BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2072119 · Received April 28, 2011

    Report

    Report Number
    2134265-2011-01501
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS PREDILATED WITH A NON-BSC BALLOON THEN THE 24X2.25MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE TARGET LESION. THE DEVICE WAS REMOVED AND A STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH AN 18X2.25MM NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 13717639

    Patients

    Seq Age Sex Outcome Treatment
    1 MINI TREK BALLOON