BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3232881 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04864
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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 UNPACKING FOR A CORONARY STENTING TREATMENT PROCEDURE, THE PACKAGING OF THE DEVICE WAS TORN. THE BOX AND POUCH OF A 2.50X12MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT WAS ALREADY TORN WHEN IT WAS TAKEN OFF THE SHELF. IT WAS THOUGHT THAT IT PROBABLY HAPPENED DURING SHIPMENT. THE STENT INSIDE THE BOX WAS TOTALLY "UNAFFECTED AND FINE". THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333454 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412250

    Patients

    Seq Age Sex Outcome Treatment
    1