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	Dyspnea (1816); Tricuspid Valve Insufficiency/ Regurgitation (4453); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented for a mitraclip procedure.During the procedure, one mitraclip was implanted successfully.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, it was identified that there was a single leaflet device attachment (slda) and the physician performed additional procedure.
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 did not indicate a lot-specific quality issue.Based on the information reviewed, a cause for the reported incomplete coaptation/ single leaflet device attachment (slda) could not be determined.The reported recurrent tricuspid valve insufficiency/ regurgitation (tr), dyspnea, and dyspnea on exertion appear to be a cascading effect of the reported slda.Tr and dyspnea are listed in the triclip system instructions for use as known possible complication associated with the triclip procedures.The reported hospitalization and surgical intervention were results of case specific circumstances as the patient was admitted and received a non-abbott transcatheter valve replacement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes 4582, 4641 were removed and codes 1816, 4453, 4607 were added.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 5 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, one triclip was implanted successfully.The final tr was grade 2.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, it was identified that there was a single leaflet device attachment (slda).Tr was grade 5 after slda and the physician performed additional procedure for valve replacement.Tr was grade 0 after additional procedure.

• 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: 23995666
• Report Number: 2135147-2026-00167
• Device Sequence Number: 18772583
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260211(10)50212R1023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/19/2026

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-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50212R1023
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female