BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 19519407 · Received June 12, 2024

    Report

    Report Number
    2135147-2024-02728
    Event Type
    Death
    Date Received
    June 12, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW, AND NO DEVICE/LOT INFORMATION WAS PROVIDED. BASED ON INFORMATION FROM THE ARTICLE, SURVIVAL RATES SIGNIFICANTLY DIFFERED BETWEEN GROUPS BASED ON RESIDUAL TRICUSPID REGURGITATION (TR) AFTER THE PROCEDURE. THEREFORE, DEATH IS A CASCADING EVENT OF THE TR. A CAUSE FOR THE TR COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DEATH AND TR, AS LISTED IN THE TRICLIP INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B2: EVENT DATE IS ESTIMATED B3: DEATH DATE IS ESTIMATED LITERATURE ATTACHMENT: ARTICLE TITLE: PROGNOSTIC IMPLICATIONS OF RESIDUAL TRICUSPID REGURGITATION GRADING AFTER TRANSCATHETER TRICUSPID VALVE REPAIR

    Description of Event or Problem · 0

    THE ARTICLE "PROGNOSTIC IMPLICATIONS OF RESIDUAL TRICUSPID REGURGITATION GRADING AFTER TRANSCATHETER TRICUSPID VALVE REPAIR" WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE MULTI-CENTER STUDY, TO EVALUATE THE IMPACT OF RESIDUAL TR SEVERITY POST¿TTV REPAIR ON SURVIVAL. DEVICES MENTIONED INCLUDE MITRACLIP AND TRICLIP. THE ARTICLE CONCLUDED THAT SURVIVAL WAS SIGNIFICANTLY LOWER IN PATIENTS WITH MODERATE TO SEVERE RESIDUAL TR COMPARED TO PATIENTS WITH MILD TO MODERATE RESIDUAL TR. [THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR WAS JULIEN DREYFUS AT DEPARTMENT OF CARDIOLOGY, CENTRE CARDIOLOGIQUE DU NORD, SAINT-DENIS, FRANCE WITH CORRESPONDING EMAIL : DREYFUSJULIEN@ YAHOO.FR. THE TIME FRAME OF THE STUDY WAS NOT REPORTED. A TOTAL OF 613 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 509 (79%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 78 YEARS. COMORBIDITIES INCLUDED PERMANENT PACEMAKER, PRIOR LEFT SIDED VALVULAR HEART DISEASE INTERVENTION, HEART FAILURE, ATRIAL FIBRILLATION, DIABETES, CHORNIC LUNG DISEASE, CORONARY ARTERY DISEASE, TRICUSPID REGURGITATION. THE MAJORITY GENDER WAS FEMALE. (B)(6): PERI AND POST PROCEDURAL COMPLICATIONS INCLUDE DEATH, UNCHANGED TR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394517 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death