATION AND ADJUVANT IRRADIATION THERAPY FOR RECTUM CANCER. AS A RESULT OF THIS THERAPY, THE PT SUFFERED FROM BILATERAL URETAL STRICTURES. BILATERAL DOUBLE J URETERAL STENTS WERE INSERTED AND EXCHANGED AT REGULAR INTERVALS. FOUR YEARS AFTER THE START OF THE PT STENTING, THE PT EXPERIENCED GROSS HEMATURIA AND DYSURIA. THE PT RETURNED TO THE HOSPITAL FOR "EVACUATION OF THE BLADDER FAILURE." WHEN THE RIGHT DOUBLE J STENT WAS EXCHANGED, MASSIVE BLEEDING FROM THE EXTERNAL OPENING OF THE URETHRA WAS OBSERVED. RETROGRADE PYELOGRAPHY REVEALED RIGHT URETERO - ILIAC ARTERIAL FISTULA. SINCE STENT TREATMENT WAS INEFFECTIVE, THE PHYSICIAN PERFORMED RIGHT COMMON ILIAC ARTERY EMBOLIZATION AND FEMORAL - FEMORAL ARTERY BYPASS. TWO DAYS POST PROCEDURE, GROSS HEMATURIA DEVELOPED. WHEN THE LEFT URETERAL STENT WAS EXCHANGED, ACTIVE BLEEDING FROM THE EXTERNAL MEATUS OF THE URETHRA WAS ALSO NOTED. ANGIOGRAPHY SHOWED EXTRAVASATION FROM THE LEFT COMMON ILIAC ARTERY. THE PT WAS DIAGNOSED WITH LEFT URETERO-ILIAC ARTERIAL FISTULA. FINALLY RIGHT AXILLO FEMORAL ARTERY BYPASS WAS PERFORMED WHICH HAS ACHIEVED LONG TERM GOOD CONTROL OF THE URETERO ARTERIAL FISTULA. PLEASE REFERENCE MEDWATCH REPORT #: 3005099803-2008-00418 FOR DOCUMENTATION OF THE FIRST STENT AND MEDWATCH REPORT #: 3005099803-2008-00432 FOR DOCUMENTATION OF THE THIRD STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX PLUS URETERAL STENT FGE BOSTON SCIENTIFIC CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention