BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 23158131 · Received September 26, 2025

    Report

    Report Number
    2135147-2025-05471
    Event Type
    Death
    Date Received
    September 26, 2025
    Date of Event
    June 1, 2020
    Report Date
    October 27, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRICLIP PROCEDURE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES, ATRIAL FIBRILLATION, STROKE. COMPLICATIONS REPORTED INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION, TISSUE DAMAGE, CARDIAC TAMPONADE, SURGICAL INTERVENTION, BLEEDING, RECURRENT TR, ADDITIONAL TRICLIP PROCEDURE, ENDOCARDITIS, MIGRATION, 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.

    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.

    Description of Event or Problem · 0

    THE ARTICLE "T-TEER FOR TRICUSPID VALVE REGURGITATION: A SEX-BASED REAL-WORLD ANALYSIS FROM THE TRI-SPA REGISTRY" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI CENTER STUDY, TO EVALUATE THE IMPACT OF SEX-RELATED DIFFERENCES ON CLINICAL OUTCOMES AFTER TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER) FOR SEVERE TRICUSPID REGURGITATION (TR). DEVICES MENTIONED INCLUDE MITRACLIP, TRICLIP, AND A NON-ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT IN A REAL-WORLD SETTING T-TEER WAS EQUALLY SAFE AND EFFECTIVE IN BOTH SEXES, ACHIEVING COMPARABLE PROCEDURAL SUCCESS AND DURABLE TR REDUCTION. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS (B)(6). THE TIME FRAME OF THE STUDY WAS JUNE 2020 TO MAY 2023. A TOTAL OF 310 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 247 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 HYPERTENSION, DIABETES, ATRIAL FIBRILLATION, STROKE. (B)(6), UNK MITRACLIP: PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION, TISSUE DAMAGE, CARDIAC TAMPONADE, SURGICAL INTERVENTION, BLEEDING, RECURRENT TR, ADDITIONAL TRICLIP PROCEDURE, ENDOCARDITIS, MIGRATION, SINGLE LEAFLET DEVICE ATTACHMENT. CN-318927, UNK TRICLIP: PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, HEART FAILURE, PROLONGED HOSPITALIZATION, TISSUE DAMAGE, CARDIAC TAMPONADE, SURGICAL INTERVENTION, BLEEDING, RECURRENT TR, ADDITIONAL TRICLIP PROCEDURE, ENDOCARDITIS, MIGRATION, SINGLE LEAFLET DEVICE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123777 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