BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 14441355 · Received May 19, 2022

    Report

    Report Number
    2032493-2022-00204
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    May 3, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AND A LOT HISTORY TRENDING REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. ARTICLE BIBLIOGRAPH: EL NAAMANI, KAREEM, ET AL. "WOVEN ENDOBRIDGE VERSUS STENT-ASSISTED COIL EMBOLIZATION OF CEREBRAL BIFURCATION ANEURYSMS." JOURNAL OF NEUROSURGERY 1.AOP (2022): 1-8.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE ARTICLE TITLED, "WOVEN ENDOBRIDGE VERSUS STENT-ASSISTED COIL EMBOLIZATION OF CEREBRAL BIFURCATION ANEURYSMS" A RETROSPECTIVE SINGLE-CENTER STUDY WAS PERFORMED THAT COMPRISED OF 63 BIFURCATION ANEURYSMS THAT WERE TREATED ENDOVASCULARLY WITH WEB DEVICES BETWEEN 2011 AND 2019. OF THOSE 63 CASES, 1 PATIENT WITH AN UNRUPTURED ANEURYSM MEASURING (4.2MM/DOME X 2.7MM/NECK) DEVELOPED AN ASYMPTOMATIC THROMBUS FORMATION, WHICH WAS MANAGED BY AN INTRA-ARTERIAL ABCIXIMAB. THE PATIENT WAS REPORTED TO HAVE COMPLETE RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190240 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other