BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3230393 · Received July 16, 2013

    Report

    Report Number
    2134265-2013-04859
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. EVENT DATE: 2011. IF IMPLANTED, GIVE DATE: 2011. 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 POST A PERCUTANEOUS CORONARY INTERVENTION, IN-STENT RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE DIAGONAL ARTERY. A 2.25MM X 8MM PROMUS ELEMENT STENT WAS DEPLOYED IN THE TARGET LESION. FOLLOWING DEPLOYMENT THE STENT WAS "BLOCKED" AND WAS TREATED USING A NON-BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329411 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911308220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention