BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 6080203 · Received November 4, 2016

    Report

    Report Number
    2134265-2016-09922
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED ON THE PROXIMAL MID LEFT ANTERIOR DESCENDING ARTERY. A 3.0X24 SYNERGY¿ DRUG-ELUTING STENT WAS IMPLANTED TO TREAT THE LESION. THE PATIENT WAS GIVEN ANGIOMAX AND EFFIENT. HOWEVER, 20 MINUTES POST PROCEDURE, THERE WAS STENT THROMBOSIS. THE THROMBUS WAS ASPIRATED AND POST DILATION WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729517 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention