BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3180327 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04438
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: 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 PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGED OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 90% TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING(LAD) ARTERY. DURING ADVANCEMENT OF A 3.00X16MM PROMUS ELEMENT PLUS DRUG ELUTING STENT RESISTANCE WAS ENCOUNTERED AND THE DEVICE WAS REMOVED INTACT. UPON REMOVAL IT WAS NOTED THAT ONE-THIRD OF THE STENT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. IT WAS SUSPECTED THAT THE COMPLAINT DEVICE MIGHT HAVE COME IN CONTACT WITH THE EDGE OF THE NON BSC STENT THAT HAD BEEN PREVIOUSLY BEEN IMPLANTED IN THE FIRST DIAGONAL, AS THE EDGE OF THIS STENT CAME OUT INTO THE MAIN LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281300 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416300 15861141

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE STENT