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

Model Number	TCDS0301-XT
Medical Device Problem Codes	Incomplete Coaptation (2507); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 5 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, 2 triclips were implanted successfully.The tr was reduced to grade 1 post procedure.On (b)(6) 2025, first triclip was observed to have single leaflet device attachment(slda) from septal leaflet.Due to the movement of first triclip, second triclip also had slda from septal leaflet.The patient returned with recurrent tr of grade 3.There was no clinically significant delay.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned 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.The investigation was unable to determine the cause for the reported device damaged by another device (caused damage).The reported single leaflet device attachment (slda) resulting in tricuspid valve regurgitation appears to have been a cascading effect of the device being damaged by another device.Tricuspid valve regurgitation is a known possible complication associated with triclip procedures.The reported serious injury/illness/impairment was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 23442107
• Report Number: 2135147-2025-06307
• Device Sequence Number: 14648228
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260211(10)50211R3049
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/21/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50211R3049
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown