BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 18148564 · Received November 16, 2023

    Report

    Report Number
    2135147-2023-05048
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED MIGRATION OF PARTIAL CLIP MOVEMENT AND DIFFICULTY GRASPING APPEAR TO BE RELATED TO PATIENT MORPHOLOGY/PATHOLOGY (RESTRICTIVE POSTERIOR MITRAL LEAFLET). THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), A JET THAT SPANS THE ENTIRE COMMISSURE, EJECTION FRACTION OF 30 PERCENT, CARDIAC RESYNCHRONIZATION THERAPY WITH A PACEMAKER AND AN ICD (CRT-D), A POSTERIOR MITRAL LEAFLET (PML) MEASURED AT 11 MM, AND PML RESTRICTION. DURING A MITRACLIP PROCEDURE, THE FIRST CLIP (XTW) IS IMPLANTED CENTRO-MEDIALLY. THERE IS A RESIDUAL JET CENTRALLY AND LATERALLY. THE GRADIENT IS 3 MMHG. AN XT IS USED AS THE SECOND CLIP AND SHOULD BE IMPLANTED CENTRALLY. THE PML APPEARS RESTRICTIVE AT THIS POINT, AND IT WAS COMMUNICATED THAT THE XT COULD POSSIBLY HAVE TRACTION ON THE PML. THE PHYSICIAN CHOSE THE XT. GRASPING WAS ATTEMPTED SEVERAL TIMES, BUT EACH TIME THE PML WAS NOT GRASPED WELL. THE CLIP WAS MINIMALLY RELOCATED, CENTRO-LATERALLY. IN THIS POSITION THE LEAFLETS COULD BE EASILY GRASPED. THE MR WAS REDUCED. THE GRADIENT WAS 6MMHG. THE PHYSICIAN WAS SATISFIED WITH THE ELEVATED GRADIENT AND DECIDED TO DEPLOY. AFTER DETACHMENT, THE MR INCREASED AGAIN MEDIALLY ON THE XT. THE PML PARTIALLY WORKED ITS WAY OUT. APPROXIMATELY 5MM OF THE PML REMAINS ATTACHED TO THE XT. PER THE PHYSICIAN, THE PARTIAL DETACHMENT WAS DUE T A RESTRICTIVE PML. THE CLIP IS STABLE. THE GRADIENT IS 5MMHG. THE MR WAS REDUCED TO GRADE 2-3. RE-EVALUATION WILL TAKE PLACE IN 4-6 WEEKS. THERE WERE NO ADVERSE PATIENT SEQUELAE OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193858 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30508R1048

    Patients

    Seq Age Sex Outcome Treatment
    1 Male