BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVALVE TRANSEPTAL DELIVERY SYSTEM FOR TMVR TRANSCATHETER MITRAL VALVE REPLACE

    MDR report key: 23693365 · Received December 2, 2025

    Report

    Report Number
    MW5179695
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 20, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INNOVALVE BIOMEDICAL LTD. / EDWARDS LIFESCIENCES LLC
    Product Code
    NPU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD ELECTIVE TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) TWIST TRIAL FOR RESEARCH STUDY VIA RIGHT FEMORAL ACCESS SITE. MEDICAL HISTORY CORONARY ARTERY DISEASE, DIABETES, SEVERE MITRAL VALVE REGURGITATION. POST PROCEDURE THE CAPSULE OF THE DELIVERY SYSTEM BROKE FROM THE ATTACHING SYSTEM AND WAS LOCKED INTO THE FEMORAL VEIN. VASCULAR SURGERY WAS CONSULTED AND A SURGICAL CUTDOWN OF THE RIGHT FEMORAL VEIN WAS PERFORMED TO EXTRACT THE REMAINING CAPSULE OF THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854738 INNOVALVE TRANSEPTAL DELIVERY SYSTEM FOR TMVR TRANSCATHETER MITRAL VALVE REPLACE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU INNOVALVE BIOMEDICAL LTD. / EDWARDS LIFESCIENCES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention