BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1743115 · Received June 29, 2010

    Report

    Report Number
    3004742046-2010-00288
    Event Type
    Death
    Date Received
    June 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 4, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4): THE STENT REMAINS IN THE PATIENT. THE STENT DELIVERY SYSTEM HAS BEEN DISCARDED. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: 14 DAYS AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT 14 DAYS POST AN UNEVENTFUL CAROTID PROCEDURE, THE (B) (6) PT EXPIRED FROM DEEP VEIN THROMBOSIS (DVT) AND PNEUMONIA. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9112151

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death LOT# 9120951| HEPARIN| EMBOLIC PROTECTION: RX ACCUNET, 1011649-55