MAUDE Adverse Event Report: Abbott Medical TriClip G4 System; Tricuspid Valve Repair Device, Percutaneously Delivered

Model Number	TCDS0301-XTW
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fatigue (1849); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	08/24/2026
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.The tr was reduced to grade 2 post procedure.On an unknown day in (b)(6) 2026, patient returned symptomatic with recurrent tr of grade 4 and fatigue was noted.The second triclip xtw was observed to be tilted and partially detached from posterior leaflet in transesophageal echocardiogram (tee).There was no clinically significant delay reported.
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 migration.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported clip migration could not be determined.The reported tr and fatigue appear to be cascading effects of the clip migration.Additionally, the reported patient effect of tricuspid regurgitation is listed in the triclip g4 system instructions for use, and is a known possible complication associated with triclip procedures.The reported serious injury/ illness/ impairment was a result 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 ; +1(651)756-5400
• MDR Report Key: 50694686
• Report Number: 2135147-2026-06080
• Device Sequence Number: 13160571
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2025
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 41211R1086
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TriClip
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male