BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 800089 · Received December 22, 2006

    Report

    Report Number
    3004742046-2006-00548
    Event Type
    Injury
    Date Received
    December 22, 2006
    Date of Event
    November 16, 2006
    Report Date
    December 5, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    p040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: HYPOTENSION, BRADYCARDIA, MYOCARDIAL INFRACTION. TIME OF SYMPTOMS/AE: DURING THE PROCEDURE, POST STENT DEPLOYMENT AND DILITATION. IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE LEFT INTERNAL CAROTID ARTERY, THE PATIENT EXPERIENCED PERSISTENT HYPOTENSION AFTER STENT DEPLOYMENT AND DILITATION. THE PATIENT RECEIVED BLOOD TRANSFUSIONS AND ALL HER BLOOD PRESSURE MEDICATIONS WERE STOPPED. SUBSEQUENTLY, BLOOD PRESSURE CAME UP AND THE PATIENT WAS DISCHARGED TO HOME TWO DAY LATER IN STABLE CONDITION. ADDITIONALLY, THE PATIENT EXPERIENCED BRADYCARDIA AFTER POST DILITATION, WHICH WAS MEDICALLY MANAGED. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL ER THREE DAYS LATER DUE TO WEAKNESS, FOUND TO BE HYPOTENSIVE AND HAD A BUMP IN TROPONIN (NON-Q MI). THE PATIENT REMAINED ASYMPTOMATIC AFTER ADMISSION FROM THE ER; CARDIAC ENZYMES TRENDED DOWNWARDS AND SHE WAS DISCHARGED TO HOME IN STABLE CONDITION. IT IS NOTED THAT THE PATIENT'S CONDITION RESOLVED IN 2006. 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 6053151

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention OTHER: RX ACCUNET| SHEATH: SUPER SHEATH| GUIDE WIRE: J WIRES.035 145CM FIXED CORE (X2)| DILITATION CATHETER: FR4 6FR| GUIDE CATHETER:MP 1