BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160086 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02681
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    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 STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION AS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED AND THEN A 2.75X20MM PROMUS ELEMENT STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION AT NOMINAL PRESSURE; HOWEVER, IT WAS NOTED THAT AFTER DEPLOYMENT, THE STENT "SHRUNK" LENGTH WISE. THE LESION WAS POSTDILATED AND THEN ANOTHER PROMUS ELEMENT STENT WAS DEPLOYED IN THE LESION TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 14027453

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR