BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA¿

    MDR report key: 3051327 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02247
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY(SFA). THE PHYSICIAN USED AN INTRODUCTOR 6FR AND THE UNSPECIFIED GUIDEWIRE PASSED THROUGH THE LESION WITHOUT ANY DIFFICULTY. A PREDILATATION WAS PERFORMED WITH A MUSTANG PTA BALLOON DILATATION CATHETER 5X80X75MM THE STENT INNOVA WAS POSITIONED. THE PHYSICIAN ROTATED THE THUMBWHEEL UNTIL THE MIDDLE OF THE STENT AND FINISHING USING THE PULL GRIP. THE TRACTION WAS DIFFICULT. WHEN THE STENT WAS FULLY DEPLOYED THE PHYSICIAN OBSERVED AN ABNORMAL STRETCHING IN THE MIDDLE OF THE STENT, CONSEQUENTLY THE STENT WAS LONGER THAN 200MM. AS THE RADIAL STRENGTH WASN'T ENOUGH IN THIS STRETCHING PART THE PHYSICIAN IMPLANTED A MUSTANG 6-200 INSIDE THE INNOVA 7X200MM. THE INNOVA IS LONGER THAN THE MUSTANG (AROUND 6 OR 7 EXTRA MM). NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149068 INNOVA¿ CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74939180072070 15316361

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention