MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G5 DELIVERY SYSTEM; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TCDS0801-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
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) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, two triclips were implanted.The final tr was grade 2.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2026 under transthoracic echocardiogram (tte)it was determined that there was a single leaflet device attachment (slda) for second clip and the clip was no longer attached to the posterior leaflet.Patient had shortness of breath on the next day.Tr was grade 2 after slda.

• Brand Name: TRICLIP G5 DELIVERY 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: 24944480
• Report Number: 2135147-2026-02613
• Device Sequence Number: 17453410
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)270407(10)51008R1093
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/15/2026

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 Model Number: TCDS0801-XT
• Device Catalogue Number: TCDS0801-XT
• Device Lot Number: 51008R1093
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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
• Patient Sex: Unknown