BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    MDR report key: 15225526 · Received August 15, 2022

    Report

    Report Number
    2135147-2022-00771
    Event Type
    Death
    Date Received
    August 15, 2022
    Date of Event
    July 20, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP WAS IMPLANTED AND WILL NOT RETURN. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) REVIEW AND SIMILAR COMPLAINT REVIEW WERE NOT PERFORMED BECAUSE THE PART NUMBER AND LOT INFORMATION WERE PROVIDED. BASED ON THE INFORMATION REVIEWED, THE REPORTED DEATH WAS SUSPECTED TO BE AN ACUTE EXACERBATION OF CHRONIC HEART FAILURE (DISEASE). THE REPORTED DYSPNEA, CARDIAC ARREST, RESPIRATORY FAILURE, AND HEART FAILURE APPEARS TO BE RELATED TO CHRONIC DISEASES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION (CPR), MEDICATION REQUIRED, AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. CARDIAC ARREST, DEATH/EXPIRE, RESPIRATORY FAILURE, DYSPNEA, AND HEART FAILURE/CONGESTIVE HEART FAILURE 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 REPORT IS BEING CONSERVATIVELY FILED DUE TO CARDIAC ARREST AND PATIENT DEATH, UNKNOWN IF DEVICE RELATED. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH FUNCTIONAL, ISCHEMIC MITRAL REGURGITATION WITH LEAFLET TETHERING. MITRACLIP WAS SUCCESSFULLY IMPLANTED, WITHOUT A DEVICE ISSUE, REDUCING THE MR TO GRADE 1+. ON (B)(6) 2022, THE PATIENT EXPERIENCED WORSENING DYSPNEA AND CONTACTED EMERGENCY PERSONNEL. THE PATIENT WENT INTO CARDIO-PULMONARY ARREST. CARDIO-PULMONARY RESUSCITATION WAS PERFORMED, MEDICATIONS PROVIDED, AND THE PATIENT WAS INTUBATED, WITH A RETURN OF CIRCULATION. HOWEVER, THAT DAY, THE PATIENTS HEART RHYTHM WAS AGAIN ASYSTOLE, AND THEY EXPIRED. THE CAUSE OF DEATH WAS SUSPECTED AS AN ACUTE EXACERBATION OF CHRONIC HEART FAILURE. THE EVENT IS UNKNOWN IF RELATED TO THE MITRACLIP DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294222 MITRACLIP G4 CLIP DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 10330R101

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Death