MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G4 SYSTEM; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TCDS0301-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning 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 on 14 may 2025 a patient presented with grade 4 functional tricuspid regurgitation (tr) and a tethered septal leaflet for a triclip procedure.Reportedly, imaging was difficult.Upon deployment of the triclip xt a single leaflet device attachment (slda) was observed.The clip detached from the anterior leaflet and remained attached to the septal leaflet.The tr grade remained at 4.
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 available information, the cause of the reported slda was unable to be determined.The reported patient effect of tricuspid regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: health effect- impact code: 2199 no consequences or impact to patient.

• Brand Name: TRICLIP G4 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: 22162214
• Report Number: 2135147-2025-03019
• Device Sequence Number: 15270434
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260107(10)50107R1101
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50107R1101
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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: Other
• Patient Sex: Unknown