BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 809492 · Received January 23, 2007

    Report

    Report Number
    3004742046-2007-00032
    Event Type
    Injury
    Date Received
    January 23, 2007
    Date of Event
    November 29, 2006
    Report Date
    January 2, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, PRODUCT PERFORMANCE GROUP ATTEMPTED TO OBTAIN COMPLETE EVENT INFO, INCLUDING PT INFO AND PT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. THE SECOND RX ACCULINK CAROTID STENT SYSTEM, PART# 1011343-40, LOT# 6071852 IS INDICATED, AND IS BEING FILED UNDER MFR REPORT NUMBER 3004742046-2007-00031.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: MYOCARDIAL INFARCTION (MI). TIME OF SYMPTOMS/AE: SEVEN DAYS POST PROCEDURE. IT WAS REPORTED THAT THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI), SEVEN DAYS AFTER HAVING BILATERAL CAROTID PTA STENTING OF THE LEFT AND RIGHT INTERNAL CAROTID ARTERIES. THE PT WAS ADMITTED TO THE HOSP FOR ANTIBIOTIC TREATMENT OF LEUKOCYTOSIS AND DEBRIDEMENT OF MULTIPLE LIVER ABSCESSES. DURING HOSP ADMISSION, THE PT HAD A RISE IN CARDIAC ENZYMES CK, CK-MB AND TROPONIN-I LEVELS, WITHOUT SYMPTOMS OR ECG CHANGES. THE CARDIAC ENZYMES RETURNED TO A NORMAL LEVEL AFTER FOUR DAYS, WITHOUT ANY TREATMENT. AN ECHOCARDIOGRAM IN DEC 2006, REPORTED AN EJECTION FRACTION OF 50%-52%, DIASTOLIC DYSFUNCTION, AND MILD HYPOKINESIS OF THE ANTERIOR SEPTUM AND THE ANTERIOR WALL CONSISTENT WITH CORONARY ARTERY DISEASE. NO ADDITIONAL INFO 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 6071852

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O RX ACCULINK| RX ACCUNET