BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 19616688 · Received June 26, 2024

    Report

    Report Number
    2135147-2024-03047
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    March 1, 2021
    Report Date
    August 7, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. ATTACHMENT: ARTICLE TITLED ¿THE SAFETY OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO GUIDE TRANSCATHETER TRICUSPID VALVE EDGE-TO-EDGE REPAIR". THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED SLDA (INTRAPROCEDURE AND PERIPROCEDURE). THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: DATE OF EVENT ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. ATTACHMENT: ARTICLE TITLED ¿THE SAFETY OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO GUIDE TRANSCATHETER TRICUSPID VALVE EDGE-TO-EDGE REPAIR".

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT FROM MARCH 2021 TO FEBRUARY 2024, 53 PATIENTS UNDERWENT A TRICLIP PROCEDURE. OF THE 53 PATIENTS, FIVE EXPERIENCED A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). FOUR DURING THE PROCEDURE AND ONE PRIOR TO DISCHARGE. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿THE SAFETY OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY TO GUIDE TRANSCATHETER TRICUSPID VALVE EDGE-TO-EDGE REPAIR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672883 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female TRICLIP STEERABLE GUIDE CATHETER