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 or Delayed Positioning (1157); Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
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 on a patient with prominent eustachian valve, enlarged heart, rotated heart, and a cardiac implantable electronic device (cied) with pacing leads.A triclip was inserted and implanted without issues.A second clip, a triclip xt was inserted and grasping was performed.However, difficulties visualizing the clip and difficulties capturing the leaflets occurred.The clip was ultimately deployed on the tricuspid valve.However, post deployment, the clip detached from the anterior (lateral) leaflet and remained attached to the septal leaflet (single leaflet device attachment/slda).To stabilize the clip, two additional clips were implanted, reducing tr with a grade of 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported slda and difficult leaflet capture were unable to be determined.The reported difficult imaging was due to patient anatomy.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: medical device problem code:.
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 prominent eustachian valve, enlarged heart, rotated heart, and a cardiac implantable electronic device (cied) with pacing leads.A triclip was inserted and implanted without issues.A second clip, a triclip xt was inserted and grasping was performed.However, difficulties visualizing the clip and difficulties capturing the leaflets occurred.The clip was ultimately deployed on the tricuspid valve.However, post deployment, the clip detached from the anterior (lateral) leaflet and remained attached to the septal leaflet (single leaflet device attachment/slda).To stabilize the clip, two additional clips were implanted, reducing tr with a grade of 3-4.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: 24613325
• Report Number: 2135147-2026-01684
• Device Sequence Number: 13219986
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)270517(10)51114R1087
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TCDS0801-XT
• Device Catalogue Number: TCDS0801-XT
• Device Lot Number: 51114R1087
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: 1 IMPLANTED TRICLIP.; TRICLIP STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown