BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2287458 · Received February 16, 2011

    Report

    Report Number
    2287458
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INJURY TO ILIAC ARTERY SUSTAINED DURING CORONARY STENT MANEUVER. CORONARY STENT BECAME LODGED IN ARTERY. DURING ATTEMPT TO REMOVE IT, INJURY OCCURRED TO THE ILIAC ARTERY. EMERGENT OPEN SURGERY TO REPAIR TEAR. PT EXPIRED FOUR DAYS POST-EVENT. STENT WAS NOT RETRIEVED INTRA-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR VISION RX STENT, 3.0 X 23 MAF ABBOTT VASCULAR 0110941

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death