BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 23621906 · Received November 21, 2025

    Report

    Report Number
    2135147-2025-06835
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    October 25, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. COMPLICATIONS REPORTED INCLUDED DEATH, TRICUSPID STENOSIS, RECURRENT TR, TRICUSPID VALVE REINTERVENTION, PROLONGED HOSPITALIZATION, SINGLE LEAFLET DEVICE ATTACHMENT; 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 "TRANSCATHETER TRICUSPID VALVE REPLACEMENT AND CLEFT AFTER TRICUSPID TEER" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI CENTER STUDY, TO EVALUATE TECHNIQUES AND OUTCOMES AMONG PATIENTS WHO UNDERWENT TTVR AFTER T-TEER. DEVICES MENTIONED INCLUDE MITRACLIP AND NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT THE AUTHORS PRESENT THE LARGEST SERIES OF TTVR AFTER T-TEER WITH ELECTROSURGICAL LEAFLET MODIFICATION IN A SUBSET OF PATIENTS. AT 30 DAYS, TR SEVERITY WAS MARKEDLY REDUCED, AND SUBSTANTIAL SYMPTOM ALLEVIATION OCCURRED. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS JOHN SAXON AT ADVANCED CARDIAC VALVE CENTER, UNIVERSITY OF VIRGINIA MEDICAL CENTER, CHARLOTTESVILLE, VIRGINIA WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS NOT PROVIDED. A TOTAL OF 16 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 14 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. (B)(6), UNK TRICLIP: PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, TRICUSPID STENOSIS, RECURRENT TR, TRICUSPID VALVE REINTERVENTION, PROLONGED HOSPITALIZATION, SINGLE LEAFLET DEVICE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191914 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