BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIA MICROCATHETER

    MDR report key: 12844653 · Received November 19, 2021

    Report

    Report Number
    2032493-2021-00456
    Event Type
    Death
    Date Received
    November 19, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    DQY
    PMA / PMN Number
    K150894
    Product Problem
    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 VESSEL DISSECTION OR PERFORATION 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%). OF THOSE PATIENTS TREATED WITH A WEB-21, ONE PATIENT HAD BEEN TREATED FOR AN UNRUPTURED MCA ANEURYSM. REPORTEDLY, THE DISTAL TIP OF THE VIA MICROCATHETER PERFORATED THE MCA ARTERY LEADING TO A LARGE SUBARACHNOID BLEED THAT WAS TREATED WITH BALLOONING AND MCA COILING. THE PATIENT DEVELOPED INTRAPROCEDURAL HEMORRHAGE COMPLICATIONS AND SUBSEQUENTLY DIED. DATE OF DEATH IS UNKNOWN. THIS IS REPORT 2 OF 5. (REF. MFR. REPORTS #: 2032493-2021-00455, 2032493-2021-00458, 2032493-2021-00459, AND 2032493-2021-00460).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740388 VIA MICROCATHETER PERCUTANEOUS CATHETER DQY MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| D