BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1040030 · Received May 7, 2008

    Report

    Report Number
    3004742046-2008-00100
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 14, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. THE LOT HISTORY RECORD WAS REVIEWED, AND THERE ARE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    STUDY EVENT. DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: ASYMPTOMATIC BRADYCARDIA. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT EXPERIENCED PERSISTENT ASYMPTOMATIC BRADYCARDIA. THE PT HAS A HISTORY OF ATRIAL FIBRILLATION AND TACHYBRADY SYNDROME, BUT WAS NOT FOLLOWED BY A CARDIOLOGIST. THE PT'S COREG WAS HELD PRIOR TO THE PROCEDURE, AS IT IS A POLICY FOR CAROTID STENTING. POST PROCEDURE, THE DIGOXIN WAS ALSO HELD. THE PT WAS EVALUATED FOR POSSIBLE PACEMAKER PLACEMENT. TWO DAYS POST PROCEDURE, SHE WAS DISCHARGED HOME WITH A HOLTER MONITOR FOR CARDIAC RHYTHM EVALUATION. A FEW DAYS AFTER DISCHARGE, THE PT CALLED THE OFFICE WITH COMPLAINTS OF PALPITATIONS. AN ECG DONE IN THE OFFICE SHOWED "ATRIAL FIBRILLATION WITH LEFT BUNDLE BRANCH BLOCK" LEFT BUNDLE BRANCH BLOCK HAD BEEN PRESENT PRIOR TO INTERVENTION). SHE WAS STARTED BACK ON HER DIGOXIN AND HER COREG DOSE WAS RETURNED TO PRE-INTERVENTION DOSE. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8030651

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RX ACCUNET| HEPARIN