BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SLS

    MDR report key: 12478777 · Received September 15, 2021

    Report

    Report Number
    2032493-2021-00379
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429107140
    PMA / PMN Number
    P170032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUESRELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS IMPLANTED IN THE PATIENT AND NOT AVAILABLE FOR RETURN FOR EVALUATION. THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF NEW OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC. WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING THE DELIVERY PUSHER FROM THE WEB DURING PLACEMENT IN AN ACOMM ARTERY ANEURYSM. THE PROXIMAL END OF THE WEB DEVICE WAS INDENTED DURING REMOVAL OF THE PUSHER. A GOOSE-NECK SNARE WAS USED TO CORRECT THE WEB INDENTATION. THERE WAS NO PATIENT INJURY, WHO REPORTEDLY WAS DOING WELL POST PROCEDURE AND WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375471 WEB SLS INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W2-8-3-MVI-3 20072212P 00842429107140

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR