BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 8256386 · Received January 17, 2019

    Report

    Report Number
    2134265-2019-00095
    Event Type
    Death
    Date Received
    January 17, 2019
    Date of Event
    November 18, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OLDER. DEVICE IS COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OF AGE OR OLDER. DEVICE IS COMBINATION PRODUCT. DATE OF DEATH CORRECTED FROM (B)(6) 2018 AS THE PATIENT WAS RELEASED FROM THE HOSPITAL 5 DAYS POST PROCEDURE AND EXPIRED 1 OR 2 DAYS LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPIRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. A 3.00X16 SYNERGY DRUG ELUDING STENT WAS IMPLANTED IN THE PATIENTS MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND FIVE DAYS POST PROCEDURE EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPIRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. A 3.00X16 SYNERGY DRUG ELUDING STENT WAS IMPLANTED IN THE PATIENTS MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND FIVE DAYS POST PROCEDURE EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME. IT WAS FURTHER REPORTED THE PATIENT WAS DISCHARGED ON THE FIFTH DAY AFTER THE OPERATION AND EXPIRED 1 OR 2 DAYS LATER. THE PHYSICIAN COMMENTED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE DEATH AND THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49698 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10618 0022124012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death