BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1051054 · Received May 22, 2008

    Report

    Report Number
    9616695-2008-00080
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. NEUROLOGICAL COMPLICATION IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF CAROTID STENTS AS STATED IN THE XACT INSTRUCTIONS FOR USE. NO DEVICE MALFUNCTION WAS REPORTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    MALFUNCTION: NONE. SYMPTOMS/AE: NEUROLOGICAL EVENT - ETIOLOGY UNKNOWN. TIME OF SYMPTOMS: THIRTEEN DAYS POST PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 13 DAYS POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, THE PATIENT HAD COMPLAINTS OF WEAKNESS, IMPAIRED SPEECH (SLOW BUT CLEAR) AND DIFFICULTY AMBULATING. SIXTEEN DAYS POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE ETIOLOGY OF THE SYMPTOMS REMAIN UNCLEAR AS THE PATIENT HAS ALZHEIMER'S WITH DEMENTIA AND PRESENTED TO THE HOSPITAL WITH HYPERCALCEMIA. A HEAD CT WAS NEGATIVE AND AN MRI SHOWED ONLY MILD CHRONIC SMALL VESSEL ISCHEMIC CHANGES. TWENTY SIX DAYS POST PROCEDURE, THE SYMPTOMS AND THE HYPERCALCEMIA RESOLVED AND THE PATIENT WAS DISCHARGED BACK TO THE NURSING FACILITY SHE CAME FROM. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 444727

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization EMBOSHIELD EMBOLIC PROTECTION DEVICE| HEPARIN