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

Model Number	TCDS0801-XT
Medical Device Problem Codes	Difficult to Remove (1528); Unintended Movement (3026)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 5 functional tricuspid regurgitation (tr) and rotated heart for a triclip procedure.During the procedure, triclip was advanced into the tricuspid valve and when tried to retract into the right atrium, clip got stuck in the chordae and flail segment was observed.Lock knob was removed, lock was tested and the clip was opened to 60 degrees.Physician unlocked the clip, relocked, closed and tested the lock, clip opened to 60 degrees.Physician unlocked the clip, opened to 120 degrees, relocked and closed the clip.Physician tested twice before deployment sequence and was implanted.All steps were performed as per ifu.The final tr was grade 2.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
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: 50119852
• Report Number: 2135147-2026-05279
• Device Sequence Number: 10480992
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)270518(10)51118R1019
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/28/2026

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 Model Number: TCDS0801-XT
• Device Catalogue Number: TCDS0801-XT
• Device Lot Number: 51118R1019
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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: Other
• Patient Sex: Male