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

Model Number	TCDS0301-XT
Medical Device Problem Codes	Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Expulsion (2933); Unintended Movement (3026)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.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) 2026, a patient presented with grade 4 degenerative tricuspid regurgitation (tr) and rotated heart for a triclip procedure and with mitral regurgitation (mr) for mitraclip procedure.During the procedure, a steerable guide catheter was unable to cross the septum and unable to treat the mitral valve.It was decided to treat the tr.Triclip was stuck in the tissue and was deployed in the right atrium.Clip was deployed prior to removing the lock line.While removing the lock line, the clip was opened.After deployment, the clip was embolized, moved across the atrial septal defect (asd) into the left atrium and lodging into the pulmonary vein.Imaging was difficult.Patient was sent to the open-heart surgery, and the surgeon successfully removed the device and repaired the tricuspid valve.The final tr was grade 4.There were no adverse patient effects 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 the reported entrapment of device, expulsion, unintended movement (clip open - locked), improper or incorrect procedure or method, or poor imaging.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on available information, the reported entrapment of device appears to be related to procedural conditions (clip contacted tissue and was unable to be released).The reported expulsion, clip opening while locked, embolism, and tricuspid regurgitation appear to be cascading events of the improper or incorrect procedure or method.The reported poor imaging appears to be related to procedural conditions.The reported improper or incorrect procedure or method was associated with the user deploying the clip without following the correct deployment steps.It was determined that this deviation likely contributed to the reported adverse events; therefore, a letter will be sent to the account to address the deviation from the instructions for use (ifu) and its associated potential adverse events.The reported patient effects of embolism and tricuspid regurgitation, as listed in the triclip g4 system instructions for use, are known possible complications associated with triclip procedures.The reported surgical intervention, unexpected medical intervention, and removal of foreign body were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 24470062
• Report Number: 2135147-2026-01210
• Device Sequence Number: 13138247
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260922(10)50923R1010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/22/2026

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: 09/22/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50923R1010
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 75 KG