BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1822491 · Received August 26, 2010

    Report

    Report Number
    3004742046-2010-00377
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OCCLUSION IS A KNOWN ADVERSE EVENT LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    ADVERSE EVENT (AE): STENT OCCLUSION. TIME OF AE: POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA TRIAL THAT ONE DAY POST SUCCESSFUL STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY (LICA), CAROTID ULTRASOUND REVEALED TOTAL OCCLUSION OF THE LICA. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS GIVEN. REPORTEDLY THE DISTAL LICA WAS BECOMING ARTERITIC AND FUNCTIONALLY OCCLUDED. IT WAS BELIEVED THAT THE CIRCLE OF WILLIS WAS PERFUSING THE BRAIN AND THE LICA WAS AN ISOBARIC POINT AND DESPITE SUCCESSFUL STENT PLACEMENT, PATENCY WAS NOT ABLE TO BE MAINTAINED. THE PATIENT WAS DISCHARGED TO HOME. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0033061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other EMBOLIC PROTECTION: RX ACCUNET (1011649-65,| HEPARIN| LOT #9121451)