BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB

    MDR report key: 14253130 · Received April 29, 2022

    Report

    Report Number
    2032493-2022-00179
    Event Type
    Injury
    Date Received
    April 29, 2022
    Report Date
    April 20, 2022
    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 NUMBERS WERE 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: CORTESE, JONATHAN, ET AL. "DETERMINANTS OF CEREBRAL ANEURYSM OCCLUSION AFTER EMBOLIZATION WITH THE WEB DEVICE: A SINGLE-INSTITUTION SERIES OF 215 CASES WITH ANGIOGRAPHIC FOLLOW-UP." JOURNAL OF NEUROINTERVENTIONAL SURGERY (2022).

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE JOURNAL ARTICLE TITLED, DETERMINANTS OF CEREBRAL ANEURYSM OCCLUSION AFTER EMBOLIZATION WITH THE WEB DEVICE: A SINGLE-INSTITUTION SERIES OF 215 CASES WITH ANGIOGRAPHIC FOLLOW-UP" 70 PATIENTS WITH RUPTURED AND UNRUPTURED ANEURYSMS WERE TREATED WITH A WEB DEVICE (WEB-SL QTY 32, WEB-DL QTY 4, WEB-SLS QTY 8, FIFTH-GENERATION WEB QTY 26) BETWEEN JULY 2012 AND OCTOBER 2021. ALL PATIENTS WERE OBSERVED TO HAVE DEVELOPED ANEURYSM REMNANTS DURING THE ANGIOGRAPHIC FOLLOW-UP PERIOD (3-97 MONTHS), OF WHICH 20 REQUIRED RETREATMENT BECAUSE OF THE RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109670 WEB INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R