BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3002398 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01709
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. AGE AT TIME OF EVENT - 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, STENT DAMAGE OCCURED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER, THE PHYSICIAN ATTEMPTED TO CROSS THE BIFURCATION OF THE POSTERIOR DESCENDING ARTERY AND POSTERIOR LATERAL USING A 2.5MM X 12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE SDS WAS REMOVED IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106113 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412250 15609951

    Patients

    Seq Age Sex Outcome Treatment
    1