BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 17719838 · Received September 11, 2023

    Report

    Report Number
    2135147-2023-03913
    Event Type
    Death
    Date Received
    September 11, 2023
    Date of Event
    October 1, 2011
    Report Date
    September 11, 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

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED DEATH AND CARDIOVASCULAR DEATH ARE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DEATH IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), AS A KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION, UNEXPECTED MEDICAL INTERVENTION, AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B2, B3, D6: DATES ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THIS WILL BE FILED TO REPORT PATIENT DEATH. THIS RESEARCH ARTICLE IS A RETROSPECTIVE STUDY DESIGNED TO EVALUATE THE IMPACT OF TREATMENT REGIMENS FOR CONCOMITANT ATRIAL FIBRILLATION (AF) ON SURVIVAL OF TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) PATIENTS. COMPLICATIONS IDENTIFIED IN THE STUDY INCLUDED WERE DEATH. IN CONCLUSION CATHETER ABLATION OF AF IS SUPERIOR TO PHARMACOTHERAPY AS IT SIGNIFICANTLY IMPROVES THE SURVIVAL OF TEER PATIENTS IN A PSM ANALYSIS. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿CATHETER ABLATION OF CONCOMITANT ATRIAL FIBRILLATION IMPROVES SURVIVAL OF PATIENTS UNDERGOING TRANSCATHETER EDGE-TO-EDGE MITRAL VALVE REPAIR¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097065 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death