BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPERSOFT 3D-AV

    MDR report key: 21702181 · Received March 26, 2025

    Report

    Report Number
    2032493-2025-90005
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 9, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    PMA / PMN Number
    K131948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT STATUS, AND CORRECTED MODEL NUMBER WERE PROVIDED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS REPORTED UNAVAILABLE FOR ANALYSIS AS IT REMAINS WITHIN THE PATIENT; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR THE FOLLOWING: THE PATIENT STATUS WAS REPORTED AS, DOING FINE. MODEL NUMBER PROVIDED IN SECTION D4.

    Description of Event or Problem · 0

    AS REPORTED, THIS WAS AN ACOMM ANEURYSM WITH A Y-STENT USING 2 STRYKER ATLAS STENTS. THIS WAS THE 4TH COIL BEING PLACED. THE COIL WENT HALFWAY INTO THE ANEURYSM THEN IT WOULD NOT ADVANCE OR PULL BACK INTO THE CATHETER. THE COIL THEN BECAME STRETCHED OUT AND IT WAS DETACHED WITH A TAIL GOING INTO THE A1 SEGMENT. PHYSICIAN TACKED DOWN WITH ANOTHER ATLAS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645955 HYPERSOFT 3D-AV DEVICE NEUROVASCULAR EMBOLIZATION HCG MICROVENTION, INC. 8410-0256-A2 0000393755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention HEADWAY DUO