BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 25250163 · Received May 21, 2026

    Report

    Report Number
    2135147-2026-03482
    Event Type
    Death
    Date Received
    May 21, 2026
    Date of Event
    January 1, 2016
    Report Date
    May 21, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRICLIP DELIVERY SYSTEM WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DYSLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES MELLITUS, ATRIAL FIBRILLATION, HEART FAILURE, AND CORONARY ARTERY DISEASE. COMPLICATIONS REPORTED INCLUDED TRICUSPID REGURGITATION, HOSPITALIZATION/PROLONGED HOSPITALIZATION, DEATH; 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. LITERATURE ATTACHMENT: COMBINED TRANSCATHETER MITRAL AND TRICUSPID EDGE-TO-EDGE REPAIR OR TRICUSPID EDGE-TO-EDGE REPAIR ALONE IN MODERATE MITRAL REGURGITATION: A PROPENSITY-MATCHED ANALYSIS. B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "COMBINED TRANSCATHETER MITRAL AND TRICUSPID EDGE-TO-EDGE REPAIR OR TRICUSPID EDGE-TO-EDGE REPAIR ALONE IN MODERATE MITRAL REGURGITATION: A PROPENSITY-MATCHED ANALYSIS", WAS REVIEWED. THIS RESEARCH ARTICLE PRESENTED A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE FUNCTIONAL AND PROGNOSTIC IMPACT OF MODERATE MITRAL REGURGITATION (MR) AND TO EXPLORE WHETHER CONCOMITANT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR (M-TEER) MODIFIED PROGNOSIS. THE DEVICES INCLUDED IN THE STUDY WERE PASCAL AND TRICLIP. THE ARTICLE CONCLUDED THAT MODERATE MR IS ASSOCIATED WITH WORSE CLINICAL OUTCOMES IN PATIENTS WITH SEVERE TRICUSPID REGURGITATION (TR) UNDERGOING T-TEER. CONCOMITANT M-TEER IN PATIENTS WITH MR GRADE 2+ OR 3+ WAS ASSOCIATED WITH IMPROVED SURVIVAL, SYMPTOMATIC RELIEF, AND FUNCTIONAL CAPACITY COMPARED WITH T-TEER ALONE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MOHAMMAD KASSAR, DEPARTMENT OF CARDIOLOGY, INSELSPITAL, BERN UNIVERSITY HOSPITAL, UNIVERSITY OF BERN, FREIBURGSTRASSE 18, 3010 BERN, SWITZERLAND, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WITH SEVERE TR TREATED WITH T-TEER FROM 01 JANUARY 2016 TO 31 DECEMBER 2025. A TOTAL OF 434 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE NON-CONCOMITANT M-TEER GROUP WAS 79.7 YEARS. THE AVERAGE AGE OF THE CONCOMITANT M-TEER GROUP WAS 79.6 YEARS. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DYSLIPIDEMIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DIABETES MELLITUS, ATRIAL FIBRILLATION, HEART FAILURE, AND CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396777 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