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

Model Number	TCDS0801-NTW
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	11/12/2025
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 on (b)(6) 2025, a patient presented with grade 3+ severe focal functional posterior septal tricuspid regurgitation (tr), restricted short septal leaflet for a triclip procedure.During the procedure, triclip was placed on the medial side of posterior and septal leaflet (p/s) below the tricuspid ring.Triclip was moved to the aortic, grippers were raised and clip was unlocked, it was determined that the clip was stuck on the septal leaflet and ring.Trouble shooting was performed, but the clip was unable to be removed from the septal ring.Significant force was required to remove the clip.Therefore, the clip was deployed on the septal leaflet.All steps were performed as per ifu during the preparation.Imaging was difficult due to tricuspid ring.All steps were performed as per ifu.The final tr was unchanged.There were no clinically significant delays or adverse patient sequela 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 the reported entrapment of device or poor imaging.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported entrapment of device appears to be related to procedural conditions (clip stuck on septal leaflet and ring during positioning).The reported poor imaging is related to patient condition (shadowing from tricuspid ring), per case details.The reported unchanged tricuspid regurgitation and foreign body in patient are cascading events of the entrapment of device.The reported patient effect of tricuspid regurgitation, as listed in the triclip g5 system instructions for use, is a known possible complication associated with triclip procedures.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.Code 4614 was removed.

• Brand Name: TRICLIP G5 DELIVERY SYSTEM
• Common Device Name: TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 23721594
• Report Number: 2135147-2025-07142
• Device Sequence Number: 18729563
• Product Code: NPS
• UDI-Device Identifier: 05415067050816
• UDI-Public: (01)05415067050816(17)260923(10)50326R1022
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/27/2026

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: 09/23/2026
• Device Model Number: TCDS0801-NTW
• Device Catalogue Number: TCDS0801-NTW
• Device Lot Number: 50326R1022
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: TRICUSPID STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic