BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 17325674 · Received July 14, 2023

    Report

    Report Number
    2135147-2023-03029
    Event Type
    Death
    Date Received
    July 14, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 3, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. HOWEVER, NO FUNCTIONAL TESTING/ANALYSIS WAS PERFORMED, AS THERE WERE NO REPORTED ISSUES RELATED TO THE FUNCTIONALITY OF THE CDS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON AVAILABLE INFORMATION, A CAUSE FOR THE REPORTED MITRAL STENOSIS COULD NOT BE DETERMINED. THE REPORTED DEATH IS DUE TO WORSENING PATIENT CONDITION. ADDITIONALLY, MITRAL STENOSIS AND DEATH ARE LISTED IN THE IFU AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. MEDICAL INTERVENTION WAS NEEDED AND WAS THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE FIRST XTW (THE ONLY CLIP THAT WAS IMPLANTED) REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT MITRAL STENOSIS AND DEATH. IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND LIVER FAILURE. DURING A MITRACLIP PROCEDURE AN XTW (30307R1002) WAS IMPLANTED. AFTER IMPLANTATION OF THE XTW, TISSUE DAMAGE WAS NOTED AND THE MR HAD INCREASED. AN XT (21109R1049) AND ADDITIONAL XTW (30315R1031) WERE ATTEMPTED TO BE IMPLANTED, BUT THE MITRAL PRESSURE GRADIENT (MPG) WAS TOO HIGH. BOTH DEVICES WERE REMOVED. THE MPG WENT TO BASELINE AFTER UNGRASPING THE XTW (30315R1031) AND THERE WERE NO ADVERSE EFFECTS CAUSED BY THE BRIEF ELEVATION IN GRADIENT. THE MPG REMAINED AT 7MMHG AFTER UN-GRASPING THE XT. AT SOME POINT, THE PATIENT WAS CONVERTED TO SURGERY DUE TO LOW BLOOD PRESSURE AND THE RESIDUAL MR FROM THE TISSUE DAMAGE. THE MR WAS REDUCED TO GRADE 3 AFTER THE MITRACLIP PROCEDURE. ON (B)(6) 2023, THE PATIENT DIED DUE TO MULTIPLE ORGAN FAILURE. THE PATIENT'S PRE-EXISTING CONDITION, LIVER FAILURE, CONTRIBUTED TO THE DEATH. THE LEAFLET INJURY FROM THE XTW, AND ELEVATED MITRAL STENOSIS FROM THE XT WERE INDIRECTLY CORRELATED TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654684 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 21109R1049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death MITRACLIP| STEERABLE GUIDE CATHETER