BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 1111543 · Received August 13, 2008

    Report

    Report Number
    3004742046-2008-00194
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NFA
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENT PLACEMENT OVER INAPPROPRIATE GUIDE WIRE. THE FILTER AND A PORTION OF THE FILTER WIRE REMAIN IN THE ANATOMY. A PORTION OF THE ACCUNET WIRE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULTY REMOVING FILTER, FILTER ENTRAPMENT, FILTER WIRE SEPARATION. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: FILTER EMBEDDED IN VESSEL, PORTION OF FILTER WIRE REMAINS IN VESSEL, HYPOTENSION. IT WAS REPORTED THAT DURING A RIGHT COMMON CAROTID ARTERY STENTING PROCEDURE, THE RX ACCUNET WAS PLACED THROUGH A HEAVILY CALCIFIED LESION AND PARKED IN THE RIGHT INTERNAL CAROTID ARTERY WITHOUT ANY PROBLEMS. BECAUSE OF THE CALCIFICATION THE PHYSICIAN CHOSE TO IMPLANT AN OMNILINK STENT IN THE TARGET LESION OVER A .035 BUDDY WIRE, NOT OVER THE FILTER WIRE. THE OMNILINK STENT DELIVERY SYSTEM AND BUDDY WIRE WERE REMOVED WITHOUT DIFFICULTY, BUT THE RX ACCUNET WIRE WAS TRAPPED BETWEEN THE IMPLANTED STENT AND VESSEL WALL AND THE FILTER COULD NOT BE REMOVED. THE PHYSICIAN TRIED TO PULL OUT THE FILTER AND, IN DOING SO, THE FILTER WIRE SEPARATED INTO TWO PIECES, LEAVING AN UNKNOWN LENGTH OF WIRE IN THE PATIENT, EXTENDING FROM BEHIND THE STENT POSSIBLY TO THE ABDOMINAL AORTA. THE PHYSICIAN COLLAPSED THE FILTER AND DEPLOYED A SECOND RX ACCUNET ABOVE THE STENT TO CATCH DEBRIS, THEN IMPLANTED AN RX ACCULINK DISTAL TO THE OMNILINK TO CRUSH THE FILTER INTO THE VESSEL WALL. THE SECOND FILTER WAS REMOVED WITHOUT DIFFICULTY. THE PATIENT EXPERIENCED SOME HYPOTENSION BUT WAS NEUROLOGICALLY INTACT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NFA ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8020451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention .035 GUIDE WIRE| OMNILINK STENT