BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1844672 · Received September 23, 2010

    Report

    Report Number
    3004742046-2010-00436
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. INTRACRANIAL HEMORRHAGE AND NEUROLOGICAL DEFICIT/DYSFUNCTION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CAROTID STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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

    IT WAS REPORTED VIA A TRIAL THAT ONE DAY POST SUCCESSFUL STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY THE PT EXPERIENCED ISOLATED LEFT FACIAL DROOP. POST PROCEDURE REVIEW OF CEREBRAL CIRCULATION SHOWED A 5MM ARTERIOVENOUS MALFORMATION (AVM). CT SCAN AND MRI SHOWED LEFT PARIETAL HEMATOMA AND SUBARACHNOID HEMORRHAGE IN THE LEFT TEMPORAL/PARIETAL AREA. IT WAS BELIEVED THAT THE BLEEDING WAS DUE TO REPERFUSION SYNDROME AT THE SITE OF THE AVM. PLAVIX AND ASPIRIN WERE HELD AND LABETALOL DRIP WAS ADMINISTERED TO REDUCE BLOOD PRESSURE. THE PT WAS DISCHARGED TO A REHABILITATION FACILITY ON (B)(6) 2010 AND THE EVENT WAS CONSIDERED RESOLVED. AT THE TIME OF DISCHARGE ASPIRIN WAS RESUMED AND PLAVIX CONTINUED TO BE HELD. THOUGH REQUESTED, NO ADDITIONAL INFO 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 9062651

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R| S (1011649-55, LOT 9061651)| EMBOLIC PROTECTION: RX ACCUNET| OTHER: BIVALIRUDIN