BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1739493 · Received June 24, 2010

    Report

    Report Number
    3004742046-2010-00279
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    March 31, 2010
    Report Date
    June 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE STENT REMAINS IN THE PT. THE DELIVERY SYSTEM WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO. THE RX VIATRAC (PART 1008197-20, 0030451), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: STROKE, HYPOTENSION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING POST DILATATION OF THE XACT STENT IN THE LEFT INTERNAL CAROTID ARTERY USING A VIATRAC BALLOON AT 8 ATMOSPHERES FOR SIX SECONDS, THE PT EXPERIENCED A LEFT HEMISPHERIC TRANSIENT ISCHEMIC ATTACK WITH INCREASED SLURRED SPEECH AND MENTAL STATUS CHANGED THAT RESOLVED WITH HEPARIN, A NON-ABBOTT DEVICE TO ASPIRATE DEBRIS, AND NITROGLYCERIN. THE PT'S SYMPTOMS LATER RETURNED WITH CONFUSION, COMBATIVENESS, AND RIGHT SIDED WEAKNESS. THE PT WAS PRESUMED TO HAVE DEVELOPED A CEREBROVASCULAR ACCIDENT ALTHOUGH CT SCAN OF THE BRAIN DID NOT SHOW ANY ACUTE FINDINGS. THE PT HAS A HISTORY OF HYPOTENSION; HOWEVER, DOPAMINE WAS STARTED AFTER THE NAV6 FILTER WAS REMOVED FROM THE PT AT THE END OF THE PROCEDURE. THE PT CONTINUED ON DOPAMINE UNTIL DISCHARGE HOME 13 DAYS AFTER THE CAROTID PROCEDURE WITH PHYSICAL THERAPY. THE PT'S NEUROLOGICAL STATUS HAD RETURNED TO BASELINE AT THE TIME OF DISCHARGE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 9100951

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (22438-19, LOT # 0022251)| DILATATION CATHETER: RX VIATRAC| VESSEL CLOSURE: PERCLOSE| (PART 1008197-20, 0030451)| EMBOLIC PROTECTION: EMBOSHIELD NAV 6| HEPARIN