BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY?

    MDR report key: 4162030 · Received October 10, 2014

    Report

    Report Number
    2134265-2014-06114
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 STENT DAMAGE OCCURRED. WHILE PREPARING A 24X2.50MM SYNERGY¿ DRUG-ELUTING STENT FOR USE, THE PHYSICIAN NOTED THAT THE STENT FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS 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
    643923 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919824250 16647915

    Patients

    Seq Age Sex Outcome Treatment
    1