BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB SL

    MDR report key: 12609584 · Received October 11, 2021

    Report

    Report Number
    2032493-2021-00404
    Event Type
    Death
    Date Received
    October 11, 2021
    Date of Event
    September 12, 2021
    Report Date
    September 12, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429110898
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCE'S ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE REMAINS IMPLANTED AND NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS. PROVIDED FLUOROSCOPIC IMAGE SHOWS WHAT APPEARS TO A WEB DEVICE IMPLANTED IN AN MCA ANEURYSM. THIS IMAGE APPEARS TO HAVE BEEN TAKEN IMMEDIATELY AFTER IMPLANTATION OF THE WEB DEVICE AND DOES NOT CONTAIN CONTENT TO CONFIRM THE COMPLAINT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ISCHEMIC STROKE, HEMORRHAGE AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEB DEVICE WAS USED FOR TREATING A RUPTURED MCA WIDE NECK ANEURYSM. THE CASE WENT VERY WELL AND PHYSICIAN WAS ABLE TO PLACE THE WEB SUCCESSFULLY ON THE FIRST ATTEMPT. DYNA CT SHOWED GOOD WALL APPOSITION AND ALL BRANCHES OPEN. FINAL ANGIOGRAPHY SHOWED SOME STAGNATION IN THE ANEURYSM, ALL VESSELS OPEN AND FILLING WELL. PATIENT WOKE UP OK AND WENT TO THE ICU TO RECOVER. REPORTEDLY, 45 MINUTES LATER THE PATIENT WAS SHOWING SIGNS OF A STROKE AND CT SHOWED A LARGE HEMORRHAGIC BLEED. AN OPEN CRANIOTOMY WAS PERFORMED TO EVACUATE THE BLOOD AND A VENTRICULOSTOMY PLACED. THE NEXT MORNING A REPEAT ANGIOGRAM SHOWED THE ANEURYSM WAS OCCLUDED AND THE PATIENT WENT BACK TO THE ICU. REPORTEDLY, THE PATIENT PASSED AWAY A DAY OR TWO LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504480 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W5-6-4-MVI-3 21030116R 00842429110898

    Patients

    Seq Age Sex Outcome Treatment
    1 Death