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

Model Number	TCDS0301-XT
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 5+ functional tricuspid regurgitation for a triclip procedure.During device preparation, it was identified that the triclip xt was damaged.The clip was discarded and a new clip was selected.A new triclip xt was selected and implanted successfully.The final tr was reduced to grade 1+.There were no adverse patient effects or clinically significant delays.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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 broken gripper line was due to preparation circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: medical device problem code: 2915.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 5+ functional tricuspid regurgitation for a triclip procedure.During device preparation, it was identified that the triclip xt was damaged.The clip was discarded and a new clip was selected.A new triclip xt was selected and implanted successfully.The final tr was reduced to grade 1+.There were no adverse patient effects or clinically significant delays.

• 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: 23751552
• Report Number: 2135147-2025-07235
• Device Sequence Number: 17618289
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260520(10)50521R1100
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/13/2026

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: 05/20/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50521R1100
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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 Sex: Unknown