BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY? II

    MDR report key: 3894446 · Received June 25, 2014

    Report

    Report Number
    2134265-2014-04153
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. A 2.25X20MM SYNERGY STENT WAS SELECTED TO TREAT AN UNSPECIFIED LESION LOCATION. THE PHYSICIAN PROCEEDED TO IMPLANT THE SYNERGY STENT; HOWEVER, THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE SYNERGY STENT DELIVERY SYSTEM WAS REMOVED WITHOUT THE STENT. ANGIO WAS PERFORMED IN ATTEMPTS TO LOCATED THE STENT AND WERE UNSUCCESSFUL. THE PHYSICIAN LOOK OUTSIDE THE PATIENT FOR THE MISSING STENT AND THE STENT COULD NOT BE FOUND. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371388 SYNERGY? II CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926220220 16436533

    Patients

    Seq Age Sex Outcome Treatment
    1