BEUDAMED
    FDA Adverse Event Death Summary report: N

    LVIS 4.5X23 (HDE)

    MDR report key: 7023178 · Received November 10, 2017

    Report

    Report Number
    2032493-2017-00283
    Event Type
    Death
    Date Received
    November 10, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 12, 2017
    Manufacturer
    MICROVENTION, INC.
    Product Code
    NJE
    UDI-DI
    00812636022215
    PMA / PMN Number
    K130005
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORD INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE STENT WAS IMPLANTED AND THE REMAINDER OF THE DEVICE WAS DISCARDED AT THE USER FACILITY; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE PHYSICIAN STATED THAT THE HEMORRHAGE FROM THE RUPTURE OF THE M1 ARTERY WAS NOT RELATED TO THE STENT. THE DEVICE PERFORMED AS EXPECTED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES HEMORRHAGE AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING TREATED FOR A HIGH-GRADE (90%) STENOTIC ATHEROSCLEROTIC PLAQUE IN THE LEFT MCA. AFTER THE FIRST INFLATION WITH A BALLOON (NON-MICROVENTION), THERE WAS SIGNIFICANT IMPROVEMENT OF FLOW; HOWEVER, 80% STENOSIS REMAINED. A SECOND, LARGER BALLOON (NON-MICROVENTION) WAS ADVANCED AND INFLATED AT THE SAME SITE. A POST-DILATATION ANGIOGRAM REVEALED ACTIVE CONTRAST EXTRAVASATION FROM A RUPTURED MCA. THE LVIS STENT WAS SUCCESSFULLY DEPLOYED WITHOUT COMPLICATIONS AT THE BLEEDING SITE AS TREATMENT FOR THE BLEEDING, FOLLOWED BY COIL EMBOLIZATION AND TOTAL OCCLUSION OF THE M1 ARTERIAL SEGMENT. FOLLOW-UP ANGIOGRAM DEMONSTRATED TOTAL RESOLUTION OF THE EXTRAVASATION, AND THE BALLOON AND MICROCATHETER WERE REMOVED. NO FURTHER THERAPY WAS ADMINISTERED TO THE PATIENT PER THE FAMILY'S REQUEST DUE TO THE POOR PROGNOSIS. THE CLINICAL RESEARCH NURSE REPORTED THAT THE PATIENT DIED; HOWEVER, THE DEATH WAS A RESULT OF THE PROCEDURE AND WAS NOT CAUSED BY THE LVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800912 LVIS 4.5X23 (HDE) STENT NJE MICROVENTION, INC. 213025-LVIS-D-HDE 16101922 00812636022215

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death