BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 5476089 · Received March 3, 2016

    Report

    Report Number
    2134265-2016-01326
    Event Type
    Injury
    Date Received
    March 3, 2016
    Date of Event
    February 7, 2016
    Report Date
    February 8, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT ADDRESS: (B)(6). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). 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: 2134265-2016-01325. IT WAS REPORTED THAT STENT INADEQUATE APPOSITION AND MYOCARDIAL INFARCTION OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE POSTERIOR LEFT VENTRICULAR (PLV) BRANCH AND POSTERIOR DESCENDING ARTERY (PDA) GOING ACROSS THE PLV AND INTO THE DISTAL RIGHT CORONARY ARTERY (RCA). A 2.25X16 AND A 2.25X20 SYNERGY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT THE LESIONS. THE PHYSICIAN DID NOT USE POST DILATATION BALLOONS FOLLOWING STENT DEPLOYMENT. HOWEVER, THERE WAS EVIDENT OSTIAL PLV STENOSIS POST PLACEMENT OF THE STENTS ACROSS THE PLV BRANCH EXTENDING FROM PDA TO DISTAL RCA. THE PHYSICIAN DID NOT RECROSS THE STENT TO OPEN UP THE STENOSIS AND THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. FIVE DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE MALAPPOSED STENT IN THE PLV BRANCH WAS POST DILATED WITH A BALLOON AND PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED IN THE OSTIAL PLV. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134632 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926220220 17820939

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention