BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS JR INTRALUMINAL SUPPORT

    MDR report key: 4336609 · Received December 15, 2014

    Report

    Report Number
    2032493-2014-00102
    Event Type
    Death
    Date Received
    December 15, 2014
    Date of Event
    November 17, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THE STENT REMAINS WITHIN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RIGHT MCA ANEURYSM MEASURING APPROXIMATELY 3.8CM THAT PARTIALLY THROMBOSED ON (B)(6) 2014. IT WAS REPORTED THAT THE LVIS JR. STENT WAS DEPLOYED ACROSS THE NECK AND THE ANEURYSM WAS EMBOLIZED WITH 5 ADDITIONAL COILS. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED SMALL GROIN HEMATOMA THAT CONTINUED TO WIDEN AND THEN BECAME LETHARGIC AND CONFUSED ON (B)(6) 2014. CT SCAN OF ABDOMINAL REVEALED RETROPERITONEAL BLEED, CT SCAN OF BRAIN SHOWED DIFFUSE SUBARACHNOID HEMORRHAGE AND CEREBRAL EDEMA. SUBSEQUENTLY, THE PATIENT CONDITION DETERIORATED AND REQUIRED INTUBATION. ON (B)(6) 2014, THE PATIENT WAS PRONOUNCED BRAIN DEAD AND THE FAMILY ELECTED TO WITHDRAW LIFE SUPPORT. CONSEQUENTLY, THE PATIENT EXPIRED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820619 LVIS JR INTRALUMINAL SUPPORT STENT NJE MICROVENTION, INC. 172516-LVIS JR 14061930M

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death CODMAN DELTAPLUSH COIL 2X3CM| NORMAL SALINE IV 70CC/HOUR| HEPARIN INFUSION 500 UNITS/HOUR AFTER PROCEDURE.| 2 MICROVENTION HYPERSOFT 3D COILS MEASURING 2X3CM| ASA 81MG PO DAILY| MORPHINE IV 2MG FOR SEVERE PAIN PRN| COILS IMPLANTED DURING PROCEDURE| CODMAN CAHSMERE COIL 10X25CM| PLAVIX 75MG PO DAILY| (B)(6) 2014 STOPPED AT 01:36AM. STARTED ON| INSERTION SITE.| STARCLOSE SE DEPLOYED POST-RUPTURE RIGHT GROIN