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

Model Number	TCDS0301-XTW
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484); Difficult to Remove (1528); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a triclip procedure was performed to treat functional tricuspid regurgitation (tr) with a grade of 4 on a patient with 4 to 5 leaflets.A triclip xtw was inserted and successfully deployed on the tricuspid valve.A second clip, a triclip xtw (50821r1018), was then inserted and grasping was performed.However, the leaflets were unable to be grasped, and it was observed that a gripper was not functioning as intended.Therefore, a decision was made to remove the clip.However, while removing the cds into the sgc, the clip detached from the tip.It was noted that the gripper lines stayed attached.A non-abbott sheath device was inserted and placed on the opposite side (left side) of the device and snared out of the patient.A third clip was then inserted, and grasping was performed.However, the leaflets were unable to be grasped or captured.Therefore, the clip was removed from the patient.The procedure was discontinued, and the tr was reduced to a grade of 3.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the previously filed report, the following information was corrected: the correct lot number for the second clip has been corrected to 50827r1034), as the clip 50821r1018 was the first clip implanted and implanted with success.
Additional Manufacturer Narrative
All available information was investigated.The returned device analysis was unable to replicate the reported positioning failure, difficult single gripper actuation, difficult cds removal through the sgc, and premature activation in a testing environment.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 reported positioning failure is related to challenging patient anatomy (4-5 tricuspid valve leaflets).A cause for the reported difficult single gripper actuation, difficult cds removal through the sgc, and premature activation could not be conclusively determined.The reported embolism is a cascading event of the premature activation.The reported patient effect of embolism, as listed in the triclip g4 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.

• 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: 24351417
• Report Number: 2135147-2026-00953
• Device Sequence Number: 4759461
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260826(10)50827R1034
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/19/2026

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: 08/26/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50827R1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/07/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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: 1 IMPLANTED TRICLIP; TRICLIP STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female