BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS INTRALUMINAL SUPPORT

    MDR report key: 4527945 · Received February 13, 2015

    Report

    Report Number
    4527945
    Event Type
    Death
    Date Received
    February 13, 2015
    Date of Event
    January 11, 2015
    Report Date
    January 13, 2015
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS S/P COIL EMBOLIZATION OF A PREVIOUSLY RUPTURED FUSIFORM ANEURYSM LOCATED IN THE BASILAR ARTERY (B)(6) 2014 AND ADD'L COILING AND EMBOLIZATION (B)(6) 2015. POST PROCEDURE PT WAS MONITORED FOR COMPLICATIONS, NONE WERE PRESENT. PT WAS STABLE FOR DISCHARGE ON (B)(6)2015. ON (B)(6) 2015, TEN DAYS LATER, THE PT PRESENTED TO OUTSIDE HOSP WITH UPPER RESPIRATORY SYMPTOMS AND WHILE BEING EVALUATED EXPERIENCED GENERALIZED TONIC CLONIC SEIZURES; CT SCAN SHOWED SUBARACHNOID HEMORRHAGE. PT WAS INTUBATED AND TRANSFERRED TO HARBORVIEW MEDICAL CTR (HMC). UPON ARRIVAL AT HMC, PT WAS NOTED TO BE HEMODYNAMICALLY STABLE BUT WITHOUT BRAINSTEM REFLEXES. THE PT WAS DECLARED BRAIN DEAD AND CARE WAS WITHDRAWN ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107027 LVIS INTRALUMINAL SUPPORT STENT NJE MICROVENTION, INC. 214049-LVIS 14120447 (3 EA)

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death ASA 325 PO, QD| DILANTIN 300MG QHS| LOSARTAN 100MG QD| PLAVIX 75MG PO QD| METOPROLOL 75MG PO Q 6HRS