BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1171277 · Received September 22, 2008

    Report

    Report Number
    3004742046-2008-00229
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 29, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE FINISHED DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. VESSEL DISSECTION MAY OCCUR DURING THIS TYPE OF PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DISSECTION. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AFTER POST DILATATION OF THE RX ACCULINK STENT AND REMOVAL AND THE RX ACCUNET, CAROTID ANGIOGRAPHY REVEALED A PROXIMAL STENT EDGE DISSECTION. A NEW RX ACCUNET FILTER WAS ADVANCED ACROSS THE PREVIOUSLY PLACED STENT AND DEPLOYED. ANOTHER RX ACCULINK WAS DEPLOYED SUCCESSFULLY AT THE PROXIMAL EDGE OF THE FIRST STENT AND THE FILTER WAS EASILY RETRIEVED. ANGIOGRAPHY RESULTS WERE GOOD REVEALING BOTH STENTS WERE WELL EXPANDED WITH NO RESIDUAL STENOSIS, DISSECTION, OR PERFORATION. THE PT WAS NEUROLOGICALLY INTACT AND HEMODYNAMICALLY STABLE AND WAS DISCHARGED HOME THE NEXT DAY. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7052151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JB1 DIAGNOSTIC GUIDE CATHETER| STIFF ANGLED GLIDEWIRE| 6 FR DESTINATION SHEATH| J WIRE| NITROGLYCERIN| HEPARIN| BMW GUIDEWIRE| TRAC X 2 DILATING CATHETER