BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY?

    MDR report key: 4132896 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-05833
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    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 EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS CAUSED BY OTHER DEVICE. (B)(4).

    Description of Event or Problem · 1

    POST A STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. THE TARGET LESION WAS LOCATED IN A MIDDLE SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO OVERLAPPED SYNERGY STENTS WERE IMPLANTED (2.25X24MM + 3X20MM) WITH GOOD ANGIOGRAPHIC RESULTS. A NON BSC INTRAVENOUS ULTRASOUND CATHETER (IVUS) WAS USED AND WHILE RETRIEVING THE IVUS PROBE FROM THE DISTAL LAD THROUGH THE STENTS, SOME RESISTANCE WAS FELT AT DISTAL EDGE OF THE DISTAL SYNERGY STENT. ANGIOGRAPHIC IMAGE AFTER IVUS PULLBACK SHOWED LONGITUDINAL DISTORTION OF THE DISTAL EDGE OF THE DISTAL STENT (2.25X24MM). THE PATIENT REMAINED ASYMPTOMATIC WITH NO FLOW IMPAIRMENT. THE FOLLOWING DAY THE PATIENT WAS TREATED WITH FURTHER BALLOON DILATATION AND AN ADDITIONAL STENT IMPLANTATION AT THE DISTAL EDGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612801 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926224220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention