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

Model Number	TCDS0301-XT
Medical Device Problem Codes	Incomplete Coaptation (2507); Migration (4003)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 5+ functional tricuspid regurgitation (tr) with pacemaker lead for a triclip procedure.During the procedure, 2 mitraclips were implanted successfully on the anterior and septal leaflets.The final tr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, tee (transesophageal echocardiogram) was performed where it was determined that there was a movement of clip and single leaflet device attachment (slda) from anterior leaflet.Imaging was difficult.Per the physician, the partial clip movement and slda was due to so much pressure on the clip as patient has decided to stop taking the medications which lead to heart dilating.Tr was grade 3-4 after slda.Additional triclip was implanted on the anterior and septal leaflet for stabilization.The tr was reduced to grade 1-2.
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 the information reviewed, a cause for the reported single leaflet device attachment (slda) and partial clip movement appears to be related to procedural conditions.The reported image resolution poor could not be conclusively determined.Tricuspid valve regurgitation was a cascading effect of slda.Tricuspid valve regurgitation is a known possible complication associated with triclip procedures.The reported hospitalization and unexpected medical intervention were the result of case specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 5+ functional tricuspid regurgitation (tr) with pacemaker lead for a triclip procedure.During the procedure, 2 mitraclips were implanted successfully on the anterior and septal leaflets.The final tr was grade 1-2.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025, tee (transesophageal echocardiogram) was performed where it was determined that there was a movement of clip and single leaflet device attachment (slda) from anterior leaflet.Imaging was difficult.Per the physician, the partial clip movement and slda was due to so much pressure on the clip as patient has decided to stop taking the medications which lead to heart dilating.Tr was grade 3-4 after slda.Additional triclip was implanted on the anterior and septal leaflet for stabilization.The tr was reduced to grade 1-2.
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.

• 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: 23593951
• Report Number: 2135147-2025-06740
• Device Sequence Number: 10155492
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260210(10)50211R2031
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/20/2026

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 Expiration Date: 02/10/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50211R2031
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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.; TRICLIP.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male