BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR

    MDR report key: 1636003 · Received March 16, 2010

    Report

    Report Number
    MW5015183
    Event Type
    Death
    Date Received
    March 16, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 10, 2010
    Manufacturer
    ABBOTT VASCULAR, INC.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MD PLACED COR WIRE DOWN 100% AFFECTED ARTERY. BALLOON DILATATION PERFORMED SLIGHT STAIN NOTICED, NO FLOW DOWN ARTERY CONTINUING. STENT PLACED IN ARTERY AND DEPLOYED. CARDIAC TAMPONADE, PERICARDIAL CENTESIS PERFORMED. SURGERY DECLINED. PATIENT EXPIRED. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ACUTE CORONARY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR MINI VISION MAF ABBOTT VASCULAR, INC. 2.5X23 OTW 9072431

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death