BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 827867 · Received March 2, 2007

    Report

    Report Number
    3004742046-2007-00079
    Event Type
    Injury
    Date Received
    March 2, 2007
    Date of Event
    January 24, 2007
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    p040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND RX ACCULINK, 1011342-30, 5121351, AS INDICATED IN THE EVENT DESCRIPTION AND IN D11, AND IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION, MENTAL STATUS CHANGE. TIME OF SYMPTOMS/AE: 43 DAYS POST-PROCEDURE. IT WAS REPORTED THAT ONE DAY POST LEFT COMMON AND INTERNAL CAROTID ARTERY STENTING, THE PATIENT EXPERIENCED TRANSIENT DISORIENTATION THAT RESOLVED THE SAME DAY. CT OF THE HEAD SHOWED NO NEW CHANGES. NIHSS SCORE WAS 0 AND A NEUROLOGY EXAMINATION, DONE THE SAME DAY WAS NORMAL. FORTY THREE DAYS POST-PROCEDURE, AT THE 30 DAY FOLLOW-UP VISIT, THE PATIENT COMPLAINED OF RECENT MENTAL STATUS CHANGE WITH DIFFICULTY "CARRYING ON CONVERSATION", DECREASED WORD FINDING, AND DECREASED MEMORY. HIS NIHSS SCORE WAS 2 AND HIS BLOOD PRESSURE WAS LOW, IN THE 80S TO 90S. BOTH THE INVESTIGATOR AND NEUROLOGIST FELT THE MENTAL STATUS CHANGES WERE DUE TO HYPOTENSION. THE PATIENT HAD RECENTLY SEEN HIS CARDIOTHORACIC SURGEON AND WAS TOLD HIS PACEMAKER BATTERY WAS LOW AND NEEDED REPLACEMENT. THE PATIENT HAS HISTORY OF HYPOTENSION/SYNCOPE WHEN THE BATTERY IS LOW. THE INVESTIGATOR STATED THAT MORE THAN LIKELY THE HYPOTENSION WAS RELATED TO LOW PACEMAKER BATTERY, BUT COULD NOT RULE OUT BARORECEPTOR RESPONSE WITH CAROTID PROCEDURE WITH PATIENT'S HISTORY OF HYPERTENSIVE MEDS, WHICH HAVE HAD TO BE ADJUSTED IN THE PAST. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6031451

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability RX ACCUNET| RX ACCULINK