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

Model Number	TCDS0801-XTW
Medical Device Problem Codes	Positioning Failure (1158); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2026
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) for a triclip procedure.During the procedure, while trying to grasp the leaflets first triclip, it was unable to grasp both the leaflets.It was observed that lateral leaflet was caught between the gripper and the shaft of clip delivery system (cds).Multiple maneuvers were attempted to freed the clip but was unsuccessful.Clip was deployed on chordae and lateral leaflet.Additional clip was implanted to stable the first clip.All steps were performed as per ifu.Imaging was difficult.The final tr was grade 3.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: 50898580
• Report Number: 2135147-2026-06515
• Device Sequence Number: 10684218
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• UDI-Public: (01)05415067050731(17)270823(10)60220R2074
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 60220R2074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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: Steerable guide catheter
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 191 LB
• Patient Race: White