BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3192475 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04219
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). 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 PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50MM X 16MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED AT 11 ATMS IN THE TARGET LESION. UPON POST-DILATION USING A 4.00MM X 12MM NON-BSC BALLOON CATHETER, THE PROXIMAL PORTION OF THE IMPLANTED STENT WAS COMPRESSED LONGITUDINALLY AT "APPROXIMATELY 4 TO 6MMS." A 4.00MM X 12MM PROMUS ELEMENT PLUS STENT WAS THEN PLACED OVER THE LONGITUDINALLY COMPRESSED AREA OF THE FIRST IMPLANTED STENT AND EXTENDED PROXIMALLY IN THE PROXIMAL LAD. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294840 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416350 16028898

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention BALLOON CATHETER: .00 X 12MM MEDTRONIC NC SPRINTER