BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1700205 · Received May 25, 2010

    Report

    Report Number
    3004742046-2010-00219
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 30, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING.

    Description of Event or Problem · 1

    ADVERSE EVENT: CEREBRAL HEMORRHAGE, DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA TRIAL, THAT DURING A RIGHT COMMON CAROTID ARTERY STENTING PROCEDURE, AFTER STENT IMPLANTATION, THE PT WITH A KNOWN CEREBRAL ANEURYSM, EXPERIENCED A RAPID DECLINE INTO CARDIAC ARREST. CARDIO-PULMONARY RESUSCITATION (CPR) WITH INTUBATION WAS PERFORMED SUCCESSFULLY. CT SCAN SHOWED A LARGE HEMORRHAGE CAUSED BY A RUPTURED CEREBRAL ANEURYSM AND BRAINSTEM HERNIATION. THE PT WENT INTO CARDIAC ARREST A SECOND TIME AND WAS REMOVED FROM MECHANICAL VENTILATION RESULTING IN DEATH. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED. ADDITIONAL INFO REPORTED THAT THE EMBOSHIELD WOULD NOT CROSS THE HEAVILY TORTUOUS LESION. NO EMBOLIC PROTECTION DEVICE WAS USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0011551

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| L| R GUIDE WIRE: THRUWAY WIRE 0.14 MM 300 CM| DILATATION CATHETER: STERLING BALLOON| EMBOLIC PROTECTION: EMBOSHIELD NAV 6 22437-19| LOT 0031951| GUIDE CATH: SL 10 MACRO, OTHER HEPARIN