BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTA CLOSURE DEVICE 18FR UNK

    MDR report key: 23923391 · Received December 30, 2025

    Report

    Report Number
    MW5181459
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 22, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD TAVR PROCEDURE ON (B)(6) 2025 AND ON (B)(6) 2025 REPORTED TO EMERGENCY ROOM WITH A COLD LEG. IMAGING DISCOVERED FOOTPLATE FROM MANTA CLOSURE DEVICE HAD PREMATURELY DETACHED AND MIGRATED DOWN LEG CAUSING AN OCCLUSION IN THE POPLITEAL ARTERY THAT HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585108 MANTA CLOSURE DEVICE 18FR UNK DEVICE, HEMOSTASIS, VASCULAR MGB TELEFLEX MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization