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

Model Number	TCDS0801-XT
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 5 functional tricuspid regurgitation (tr) and a pacer lead pining the posterior leaflet for a triclip procedure.During the procedure, a triclip was intended to be implanted in the anterior-posterior (a/p) leaflet position while pining the heart monitor lead into the ap canyon.During positioning, the clip was successfully placed but there were challenges visualizing the insertion of the leaflets within the clip.The clip was successfully deployed when it was visualized that the clip was only attached to the anterior leaflet.A second clip was intended to be placed centrally on the anterior/septal (a/s) leaflets.During positioning, the clip became caught on the septal chordae.Troubleshooting was performed and the f-knob was turned significantly, outside of the ifu, when the f-knob cable broke.The +/- knob on the steerable guide catheter (sgc) was utilized to maneuver the clip into the a/s commissure.The clip was deployed successfully on both leaflets with some chordae attached.The procedure was discontinued, final mr was reduced to grade 4.There were no adverse patient sequela or clinically significant delays reported.

• 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: 25382936
• Report Number: 2135147-2026-03760
• Device Sequence Number: 9187983
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)271006(10)60407R1027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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-XT
• Device Catalogue Number: TCDS0801-XT
• Device Lot Number: 60407R1027
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• 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: TRICLIP STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female