BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY¿

    MDR report key: 6088379 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-09709
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID: 2134265-2016-09706, 2134265-2016-09707, 2134265-2016-09708, 2134265-2016-09705, 2134265-2016-09710 IT WAS REPORTED THAT THE PATIENT DIED. THE STENOSED TARGET LESIONS WERE LOCATED IN THE 1ST DIAGONAL BRANCH ARTERY. A 4.00X32MM SYNERGY(TM) DRUG-ELUTING STENT WAS IMPLANTED IN THE OSTIUM. A 3.5X32MM SYNERGY(TM) DRUG-ELUTING STENT WAS IMPLANTED IN THE MIDDLE THIRD AND A 3.0X12MM SYNERGY(TM) DRUG-ELUTING STENT WAS IMPLANTED IN THE DISTAL THIRD. A 4X16MM SYNERGY(TM) DRUG-ELUTING STENT WAS IMPLANTED IN THE ANTERIOR DESCENDING. A 2.25X16MM AND 2.25X12MM SYNERGY(TM) DRUG-ELUTING STENTS WERE IMPLANTED IN THE DIAGONAL. NORMAL FLOW WAS OBTAINED WITH NO RESIDUAL STENOSIS. AORTIC VALVULOPLASTY WAS PERFORMED WITH A BALLOON AND A 29MM NON BSC TRANSCATHETER HEART VALVE PROSTHESIS WAS IMPLANTED. THERE WAS OCCLUSION AT THE OSTIUM OF THE LEFT CORONARY TRUNK. "REVERSION" OF EXTRACORPOREAL CIRCULATION (CEC) AND REVASCULARIZATION OF THE DIAGONAL ARTERY WITH SAPHENOUS GRAFT WAS PERFORMED. HOWEVER, THE PATIENT DID NOT COME OUT OF CEC AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741552 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926216400

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 29MM EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE