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

Model Number	TCDS0301-XT
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
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 a triclip procedure was performed to treat degenerative tricuspid regurgitation (tr) with a grade of 4-5.A triclip xt was inserted without issues.A decision was made to use fluoroscopy before using proper imaging to steer down to the valve.However, while steering down to the valve, the clip unintentionally moved and became stuck on the patent foramen ovale (pfo).Troubleshooting was performed to remove the tip of the clip out of the pfo but the clip could not be freed.In an attempt to remove the clip from the pfo, the clip was pulled for 45 minutes.However, the clip had started to detach from the mandrel.The clip was inverted.However, the clip completely detached from the mandrel, and hung on the lock line.A decision was made to remove the entire steerable guide catheter (sgc) all the way back to the incision point.A vascular surgeon then made another incision in the groin, and was able to remove the clip, and closed the groin.One clip was then inserted and successfully deployed on the tricuspid valve, reducing tr to a grade of 2-3.There was no clinically significant delay in the procedure.
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 unintended movement, positioning failure, or premature activation.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, a cause for the reported unintended movement could not be conclusively determined.The reported positioning failure (clip stuck in pfo) is a cascading event of the unintended movement.The reported premature activation appears to be a cascading event of the positioning failure (related to troubleshooting performed to remove clip from pfo).The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: type of investigation: 4118 types of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusions not yet available.
Event or Problem Description
It was reported that a triclip procedure was performed to treat degenerative tricuspid regurgitation (tr) with a grade of 4-5.A triclip xt was inserted without issues.A decision was made to use fluoroscopy before using proper imaging to steer down to the valve.However, while steering down to the valve, the clip unintentionally moved and became stuck on the patent foramen ovale (pfo).Troubleshooting was performed to remove the tip of the clip out of the pfo but the clip could not be freed.In an attempt to remove the clip from the pfo, the clip was pulled for 45 minutes.However, the clip had started to detach from the mandrel.The clip was inverted.However, the clip completely detached from the mandrel, and hung on the lock line.A decision was made to remove the entire steerable guide catheter (sgc) all the way back to the incision point.A vascular surgeon then made another incision in the groin, and was able to remove the clip, and closed the groin.One clip was then inserted and successfully deployed on the tricuspid valve, reducing tr to a grade of 2-3.There was no clinically significant delay in the procedure.

• 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: 22750252
• Report Number: 2135147-2025-04416
• Device Sequence Number: 13179836
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)260415(10)50415R1101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2026
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 50415R1101
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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 Sex: Unknown