BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 20278713 · Received September 23, 2024

    Report

    Report Number
    2135147-2024-04664
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) AND COMPLAINT HISTORY REVIEWS WERE NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, CAUSES FOR THE REPORTED MITRAL VALVE REGURGITATION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED PATIENT EFFECT OF MITRAL VALVE REGURGITATION, AS LISTED IN THE TRICLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH TRICLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B3: DATE OF EVENT ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. LITERATURE ATTACHMENT: ARTICLE TITLE ¿MITRAL REGURGITATION EVOLUTION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS-A SUB-ANALYSIS OF THE TRICVALVE REGISTRY."

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT BETWEEN 2010 AND 2023, 289 PATIENTS UNDERWENT A MITRACLIP OR TRICLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR). THE STUDY WAS PERFORMED TO ASSESS THE EVOLUTION OF MR AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS (TTVI) AND TO IDENTIFY PREDICTORS OF MITRAL REGURGITATION (MR) WORSENING AND IMPROVEMENT. THE MITRACLIP AND/OR TRICLIP MAY HAVE CAUSED OR CONTRIBUTED TO RECURRENT MR. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿MITRAL REGURGITATION EVOLUTION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS-A SUB-ANALYSIS OF THE TRICVALVE REGISTRY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487678 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other