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

Model Number	TCDS0801-XTW
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Unspecified Tissue Injury (4559)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4-5 degenerative tricuspid regurgitation (tr), dilated atrium for a triclip procedure.During the procedure, tissue got stuck in the closed clip.It was unable to be removed.Clip started coming off from the release pin and was only attached to the lockline.Clip was pulled back into inferior venacava and into the femoral vein.Small incision was made to remove the system.Patient was sutured and procedure was attempted on the left side successful.It was noted that femoral vein was damaged.All steps were performed as per ifu.The final tr was grade <1.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4-5 degenerative tricuspid regurgitation (tr), dilated atrium for a triclip procedure.During the procedure, tissue got stuck in the closed clip.It was unable to be removed.Clip started coming off from the release pin and was only attached to the lockline.Clip was pulled back into inferior venacava and into the femoral vein.Small incision was made to remove the system.Patient was sutured and procedure was attempted on the left side successful.It was noted that femoral vein was damaged.All steps were performed as per ifu.The final tr was grade <1.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated, and the reported difficult to remove from the anatomy resulting in unspecified tissue injury, premature activation and subsequent perforation of vessels appears to be related to procedural conditions.Tissue damage is a known possible complication associated with triclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 50762691
• Report Number: 2135147-2026-06213
• Device Sequence Number: 18529407
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• UDI-Public: (01)05415067050731(17)270907(10)60309R1067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TCDS0801-XTW
• Device Catalogue Number: TCDS0801-XTW
• Device Lot Number: 60309R1067
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown