BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6190328 · Received December 20, 2016

    Report

    Report Number
    2134265-2016-11683
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    UDI-DI
    08714729840237
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UPPER 50'S. 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# 2134265-2016-11682, 2134265-2016-11685, AND 2134265-2016-11684. IT WAS REPORTED THAT BLOOD FLOW OBSTRUCTION POST STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOLLOWING PRE-DILATATION, FOUR SYNERGY II DRUG-ELUTING STENTS SIZED 2.50 X 24, 3.00 X 24, 2.75 X 20, AND 3.00 X 16 WERE IMPLANTED TO TREAT THE LESION. HOWEVER, POST STENT DEPLOYMENT, BLOOD FLOW TO THE DISTAL LAD AND SEVERAL PROXIMAL DIAGONAL BRANCHES OF THE LAD WAS SHUT OFF. SUBSEQUENTLY, THE PATIENT HAD TO BE DEFIBRILLATED WHEN BLOOD FLOW WAS LOST. THE PROXIMAL VESSEL WAS OPENED, THE PATIENT'S RHYTHM WAS RESTORED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS KEPT ON ANGIOMAX DRIP TO OPEN THE DISTAL LAD AND A BALLOON PUMP WAS PLACED FOR 48 HOURS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842031 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926024300 19660585 08714729840237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention