MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G5 DELIVERY SYSTEM; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TCDS0801-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, a triclip xt was successfully placed on the mid anterior- septal (a/s) leaflet position.Upon deployment, a single leaflet detachment (slda) occurred and the clip was no longer attached to the septal leaflet.A second triclip xt was successfully placed anterior to the slda clip for stabilization.A third triclip xt was then implanted centrally on the a/s segment to reduce tr.The procedure was discontinued, the final tr was grade <1.There were no adverse patient sequela or clinically significant delays reported.
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 did not indicate a lot-specific quality issue.Based on the information reviewed, a cause for the reported single leaflet device attachment (slda) appears to be related to a combination of patient morphology/pathology due to restricted leaflet and procedural factors due to difficulty visualizing the clip.The reported difficulty visualizing the clip appears to be related to patient anatomy and poor imaging windows.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.

• 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: 24682392
• Report Number: 2135147-2026-01873
• Device Sequence Number: 9652831
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)270611(10)51212R1024
• 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
• Report Date (Section B): 03/24/2026

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: 51212R1024
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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: Unknown