BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB 17

    MDR report key: 12844545 · Received November 19, 2021

    Report

    Report Number
    2032493-2021-00455
    Event Type
    Death
    Date Received
    November 19, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE DEVICE REMAINS IMPLANTED AND NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. PROCEDURE IMAGES WERE NOT PROVIDED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ISCHEMIC STROKE, HEMORRHAGE, DEVICE MIGRATION AND DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    THE JOURNAL ARTICLE "INTRACRANIAL ANEURYSM TREATMENT WITH INTRASACCULAR FLOW DISRUPTION: COMPARISON OF WEB-21 AND WEB 17 SYSTEMS", PUBLISHED IN PAGANO P, ET AL. J NEUROINTERVENT SURG 2021;0:1-6. DOI:10.1136/NEURINTSURG-2021-017876", RECENTLY REPORTED ON THE AUTHOR'S CLINICAL EXPERIENCE WITH WEB-17 AND WEB-21 DEVICES. IT WAS REPORTED THAT FROM JUNE 2015 TO NOVEMBER 2019, 87 PATIENTS WITH 92 ANEURYSMS WERE TREATED WITH WEB-21 (38/92, 41.3%) AND WEB-17 (54/92, 58.7%). THE MORBIMORTALITY DATA INDICATED THAT ONE PATIENT DEVELOPED HEMORRHAGE COMPLICATIONS AND EXPIRED. THE PATIENT'S TWO ANEURYSMS (RIGHT MCA AND LEFT ICA-OPHTHALMIC ANEURYSM IN ORDER OF TREATMENT) WERE TREATED WITH THE WEB-17 DEVICE THAT WAS PLACED IN THE ICA ANEURYSM, BUT THE WEB REPORTEDLY MIGRATED AFTER DETACHMENT INTO THE DISTAL CIRCULATION. THE DEVICE WAS REMOVED FROM AN M2 BRANCH USING A SOLITAIRE AND AN ASPIRATION CATHETER. POSTOPERATIVELY, THE PATIENT WORSENED CLINICALLY, AND CT REVEALED A LARGE LEFT HEMISPHERIC HEMATOMA RESULTING IN THE PATIENT'S DEATH. DATE OF DEATH IS UNKNOWN. THIS IS REPORT 1 OF 5. (REF. MFR. REPORTS #: 2032493-2021-00456, 2032493-2021-00458, 2032493-2021-00459, AND 2032493-2021-00460).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739394 WEB 17 INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death