BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 929552 · Received October 19, 2007

    Report

    Report Number
    3004742046-2007-00321
    Event Type
    Death
    Date Received
    October 19, 2007
    Date of Event
    August 7, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN THE PATIENT'S ANATOMY. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE FINISHED DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DEATH. TIME OF SYMPTOMS/AE: 48 DAYS POST PROCEDURE. IT WAS REPORTED THAT THE PATIENT DIED, ON 8/7/2007, 48 DAYS AFTER A RIGHT INTERNAL CAROTID ARTERY (RICA) STENTING PROCEDURE. THE PATIENT DIED AT HOME AND THE CAUSE OF DEATH COULD NOT BE PROVIDED. AUTOPSY WAS NOT PERFORMED. THE PATIENT HAD PLANNED TO UNDERGO A CORONARY ARTERY BYPASS GRAFT WITHIN 30 DAYS OF THE RICA PROCEDURE BUT HAD NOT DONE, SO DUE TO MULTIPLE PRE-EXISTING MEDICAL PROBLEMS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7021451

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death