BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 19616392 · Received June 26, 2024

    Report

    Report Number
    2135147-2024-03043
    Event Type
    Death
    Date Received
    June 26, 2024
    Date of Event
    March 5, 2022
    Report Date
    July 23, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) COULD NOT BE DETERMINED. THE REPORTED RECURRENT TRICUSPID REGURGITATION (TR) WAS DUE TO THE SLDA. THE REPORTED DYSPNEA, HYPOTENSION, AND HEART FAILURE WERE DUE TO TRICUSPID REGURGITATION. THE REPORTED DEATH WAS A CASCADING EVENT OF THE REPORTED HEART FAILURE. THE CAUSE OF THE REPORTED PLEURAL EFFUSION, PULMONARY EDEMA, AND PERIPHERAL EDEMA WERE UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DEATH, DYSPNEA, HYPOTENSION, HEART FAILURE, TRICUSPID REGURGITATION, AND EDEMA, AS LISTED IN THE TRICLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THE REPORTED HOSPITALIZATION, UNEXPECTED MEDICAL INTERVENTION, AND MEDICATION REQUIRED WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED DUE TO A SINGLE LEAFLET DEVICE ATTACHMENT, RECURRENT REGURGITATION, WORSENING HEART FAILURE, AND SUBSEQUENT DEATH. CRD_1009 - AMJ-504 JAPAN. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH FUNCTIONAL TRICUSPID REGURGITATION (TR) GRADE 4, WITH A HORIZONTAL HEART, MYXOMATOUS LEAFLETS, PROLAPSE, AND QUADRICUSPID (2 POSTERIOR LEAFLETS) ANATOMY. TWO XTW TRICLIPS WERE SUCCESSFULLY DELIVERED AND DEPLOYED, REDUCING THE TR TO MILD, GRADE 1. ON (B)(6) 2022, THE DISCHARGE ECHOCARDIOGRAM WAS PERFORMED. TR GRADE 1 AND MODERATE WAS NOTED, ALONG WITH A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). ON (B)(6) 2023, THE SLDA WAS OBSERVED AGAIN WITH ONE OF THE TWO TRICLIPS (TCDS0303-XTW, 10518R1038). REPORTEDLY, THE OTHER IMPLANTED CLIP WAS FUNCTIONING PROPERLY. THE PATIENT HAD NO ASSOCIATED CLINICAL SYMPTOMS AT THIS TIME. ON (B)(6) 2024, THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH HYPOTENSION, DYSPNEA, PLEURAL EFFUSIONS, PULMONARY CONGESTION, PERIPHERAL EDEMA, RECURRENT TR, MITRAL REGURGITATION (MR), AND WORSENING HEART FAILURE WAS DIAGNOSED. MEDICATIONS WERE PROVIDED AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. CHRONIC HEART FAILURE DUE TO MR AND TR WAS DIAGNOSED. REPORTEDLY, THE REGURGITATION WAS NOT UNDER CONTROL. THE PATIENT WAS IN END-STAGE HEART FAILURE, DISCHARGED WITH HOME OXYGEN AND PALLIATIVE CARE. ON (B)(6) 2024, THE PATIENT PASSED AWAY. PER PHYSICIAN, THE ADVERSE EVENTS WERE UNLIKELY DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678117 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL 10518R1038

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Male Death 1 TRICLIP.