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

Model Number	TCDS0801-XT
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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 a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 5.A triclip xt was inserted and deployed on the tricuspid valve.A second clip, a triclip xt was then inserted and advanced to the valve.However, during deployment, difficulties detaching clip from the clip delivery system (cds) occurred.It was noted that the clip was finally released after some efforts.The cds was removed from the patient, and the patient was completed with two clips implanted, reducing tr with a grade of 1-2.It was noted that patient remained hemodynamically stable throughout the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 24840044
• Report Number: 2135147-2026-02338
• Device Sequence Number: 14955479
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)270715(10)60115R1008
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 06/05/2026

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: 60115R1008
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/31/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• 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: 1 IMPLANTED TRICLIP; TRICLIP STEERABLE GUIDE CATHETER
• Patient Sex: Unknown