BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1833501 · Received September 8, 2010

    Report

    Report Number
    3004742046-2010-00406
    Event Type
    Death
    Date Received
    September 8, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 16, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF NEUROLOGICAL DEFICIT/DYSFUNCTION, THROMBOSIS, HYPOTENSION, CEREBROVASCULAR ACCIDENT (STROKE) AND DEATH ARE KNOWN ADVERSE EVENTS LISTED IN THE XACT INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT (AE): POSSIBLE IN-STENT THROMBUS, TRANSIENT ISCHEMIC ATTACKS, HYPOTENSION, STROKE, DEATH. TIME OF AE: POST PROCEDURE. IT WAS REPORTED VIA TRIAL THAT 1 HOUR POST SUCCESSFUL STENT IMPLANTATION IN THE LEFT INTERNAL CAROTID ARTERY, ON (B)(6)2010, THE PATIENT EXPERIENCED HYPOTENSION TREATED WITH DOPAMINE, ORAL SUDAFED AND FLUIDS. ON (B)(6)2010, 3 DAYS POST PROCEDURE, THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA) WITH FACIAL DROOP, INCREASING CONFUSION/DISORIENTATION, SLURRED SPEECH, AND RIGHT WEAKNESS. CT SCAN OF THE HEAD SHOWED A SMALL INTRALUMINAL POSSIBLE FILLING DEFECTS ALONG THE MARGINS OF THE STENT, SUGGESTING THROMBUS, BUT SHOWED NO EVIDENCE OF STROKE. HEPARIN DRIP WAS ADMINISTERED AND A LOADING DOSE OF PLAVIX WAS GIVEN, SINCE THE PATIENT HAD NOT RECEIVED PLAVIX SINCE THE DAY OF THE PROCEDURE. THE SYMPTOMS RESOLVED WITHIN 24 HOURS. ON (B)(6)2010, THE PATIENT EXPERIENCED A REPEAT EPISODE OF THE NEUROLOGIC DEFICITS ALONG WITH THE HYPOTENSION. THE NEUROLOGICAL DEFICITS COMPLETELY RESOLVED WITHIN 24 HOURS. HYPOTENSION RESOLVED ON (B)(6)2010, AND THE PATIENT WAS DISCHARGED TO HOME ON (B)(6)2010. ON (B)(6)2010, THE PATIENT EXPERIENCED A MASSIVE STROKE WITH RIGHT SIDED DEFICITS AND DIFFICULTY SPEAKING. THE PATIENT DIED AT HOME DUE TO STROKE 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 9120251

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death HEPARIN| EMBOSHIELD NAV 6 (22438-19, LOT # 0050451),