BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2171634 · Received July 21, 2011

    Report

    Report Number
    2134265-2011-02786
    Event Type
    Injury
    Date Received
    July 21, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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 TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON. AN ION STENT WAS SUCCESSFULLY DEPLOYED IN THE UNSPECIFIED LESION AND THE PHYSICIAN ATTEMPTED TO DEPLOY A SECOND ION STENT DISTAL TO THE FIRST ONE. WHILE ADVANCING THE STENT DELIVERY SYSTEM (SDS) THROUGH THE PREVIOUSLY PLACED STENT, THE PHYSICIAN FELT THAT THE STENT WAS COMING OFF OF THE BALLOON AND HAD TO DEPLOY THE STENT INSIDE THE PREVIOUSLY PLACED STENT. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ION STENT