BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 14864021 · Received June 29, 2022

    Report

    Report Number
    2024168-2022-07065
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 7, 2022
    Report Date
    June 29, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    UDI-DI
    08717648230967
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE UNINTENDED MOVEMENT (CLIP OPEN- ESTABLISH FINAL ARM ANGLE). THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT THE CLIP OPENED WHILE LOCKED. IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT WAS PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR), WITH A MR GRADE OF 4 AND CALCIUM ON THE MITRAL VALVE. THE NTW CLIP WAS ADVANCED TO THE LEAFLETS AND AFTER THE LOCK LINE WAS REMOVED, WHILE ESTABLISHING FINAL ARM ANGLE (EFAA), THE CLIP STARTED TO OPEN. THE NTW CLIP WAS CLOSED TIGHTLY AND EFAA WAS TESTED AGAIN. DURING THE FINAL EFAA, THE LOCK HELD AND THE NTW CLIP WAS DEPLOYED. THE NTW CLIP WAS STABLE AND ATTACHED TO BOTH LEAFLETS POST-DEPLOYMENT. THE MR WAS REDUCED TO GRADE 1-2. THERE WAS NO ADVERSE PATIENT CONSEQUENCE OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945154 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR CDS0701-NTW 11005R184 08717648230967

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STEERABLE GUIDE CATHETER