BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 23621503 · Received November 21, 2025

    Report

    Report Number
    2135147-2025-06821
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    June 1, 2016
    Report Date
    November 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 ATRIAL FIBRILLATION, LUNG DISEASE, PREVIOUS PERCUTANEOUS CORONARY INTERVENTION. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE ARTICLE "ADAPTATION OF RIGHT VENTRICULAR FUNCTION FOLLOWING TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY, TO EVALUATE CHARACTERIZING CHANGES IN RV EJECTION FRACTION (RVEF) FOLLOWING T-TEER AND THEIR PROGNOSTIC IMPLICATIONS. DEVICES MENTIONED INCLUDE MITRACLIP, TRICLIP, AND NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT RV RESPONSE TO T-TEER IS HETEROGENEOUS, MOSTLY INFLUENCED BY BASELINE RV FUNCTION, RV-PA COUPLING AND TR PROGRESSION. ONLY A MINORITY OF PATIENTS EXHIBITED AN INCREASE IN RVEF POST T-TEER, AND THESE PATIENTS SHOWED WORSENING TR AND A POORER PROGNOSIS. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS PHILIPP LURZ AT DEPARTMENT OF CARDIOLOGY, UNIVERSITY MEDICAL CENTER OF THE JOHANNES GUTENBERG-UNIVERSITY MAINZ, MAINZ, GERMANY WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS JUNE 2016 TO JULY 2022. A TOTAL OF 69 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 ATRIAL FIBRILLATION, LUNG DISEASE, PREVIOUS PERCUTANEOUS CORONARY INTERVENTION. (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
    2463567 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL UNKNOWN TCDS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death