BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 23144783 · Received September 25, 2025

    Report

    Report Number
    2135147-2025-05413
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    April 11, 2024
    Report Date
    September 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR REINTERVENTION - TRICUSPID VALVE EVENTS WERE REPORTED TO ABBOTT FROM THE TVT DATA EXTRACT IN THE CURRENT REPORTING PERIOD (01 JULY 2025 ¿ 30 SEPTEMBER 2025). A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MITRACLIP SYSTEM WAS USED IN AN ANATOMICAL CONTEXT FOR WHICH IT IS NOT APPROVED, REPRESENTING AN OFF-LABEL USE. CAUSALITY OF THIS ADVERSE EVENT TO THE OFF-LABEL USE COULD NOT BE DETERMINED BASED ON THE AVAILABLE DATA. HOWEVER, RISK ASSESSMENT WAS COMPLETED FOR THE REPORTED INCIDENTS 4 OUT OF 197 (2.0%) SUBJECTS EXPERIENCED REINTERVENTION - TRICUSPID VALVE. THESE ADVERSE EVENTS (REINTERVENTION - TRICUSPID VALVE) AND THEIR FREQUENCY ARE CONSISTENT WITH EXPECTATIONS FOR PATIENTS TREATED WITH THE MITRACLIP AND TRICLIP SYSTEMS WITHIN THEIR LABELED INDICATION ANATOMY AND ALIGN WITH RATES REPORTED IN OTHER CLINICAL STUDIES. DATA FROM OFF-LABEL USE ARE NOT INCLUDED, AS IT IS OUTSIDE THE APPROVED INDICATION. NO NEW RISKS HAVE BEEN IDENTIFIED FOR THIS POPULATION. NO NEW HAZARDS OR HARMS WERE IDENTIFIED THAT WOULD IMPACT THE BENEFIT/RISK PROFILE. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME. D4. PRIMARY UDI NUMBER: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. D6A: IMPLANT DATE: THE EARLIEST IMPLANT DATE WAS USED. THIS REPORT IS FOR QUARTER 3 TIMEFRAME BETWEEN 01 JULY 2025 ¿ 30 SEPTEMBER 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE STS/ACC TVT REGISTRY ¿ (TRICLIP DATA EXPORT) THAT THE MITRACLIP SYSTEM THAT WAS USED OFF-LABEL FOR TRICUSPID VALVE REPAIR. IN FOUR OF THESE CASES REINTERVENTION - TRICUSPID VALVE WERE REPORTED, WHICH ARE CONSIDERED SERIOUS INJURY. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE MITRACLIP DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. STS/ACC TVT REGISTRY ¿ (TRICLIP DATA EXPORT) IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2015009. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 11 APRIL 2024 - 25 JULY 2024. PATIENTS¿ MEAN AGE IS 78 YEARS, RANGING FROM 69 - 85 YEARS. 50% OF THE PATIENTS WERE MALE, 50% OF THE PATIENTS WERE FEMALE. THE SUBMISSION TIMEFRAME IS 01 JULY 2025 ¿ 30 SEPTEMBER 2025. AS OF 27 MARCH 2025, A TOTAL OF 197 PATIENTS HAD BEEN TREATED WITH THE MITRACLIP DEVICE FOR TRICUSPID VALVE REPAIR, AS REPORTED IN THE STS/ACC TVT REGISTRY ¿ TRICLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597229 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention