BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1163547 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02683
    Event Type
    Death
    Date Received
    September 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT 488 DAYS FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PT EXPIRED. THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION AT THE TIME OF THE INDEX PROCEDURE. THE INDEX PROCEDURE TREATED THE 3.0X20MM, 100% OCCLUDED, DE NOVO MID LAD (LEFT ANTERIOR DESCENDING) WITH PREDILATION AND PLACEMENT OF A 3.0X20MM EXPRESS2 BARE METAL STENT RESULTING IN 0% RESIDUAL STENOSIS. DURING THIS PROCEDURE, THE 70% STENOSED 1ST DIAGONAL WAS ALSO TREATED WITH BALLOON ANGIOPLASTY ONLY RESULTING IN 20% RESIDUAL STENOSIS. THE PT PRESENTED 488 DAYS FOLLOWING THE INDEX PROCEDURE FOLLOWING AN ABRUPT LOSS OF CONSCIOUSNESS AT HOME. NO CLINICAL CONDITION PROCEEDED THE EVENT. THE PT WAS PULSELESS AND BREATHLESS. CPR WAS PERFORMED BY A FAMILY MEMBER AND HEALTH PROFESSIONALS. VENTRICULAR FIBRILLATION WAS OBSERVED ON ECG AND DEFIBRILLATION WAS REPEATEDLY PERFORMED. THE PT WAS RESUSCITATED, BUT AGAIN WENT INTO CIRCULATORY ARREST. FOLLOWING SEVERAL ADDITIONAL ATTEMPTS AT RESUSCITATION, THE PT WAS DECLARED DEAD. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF - STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 8125952

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death