BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB SL

    MDR report key: 11853150 · Received May 19, 2021

    Report

    Report Number
    2032493-2021-00177
    Event Type
    Death
    Date Received
    May 19, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00856956005817
    PMA / PMN Number
    K162524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES 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 WAS IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. ADDITIONALLY, PROCEDURAL IMAGES WERE NOT PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED. THE INSTRUCTIONS FOR USE IDENTIFIES DEATH AND HEMORRHAGE AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEB DEVICE WAS IMPLANTED IN A RUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY BIFURCATION ON (B)(6) 2020 WITH GOOD OCCLUSION OF THE ANEURYSM AND STAGNATE FLOW IN THE SAC. THE PATIENT WAS EVALUATED ONE MONTH POST-OP AND THE ANEURYSM DID NOT SHOW UP ON MRA. THE ANEURYSM WAS DETERMINED TO BE OCCLUDED. AT THREE MONTHS POST-OP, THE PATIENT DEVELOPED EYE PAIN. IMAGING REVEALED THE ANEURYSM HAD GROWN SIGNIFICANTLY, THE ANEURYSM APPEARED TO HAVE SIGNIFICANT FILLING IN THE NECK AND BASE OF THE ANEURYSM SAC, AND THE WEB WAS COMPACTED INTO THE DOME. THE PATIENT EXPERIENCED ACUTE SYMPTOMS WAS DIAGNOSED WITH A LARGE SUBDURAL HEMATOMA AND SUBARACHNOID HEMORRHAGE. THE PATIENT LATER PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747139 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. FGA15080-040 20030411C 00856956005817

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death