BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1020364 · Received March 26, 2008

    Report

    Report Number
    3004742046-2008-00069
    Event Type
    Death
    Date Received
    March 26, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 7, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE REMAINS IN THE PT. THE STENT DELIVERY SYS WAS DISCARDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NON-CONFORMING MATERIALS REPORTS ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    CAPTURE 2 STUDY EVENT. DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: INTRACRANIAL HYPERTENSION RESULTING IN DEATH. TIME OF AE: POST PROCEDURE. IT WAS REPORTED THAT 6 DAYS POST LEFT INTERNAL CAROTID ARTERY STENT PLACEMENT, THE PT DIED DUE TO INTRACRANIAL HYPERTENSION. PRE-PROCEDURE ON (B)(6) 2008, THE PT WAS HOSPITALIZED AND INTUBATED FOR SUBARACHNOID HEMORRHAGE (SAH) DUE TO RUPTURED CEREBRAL ANEURYSM WITH SEVERE VASOSPASM AND MYOCARDIAL INFARCTION. THE ANEURYSM WAS REPAIRED ON (B)(6) 2008 BUT SEVERE VASOSPASM CONTINUED DESPITE AGGRESSIVE TREATMENT. CRITICAL CAROTID STENOSIS WAS ALSO FOUND AND AS A SALVAGE ATTEMPT TO INCREASE CEREBRAL PERFUSION AN ACCULINK STENT WAS UNEVENTFULLY IMPLANTED ON (B)(6) 2008. AFTER INITIAL IMPROVEMENT HER CONDITION DETERIORATED ON (B)(6) 2008 DUE TO CEREBRAL EDEMA AND INCREASED INTRACRANIAL HYPERTENSION (ICH). AGGRESSIVE CARE WAS WITHDRAWN DUE TO A POOR PROGNOSIS AND THE PT DIED ON (B)(6) 2008. ACCORDING TO THE INVESTIGATOR, THERE IS NO DIRECT CORRELATION WITH THE DEVICE AND PT'S DECLINE AND DEATH. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 7020651

    Patients

    Seq Age Sex Outcome Treatment
    1 Death