BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1833429 · Received August 30, 2010

    Report

    Report Number
    9616695-2010-00037
    Event Type
    Death
    Date Received
    August 30, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF CEREBROVASCULAR ACCIDENT (STROKE), NEUROLOGICAL DEFICIT/DYSFUNCTION, THROMBOSIS, HEMORRHAGE, AND DEATH ARE KNOWN ADVERSE EVENT LISTED IN THE XACT INSTRUCTIONS FOR USE (IFU). IN THIS CASE, THE PT WAS TREATED WITH ADDITIONAL THERAPY/NON-SURGICAL TREATMENT AND MEDICATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. THE EMBOSHIELD NAV 6 (22438-19, 9073151), INDICATED IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): IN-STENT THROMBUS, HYPERPERFUSION SYNDROME, INTRACRANIAL BLEED, DEATH. TIME OF AE: POST PROCEDURE. IT WAS REPORTED VIA TRIAL THAT DURING THE PROCEDURE, AN XACT STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY ON (B)(6)2010. DURING FILTER RETRIEVAL, THERE WAS DIFFICULTY ADVANCING THE EMBOSHIELD NAV 6 RETRIEVAL CATHETER (RC) THROUGH THE STENT. A STIFF BUDDY WIRE WAS INSERTED AND THE RC WAS ADVANCED WITHOUT DIFFICULTY AND THE FILTER WAS SUCCESSFULLY RETRIEVED. POST PROCEDURE THE PT DEVELOPED RIGHT UPPER EXTREMITY PLEGIA, RIGHT LOWER EXTREMITY PARESIS, AND APHASIA. REPEAT ANGIOGRAM SHOWED IN-STENT THROMBUS. CT SCAN OF THE HEAD SHOWED NO ACUTE PROCESS. INTRA-ARTERIAL REOPRO AND ORAL PLAVIX WERE GIVEN WITH NEAR COMPLETE RESOLUTION OF THROMBUS. TWO HOURS LATER, THE PT EXPERIENCED HYPERPERFUSION SYNDROME WITH LETHARGY AND DECREASED LEVEL OF CONSCIOUSNESS. CT SCAN OF THE HEAD SHOWED LEFT FRONTAL LOBE INTRAPARENCHYMAL HEMORRHAGE WITH ASSOCIATED PERIHEMATOMA EDEMA AND 7MM LEFT/RIGHT MIDLINE SHIFT. THE PT WAS EMERGENTLY SEDATED AND INTUBATED FOR AIRWAY PROTECTION. REPEAT CT SCAN OF THE HEAD SHOWED INCREASED SIZE OF LEFT FRONTAL BLEED AND INCREASED MIDLINE SHIFT. THE PT WAS EXTUBATED ON (B)(6)2010, PLACED IN HOSPICE CARE, AND DIED ON (B)(6)2010. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 541966

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death EMBOLIC PROTECTION: EMBOSHIELD NAV 6| GUIDE WIRE: AMPLATZ| (22438-19, (B)(4))