MAUDE Adverse Event Report: Abbott Medical TriClip G5 Delivery System; tricuspid valve repair device, percutaneously delivered

Model Number	TCDS0801-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 5+ on a patient with 4 leaflets with a central gap and a previous aortic valve replacement and a previous left atrial appendage (laa) closure device.A triclip was inserted and deployed on the tricuspid valve.However, difficulties visualizing the clip occurred, and post deployment, the clip detached from the anterior leaflet and remained attached to the other leaflet (single leaflet device attachment/slda).A second clip, a triclip xtw was then inserted and deployed on the tricuspid valve, reducing tr to a grade of 4-5.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device 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.

• 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 ; +1(651)756-5400
• MDR Report Key: 50736864
• Report Number: 2135147-2026-06164
• Device Sequence Number: 13409710
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• UDI-Public: (01)05415067050731(17)270112(10)50715R1020
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TCDS0801-XTW
• Device Catalogue Number: TCDS0801-XTW
• Device Lot Number: 50715R1020
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TriClip steerable guide catheter
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White