BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP NTR CLIP DELIVERY SYSTEM

    MDR report key: 15366339 · Received September 6, 2022

    Report

    Report Number
    2135147-2022-01024
    Event Type
    Death
    Date Received
    September 6, 2022
    Date of Event
    August 10, 2022
    Report Date
    November 21, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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, THE REPORTED CARDIAC ARREST WAS DUE TO WORSENING PATIENT CONDITION. THE REPORTED DEATH APPEARS TO BE RELATED TO THE CARDIO-RESPIRATORY ARREST. THE REPORTED PATIENT EFFECTS OF CARDIO-RESPIRATORY ARREST AND DEATH AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION 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

    THIS IS CONSERVATIVELY FILED TO REPORT A PATIENT DEATH. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MITRACLIP PROCEDURE ON (B)(6) 2022, TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. TWO MITRACLIPS WERE SUCCESSFULLY IMPLANTED REDUCING THE FINAL MR TO A GRADE OF 1+. A FOLLOW-UP PHONE CALL WAS MADE ON (B)(6) 2022, AND THE PHYSICIAN REPORTED THAT THE PATIENT HAD TWO CARDIORESPIRATORY ARRESTS ON THE MORNING OF (B)(6) 2022. THE PATIENT WAS RESUSCITATED, BUT WITHOUT SUCCESS AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431222 MITRACLIP NTR CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL 10902R115

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death 1 IMPLANTED MITRACLIP.