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	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains 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.
Event or Problem Description
On (b)(6) 2025 that the patient presented with grade 5+ functional tricuspid regurgitation (tr) and dilated right atrium for a triclip procedure.During the procedure, 3 triclips were successfully implanted.The tr was reduced to grade 1+ post procedure.On (b)(6) 2025, the third triclip had single leaflet device attachment(slda).There was no clinically significant delay.
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 the reported incomplete coaptation.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on available information, a cause for the reported incomplete coaptation - single leaflet device attachment (slda) could not be determined.The reported recurrent tricuspid valve insufficiency/ regurgitation appears to be a cascading effect of the reported slda.Tr is listed in the instructions for use as a known possible complication associated with the triclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances as no intervention was reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: health effect-clinical code: 4582, health effect- impact code: 2199.Codes added: health effect-clinical code: 4453, health effect- impact code: 4614.
Event or Problem Description
On (b)(6) 2025, the patient presented with grade 5+ functional tricuspid regurgitation (tr) and dilated right atrium for a triclip procedure.During the procedure, 3 triclips were successfully implanted.The tr was reduced to grade 1+ post procedure.On (b)(6) 2025, the third triclip had single leaflet device attachment(slda) from the septal leaflet.Recurrent tr of grade 3 was reported.There was no clinically significant delay.

• 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: 23853904
• Report Number: 2135147-2025-07563
• Device Sequence Number: 20115860
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260211(10)50212R1003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/17/2026

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: 02/11/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50212R1003
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/17/2026
• 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 Age: 65 YR
• Patient Sex: Male