BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 23325263 · Received October 17, 2025

    Report

    Report Number
    2135147-2025-05932
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    January 1, 2016
    Report Date
    November 18, 2025
    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

    IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRICLIP DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING DIABETES, ATRIAL FIBRILLATION, PRIOR STROKE, HYPERTENSION, CORONARY ARTERY DISEASE. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED OFF-LABEL USE OF THE DEVICE WAS ASSOCIATED WITH THE MITRACLIP DEVICE BEING USED ON THE TRICUSPID VALVE TO TREAT TRICUSPID REGURGITATION (TR). A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE ARTICLE "IMPACT OF AGE ON OUTCOMES AFTER TRANSCATHETER TRICUSPID VALVE EDGE-TO-EDGE REPAIR: INSIGHTS FROM EUROTR" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI CENTER STUDY, TO EVALUATE TR REDUCTION, SYMPTOMATIC OUTCOMES, AND SURVIVAL FOLLOWING T-TEER STRATIFIED BY PATIENT AGE AT INTERVENTION. DEVICES MENTIONED INCLUDE MITRACLIP, TRICLIP AND NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT T-TEER EFFECTIVELY REDUCES TR IN ELDERLY PATIENTS. IRRESPECTIVE OF AGE, PATIENTS SHOWED SYMPTOMATIC BENEFIT AND COMPARABLE TWO-YEAR SURVIVAL FREE FROM HHF. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS JÖRG HAUSLEITER AT LMU KLINIKUM INSTITUTION WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS JANUARY 2016 TO DECEMBER 2024. A TOTAL OF 2340 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. AS THIS EVENT IS FROM A LITERATURE REVIEW, THERE IS NO RELEVANT PATIENT INFORMATION (DATE OF BIRTH, AGE, GENDER, WEIGHT, AND MEDICAL HISTORY) TO REPORT. COMORBIDITIES INCLUDED DIABETES, ATRIAL FIBRILLATION, PRIOR STROKE, HYPERTENSION, CORONARY ARTERY DISEASE. (B)(6), UNK MITRACLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION. (B)(6), UNK TRICLIP PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322679 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL UNK CDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization