BEUDAMED
    FDA Adverse Event Other Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1016391 · Received March 14, 2008

    Report

    Report Number
    3004742046-2008-00060
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    September 18, 2007
    Report Date
    February 19, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE 2 RX VIATRAC PLUS PERIPHERAL DILATATION CATHETERS INDICATED ARE FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF AE: APPROX 7 MONTHS POST PROCEDURE. IT WAS REPORTED THAT APPROX 7 MONTHS POST LEFT COMMON CAROTID ARTERY STENT IMPLANTATION OF AN RX ACCULINK STENT, THE PT DEVELOPED CRITICAL, IN-STENT RESTENOSIS, NOTED ON CAROTID DUPLEX ULTRASOUND. THE PT WAS HOSPITALIZED FOR TREATMENT AND IN 2007, UNDERWENT INSTENT PRE-DILATATION USING 2 VIATRAC BALLOONS. AN INTRA-STENT DISSECTION OCCURRED POST BALLOON INFLATION, AND AN XACT STENT WAS PLACED IN THE RX ACCULINK STENT TO TREAT BOTH THE DISSECTION AND THE RESTENOSIS. THERE WAS NO RESIDUAL STENOSIS. THE PT EXPERIENCED A VAGAL HYPOTENSIVE EPISODE THAT WAS TREATED WITH NEOSYNEPHRINE AND ATROPINE AND RESOLVED WITHIN 48 HOURS. THE PT WAS DISCHARGED HOME 2 DAYS POST-PROCEDURE. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADDITION 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 6120851

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RX VIATRAC PLUS PERIPHERAL DILATATION CATHETER| LOT# UNK| RX VIATRAC PLUS PERIPHERAL DILATATION CATHETER| HEPARIN| LOT# UNK