BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP DELIVERY SYSTEM (TCDS)

    MDR report key: 19617013 · Received June 26, 2024

    Report

    Report Number
    2135147-2024-03046
    Event Type
    Injury
    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
    Adverse Event
    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 FISTULA. FISTULA IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH THE TRICLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE SPECIFIC CIRCUMSTANCE AS MANUAL COMPRESSION WAS PROVIDED FOR THE FISTULA. 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. 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, ONE PATIENT ALSO EXPERIENCED AN ARTERIOVENOUS FISTULA, WHICH WAS TREATED USING MANUAL COMPRESSION. 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
    702716 TRICLIP DELIVERY SYSTEM (TCDS) TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

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