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

Model Number	TCDS0301-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Tricuspid Valve Insufficiency/ Regurgitation (4453); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in the 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.
Event or Problem Description
It was reported on (b)(6) 2025, that the patient presented with grade 3 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, 2 triclips were implanted successfully.On (b)(6) 2025, one triclip had single leaflet device attachment(slda).There was no clinically significant delay or adverse patient effects.
Event or Problem Description
It was reported on 04 december 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 2 post procedure.On (b)(6) 2025, one triclip had single leaflet device attachment(slda).Recurrent tr of grade 5+ was reported.On (b)(6) 2025, a re-intervention procedure was performed.Additional triclip was implanted.There was no clinically significant delay.Codes 2199 and 4582 were removed.Code 4607, 4641- additional procedure and 4453-recurrent tr were as added.
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 from the lot.Based on the information reviewed, a cause for the reported slda could not be determined.The reported recurrent tricuspid valve insufficiency/regurgitation (tr) appears to be a cascading effect of the reported slda.The reported patient effect of tricuspid valve regurgitation is a known possible complication associated with triclip procedures.The reported hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality 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: 23923338
• Report Number: 2135147-2025-07794
• Device Sequence Number: 9082212
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260317(10)50318R1004
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/29/2026

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: 03/17/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50318R1004
• 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: 12/06/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown