BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1419457 · Received July 21, 2009

    Report

    Report Number
    3004742046-2009-00172
    Event Type
    Injury
    Date Received
    July 21, 2009
    Date of Event
    June 24, 2009
    Report Date
    June 26, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND RX ACCULINK STENT (PART# 1011339-30, LOT# 8081851) IS BEING FILED UNDER THE SAME MFR NUMBER. EVAL SUMMARY: ANALYSIS OF THE REPORTED EVENT REVEALED THAT IT MAY BE POSSIBLE FOR THE STENT TO JUMP IF SLACK IN THE CATHETER IS NOT REMOVED PRIOR TO DEPLOYMENT. THE RX ACCULINK INSTRUCTIONS FOR USE NOTES ON TECHNIQUES TO ENSURE INTENDED PLACEMENT: "PRIOR TO STENT DEPLOYMENT, REMOVE ALL SLACK FROM THE DELIVERY SYSTEM." AND "WHILE PRESSING DOWN THE THUMB TO AVOID ANY FORWARD MOTION, RETRACT THE HANDLE TO DEPLOY THE STENT IN THE ARTERY." A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, HYPOTENSION IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE AS LISTED IN THE RX ACCULINK INSTRUCTIONS FOR USE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL NY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT JUMPED. SYMPTOMS/AE: HYPOTENSION. TIME OF DEVICE MALFUNCTION: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, DURING DEPLOYMENT, THE RX ACCULINK STENT JUMPED DISTALLY, ONLY PARTIALLY COVERING THE LESION. A SECOND RX ACCULINK WAS DEPLOYED, OVERLAPPING THE FIRST STENT AND FULLY COVERING THE LESION. THE LESION WAS POST DILATED WITH A NON-ABBOTT BALLOON. AFTER POST DILATATION, THE PT BECAME HYPOTENSIVE AND A NEOSYNEPHRINE DRIP WAS STARTED. FOUR DAYS POST PROCEDURE, THE HYPOTENSION RESOLVED AND THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8112651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R STERLING BALLOON 5 X 20| RX ACCUNET EMBOLIC PROTECTION DEVICE| BIVALIRUDIN