BEUDAMED
    FDA Adverse Event Summary report: N

    RX HERCULINK PLUS

    MDR report key: 767388 · Received September 21, 2006

    Report

    Report Number
    767388
    Date Received
    September 21, 2006
    Date of Event
    September 13, 2006
    Report Date
    September 21, 2006
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    FGE
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A RENAL STENT WAS TO BE PLACED IN THE LEFT RENAL ARTERY. AN ANGIOPLASTY WIRE WAS ADVANCED TO THE LEFT RENAL ARTERY AND A GUIDANT HERCULINK PLUS 135CM, STENT 5.5MM X 18MM (LOT # 6061751) WAS ADVANCED TO THE SITE OF THE LESION. AS THE UNDEPLOYED STENT WAS BEING MANIPULATED TO THE EXACT LOCATION OF THE LESION, THE UNDEPLOYED STENT GOT CAUGHT ON WHAT APPEARED TO BE A PIECE OF CALCIUM IN THE MID PORTION OF THE VESSEL. THE RESULT WAS THE STENT SLIPPED OFF THE STENT DELIVERY SYSTEM HALF WAY IN THE LEFT RENAL ARTERY. THE ANGIOPLASTY WIRE WAS THEN ADVANCED TO THE LEFT RENAL ARTERY ALONG WITH THE WIRE AND UNDEPLOYED STENT. A SECOND GUIDANT HERCULINK PLUS 135CM, STENT 5.5MM X 18MM (LOT # 5021551) WAS ADVANCED TO THE LEFT RENAL ARTERY OVER THE WIRE AT THE SITE OF THE UNDEPLOYED STENT ALREADY IN THE VESSEL. THE SECOND HERCULINK STENT WAS DEPLOYED TO 10 ATM (UNIT OF MEASURE FOR ATMOSPHERIC PRESSURE AT SEA LEVEL) WITH THE WIRE AND THE FIRST UNDEPLOYED STENT IN PLACE. AFTER THE STENT WAS DEPLOYED THE WIRE AND THE FIRST HERCULINK STENT DELIVERY SYSTEM WERE REMOVED. THE RESULT WAS THE FIRST STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH THE SECOND STENT. ANOTHER STENT WAS PLACED PROXIMAL TO THE DEPLOYED STENT AND BOTH STENTS WERE POST DILATED WITH A BALLOON. THE PROCEDURE WAS SUCCESSFUL AND NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK PLUS STENT, BILIARY FGE GUIDANT CORPORATION * 6061751

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR