BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 23794862 · Received December 12, 2025

    Report

    Report Number
    2135147-2025-07342
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 18, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    UDI-DI
    05415067045560
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED ENTRAPMENT OF THE DEVICE IN THE ATRIAL SEPTUM APPEARS WAS DUE TO THE DEVICE BEING UNINTENTIONALLY MOVED INTO THE PATENT FORAMEN OVALE (PVO). THE CAUSE OF THE UNINTENDED MOVEMENT INTO THE PVO APPEARS TO BE DUE TO PROCEDURAL CIRCUMSTANCES. THE REPORTED POOR IMAGING APPEARS TO BE RELATED TO PATIENT CONDITION. A CAUSE OF THE REPORTED SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) COULD NOT BE DETERMINED. THE REPORTED PERFORATION WAS A CASCADING EFFECT OF THE ENTRAPMENT AND SUBSEQUENT MANEUVERS TO FREE THE DEVICE. PERFORATION IS A LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE TRICLIP PROCEDURES. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS THE RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT MIXED TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 AND ENLARGED ATRIUM, ON A PATIENT WITH PACEMAKER (PM) LEADS. A TRICLIP XTW WAS INSERTED. HOWEVER, DIFFICULTIES WITH IMAGING OCCURRED, AND WHILE STEERING DOWN FROM THE SUPERIOR VENA CAVA (SVC) INTO THE RIGHT ATRIUM (RA), THE CLIP UNINTENTIONALLY MOVED INTO THE PATENT FORAMEN OVALE (PVO). TROUBLESHOOTING WAS PERFORMED, AND AFTER SEVERAL MOVEMENTS, THE CLIP BECAME FREE FROM THE ATRIAL SEPTUM. HOWEVER, IT WAS OBSERVED THAT A PERFORATION OF THE SEPTUM OCCURRED. THE CLIP WAS THEN POSITIONED IN THE VALVE AND GRASPING WAS PERFORMED. THE CLIP WAS DEPLOYED ON THE TRICUSPID VALVE. HOWEVER, DIFFICULTIES WITH IMAGING OCCURRED, AND POST DEPLOYMENT, THE CLIP DETACHED FROM THE SEPTAL LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE SLDA CLIP AND FURTHER REDUCE TR, A SECOND CLIP WAS IMPLANTED, REDUCING TR TO A GRADE OF 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762057 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL TCDS0307-XTW 50708R1035 05415067045560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention TRICLIP STEERABLE GUIDE CATHETER