BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 18970899 · Received March 25, 2024

    Report

    Report Number
    2135147-2024-01332
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037381
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL CDS0706-XTW DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER CN-221307.

    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 REPORTED UNINTENDED MOVEMENT OF CLIP OPEN DURING EFAA. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR) AND A ROTATED HEART FOR A MITRACLIP PROCEDURE. DURING THE DEPLOYMENT SEQUENCE, THE XTW CLIP (31026A2087) OPENED DURING ESTABLISH FINAL ARM ANGLE (EFAA) BEFORE THE LOCK LINE WAS REMOVED. THE CLIP WAS CLOSED AND HAD OPENED TO 20-30 DEGREES GOING FROM A NEUTRAL KNOB POSITION WITH THE ARM POSITIONER. TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP CONTINUE TO OPEN. THE CLIP WAS REMOVED AND A REPLACEMENT XTW CLIP (31101R1037) WAS OPENED. DURING PLACEMENT OF THE REPLACEMENT XTW CLIP THERE WAS NO IMPROVEMENT OF MR GRADE (4+ TO 4+), AND THERE WAS EVIDENCE OF LEAFLET DAMAGE AFTER USE. AN ADDITIONAL CLIP WAS PLANNED, BUT NOT USED DUE TO CONCERNS WITH THE LEAFLET INTEGRITY. SURGERY WAS CONSULTED AND IT WAS DETERMINED THAT INTERVENTION WAS NOT REQUIRED. THE STEERABLE GUIDE CATHETER (SGC) WAS REMOVED AND THE CASE WAS ABORTED. THERE WAS A DELAY, BUT IT WAS NOT CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 31026A2087 05415067037381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other STEERABLE GUIDE CATHETER.