BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 18335407 · Received December 15, 2023

    Report

    Report Number
    2135147-2023-05532
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    December 31, 2022
    Report Date
    January 29, 2024
    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 HEART FAILURE (HF) AND TRICUSPID REGURGITATION (UNCHANGED TR & RECURRENT TR) COULD NOT BE DETERMINED. ADDITIONALLY, THE REPORTED PATIENT EFFECTS OF HEART FAILURE AND TRICUSPID REGURGITATION, ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU), AND ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THE REPORTED HOSPITALIZATION, MEDICAL INTERVENTIONS, AND SURGICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THE CAUSE OF THE REPORTED OFF-LABEL USE IS DUE TO THE USER USING MITRACLIP DEVICE ON THE TRICUSPID VALVE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B2: DATE OF EVENT IS ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT IS ESTIMATED. H6: DEVICE CODE 1494 - PATIENT SELECTION (USE IN TRICUSPID VALVE). ATTACHMENT: ARTICLE TITLED ¿APPLYING THE TRILUMINATE ELIGIBILITY CRITERIA TO REAL-WORLD PATIENTS RECEIVING TRICUSPID VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH AN ARTICLE THAT BETWEEN (B)(6) 2016 AND 12/31/2022, 962 PATIENTS UNDERWENT A MITRACLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR). THE ARTICLE INDICATED THE IMPLANTED MITRACLIP OR TRICLIP MAY HAVE CAUSED OR CONTRIBUTED TO RECURRENT TR, UNCHANGED TR, PROLONGED HOSPITALIZATION, MEDICAL INTERVENTION, SURGICAL INTERVENTION, AND HEART FAILURE. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE TITLED, ¿APPLYING THE TRILUMINATE ELIGIBILITY CRITERIA TO REAL-WORLD PATIENTS RECEIVING TRICUSPID VALVE TRANSCATHETER EDGE-TO-EDGE REPAIR¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297929 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R