MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G4 SYSTEM; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TCDS0301-XTW
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 4 on a patient with a prominent eustachian valve.A triclip steerable guide catheter and a triclip was inserted.However, the device was interacting with the eustachian valve in a way that was preventing the ability to steer and manipulate the clip delivery system (cds) as intended.Due to these challenges, difficulty understraddling the clip back into the guide occurred, but were finally able to get the clip back into the guide.Therefore, the tsgc and cds were removed from the patient.The tsgc was inspected, and there was no damage observed.Therefore, a new tsgc and a new triclip was used to complete the procedure.One clip was implanted, reducing tr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
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 reported difficult to remove cds from sgc was likely due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional clarified information was received: it was reported that a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 4 on a patient with a prominent eustachian valve.A triclip was inserted and deployed on the tricuspid valve.A second clip, a triclip was then inserted and steered down to the valve.However, there was very little height above the valve and difficult trajectory.An attempt to open and orient the clip was made, but the clip ended up under one of the leaflets.The clip was inverted and brought back to the right atrium (ra).Troubleshooting was performed, but the clip was still unable to be achieve a good position.After several attempts, the clip was retracted back into the steerable guide catheter (sgc).However, it was observed that the sgc was interacting with the eustachian valve in a way that was preventing the ability to steer and manipulate the clip delivery system (cds) as intended.Due to these challenges, difficulty understradling the clip back into the tscg occurred.Several attempts were made to get the clip back into the sgc, and the clip was ultimately able to get back into the tsgc.Therefore, a decision was made to remove the clip and tsgc.The clip and the tsgc were removed and replaced.A new tsgc and a new clip were then inserted and deployed on the tricuspid valve, reducing tr to a grade of 1.While outside of the patient, the tsgc was inspected, and there was no damage observed.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: TRICLIP G4 SYSTEM
• Common Device Name: TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23889872
• Report Number: 2135147-2025-07710
• Device Sequence Number: 11929463
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260820(10)50821R1067
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50821R1067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female