BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19999080 · Received August 18, 2024

    Report

    Report Number
    2135147-2024-04027
    Event Type
    Death
    Date Received
    August 18, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ATTACHMENT: ARTICLE TITLE "IMPACT OF HEART FAILURE SEVERITY ON THE MORTALITY BENEFIT OF MITRAL TRANSCATHETER EDGE-TO-EDGE VALVE REPAIR" D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE CAUSE OF THE REPORTED DEATH AND HEART FAILURE WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECTS OF HEART FAILURE AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE "IMPACT OF HEART FAILURE SEVERITY ON THE MORTALITY BENEFIT OF MITRAL TRANSCATHETER EDGE-TO-EDGE VALVE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A PROSPECTIVE MULTICENTER STUDY, TO EVALUATE THE INTERACTION BETWEEN HEART FAILURE (HR) SEVERITY AND OPTIMAL REDUCTION OF SECONDARY MITRAL REGURGITATION (SMR) ON MORTALITY IN PATIENTS UNDERGOING TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER). DEVICES MENTIONED INCLUDE MITRACLIP. THE ARTICLE CONCLUDED THAT ADVANCED HF IS ASSOCIATED WITH POOR OUTCOME IN PATIENTS UNDERGOING M-TEER. HOWEVER, AN OPTIMAL SMR REDUCTION REDUCES THE RISK OF 2-YEAR MORTALITY REGARDLESS OF HF SEVERITY. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS MARIANNA ADAMO AT ASST SPEDALI CIVILI DI BRESCIA AND DEPARTMENT OF MEDICAL AND SURGICAL SPECIALTIES INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS 2016 TO 2020. A TOTAL OF 1656 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 984 PATIENTS HAD SECONDARY MITRAL REGURGITATION AND RECEIVED AN ABBOTT DEVICE. AS THIS EVENT IS FROM A LITERATURE REVIEW, THERE IS NO RELEVANT PATIENT INFORMATION (DATE OF BIRTH, AGE, GENDER, WEIGHT, AND MEDICAL HISTORY) TO REPORT. (B)(6), UNK MITRACLIP PERI AND POST-PROCEDURAL COMPLICATIONS INCLUDED HEART FAILURE, PROLONGED HOSPITALIZATION, DEATH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993566 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death