BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 23622112 · Received November 21, 2025

    Report

    Report Number
    2135147-2025-06853
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    January 1, 2018
    Report Date
    November 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, CONGESTIVE HEART FAILURE, CHRONIC PULMONARY DISEASE, CHRONIC PULMONARY DISEASE, DIABETES, HYPERTENSION. COMPLICATIONS REPORTED INCLUDED DEATH, PERICARDIAL EFFUSION, CARDIAC ARREST, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, HEART BLOCK, BLEEDING, ACUTE KIDNEY INJURY; 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 "RACIAL AND ETHNIC DISPARITIES IN INPATIENT OUTCOMES OF TRICUSPID TRANSCATHETER EDGE-TO-EDGE REPAIR IN THE UNITED STATES" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI CENTER STUDY, TO EVALUATE THE BASELINE CHARACTERISTICS OF PATIENTS WHO UNDERWENT T-TEER IN THE UNITED STATES AND INVESTIGATE HOSPITAL OUTCOMES BASED ON RACE AND ETHNICITY AT A NATIONAL LEVEL. DEVICES MENTIONED INCLUDE TRICLIP. THE ARTICLE CONCLUDED THAT RACIAL AND ETHNIC DISPARITIES IN T-TEER OUTCOMES ARE EVIDENT, WITH BLACK PATIENTS EXPERIENCING HIGHER MAJOR AND OVERALL COMPLICATIONS, AND BLACK AND HISPANIC PATIENTS HAVING PROLONGED HOSPITALIZATIONS. FURTHER INVESTIGATION INTO THE SPECIFIC FACTORS AND POLICIES DRIVING THESE DISPARITIES IS CRUCIAL IN STRIVING FOR MORE EQUITABLE CARDIOVASCULAR CARE AMONG DIFFERENT RACIAL AND ETHNIC POPULATIONS. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS AMANDA NGUYEN AT DEPARTMENT OF MEDICINE, UNIVERSITY OF CALIFORNIA DAVIS MEDICAL CENTER, SACRAMENTO, CALIFORNIA WITH CORRESPONDING EMAIL [email protected]]. THE TIME FRAME OF THE STUDY WAS JANUARY 2018 TO DECEMBER 2022. A TOTAL OF 2815 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 2815 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, CONGESTIVE HEART FAILURE, CHRONIC PULMONARY DISEASE, CHRONIC PULMONARY DISEASE, DIABETES, HYPERTENSION. (B)(6), UNK TRICLIP: PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, PERICARDIAL EFFUSION, CARDIAC ARREST, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, HEART BLOCK, BLEEDING, ACUTE KIDNEY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077601 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