BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 16867684 · Received May 4, 2023

    Report

    Report Number
    2135147-2023-01925
    Event Type
    Death
    Date Received
    May 4, 2023
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. A2: MEAN AGE. A3: MAJORITY GENDER. B2: DATE OF DEATH WAS ESTIMATED AS (B)(6) 2008, AS THE STUDY ANALYZED PATIENTS WHO UNDERWENT M-TEER BETWEEN BETWEEN 2008 AND 2019. B3: DATE OF EVENT WAS ESTIMATED AS (B)(6) 2008, AS THE STUDY ANALYZED PATIENTS WHO UNDERWENT M-TEER BETWEEN BETWEEN 2008 AND 2019. B5: THE SERIOUS INJURIES (RECURRENT MR AND HEART FAILURE) REPORTED IN B5 ARE FILED UNDER A SEPARATE MEDWATCH REPORT. D4: THE UDI IS UNKNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED D6A: DATE OF IMPLANT WAS ESTIMATED AS (B)(6) 2008, AS THE STUDY ANALYZED PATIENTS WHO UNDERWENT MITRAL-TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER) BETWEEN BETWEEN 2008 AND 2019.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART/LOT INFORMATION WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE AND THE ARTICLE COVERING MULTIPLE PATIENTS, A CAUSE FOR THE REPORTED HEART FAILURE, MITRAL VALVE INSUFFICIENCY/REGURGITATION (RECURRENT AND UNCHANGED), CARDIO-HEPATIC SYNDROME (APPROPRIATE HEALTH IMPACT TERM/CODE NOT AVAILABLE) AND DEATH CANNOT BE DETERMINED. HOWEVER, MITRAL REGURGITATION, HEART FAILURE AND DEATH ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. 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 DEATH. THE OBJECTIVES OF THIS RETROSPECTIVE MULTICENTRIC STUDY WERE TO CHARACTERIZE THE PATTERN OF HEPATIC IMPAIRMENT, TO INVESTIGATE THE PROGNOSTIC VALUE OF CARDIO-HEPATIC SYNDROME (CHS), AND TO EVALUATE THE CHANGES IN HEPATIC FUNCTION AFTER TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER). AMONG PATIENTS WITH NORMAL PREPROCEDURAL HEPATIC FUNCTION, 9.0% SUFFERED FROM CHS AT FOLLOW-UP EXAMINATION (POST-M-TEER). DE-NOVO CHS AFTER M-TEER MIGHT BE AN INDICATOR FOR PROGRESSING HEART FAILURE AND RETROSPECTIVELY IDENTIFIES PATIENTS WHO PROFIT LESS FROM M-TEER TREATMENT. IN THE CASE OF PERSISTING MR, GREATER OR EQUAL TO GRADE 3+ AFTER INTERVENTION, NO IMPROVEMENT IN HEPATIC FUNCTION WAS OBSERVED. ADDITIONALLY, LONG-TERM DEVELOPMENT OF MR WAS A SECONDARY ENDPOINT IN THIS STUDY. THE MAIN FINDINGS OF THIS STUDY WERE THAT PRIMARY MITRAL REGURGITATION (PMR) CHOLESTATIC TYPE II CHS WAS INDEPENDENTLY ASSOCIATED WITH TWO-YEAR MORTALITY, ISCHEMIC CHS TYPE I WAS AN INDEPENDENT MORTALITY PREDICTOR IN SECONDARY MITRAL REGURGITATION (SMR) PATIENTS, AND SUCCESSFUL M-TEER MAY HAVE BENEFICIAL EFFECTS ON CHS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, CARDIO-HEPATIC SYNDROME IN PATIENTS UNDERGOING TRANSCATHETER MITRAL VALVE EDGE-TO-EDGE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532775 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death