BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    MDR report key: 1013845 · Received March 14, 2008

    Report

    Report Number
    3004742046-2008-00061
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    September 20, 2007
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICES WERE DISCARDED. THE LOT NUMBERS WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY REVIEW FOR THESE LOTS COULD NOT BE PERFORMED. THE SECOND RX VIATRAC PLUS PERIPHERAL DILATATION CATHETER, INDICATED IN IS BEING FILED UNDER THE SAME MANUFACTURER REPORT NUMBER. THE RX ACCULINK PART INDICATED IN IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: INSTENT DISSECTION. TIME OF AE: DURING PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST LEFT CAROTID ARTERY STENT IMPLANTATION OF AN RX ACCULINK STENT, THE PATIENT DEVELOPED CRITICAL, IN-STENT RESTENOSIS, NOTED ON CAROTID DUPLEX ULTRASOUND. THE PATIENT WAS HOSPITALIZED FOR TREATMENT AND IN 2007, UNDERWENT IN-STENT 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. PATIENT EXPERIENCED A VAGAL HYPOTENSIVE EPISODE THAT WAS TREATED WITH NEOSYNEPHRINE AND ATROPINE AND RESOLVED WITHIN 48 HOURS. THE PATIENT WAS DISCHARGED TO HOME 2 DAYS POST-PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART 1008197-20 LOT UNK| RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER| HEPARIN| RX ACCULINK PART 1011344-40 LOT 6120851