BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1582021 · Received January 15, 2010

    Report

    Report Number
    3004742046-2010-00020
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    December 2, 2009
    Report Date
    December 30, 2009
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO RX ACCULINK DEVICE MALFUNCTION REPORTED. NEUROLOGICAL EVENTS AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE AS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/ AE: NEUROLOGICAL EVENT AND DEATH. TIME OF AE: APPROXIMATELY 16-45 DAYS POST-PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 16 DAYS POST AN UNEVENTFUL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPERIENCED GENERALIZED WEAKNESS WITH DECREASED ORAL INTAKE. IN 2009, THE PATIENT WAS HOSPITALIZED WITH ALTERED MENTAL STATUS. LABORATORY FINDINGS INCLUDED AN ELEVATED CPK, CREATININE AND WHITE BLOOD COUNT. TREATMENT INCLUDED INTRAVENOUS FLUIDS AND BICARBONATE, BUT THE CREATININE CONTINUED TO ELEVATE. REPORTEDLY, THE CONDITION WAS CHRONIC. PROGNOSIS WAS POOR AND THE FAMILY REQUESTED AGGRESSIVE MEASURES STOPPED. SIXTEEN DAYS LATER, THE PATIENT WAS ADMITTED INTO THE CARE OF HOSPICE AND SIX DAYS LATER, THE PATIENT EXPIRED. THE EXACT CAUSE OF DEATH IS UNKNOWN AS A POSTMORTEM EXAMINATION WAS NOT PERFORMED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8011751

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death