MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP¿ STEERABLE GUIDE CATHETER; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TSGC0201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, triclip steerable guide catheter and triclip were advanced in right atrium(ra).A thrombus was noticed on the wall of the ra.The triclip was removed from the anatomy.An aspiration attempt was made to remove thrombus from the anatomy.The thrombus was no longer visible in imaging and the procedure was continued as per the protocol.The mr was reduced to grade 3 post procedure.There was no clinically significant delay.
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 thrombus.Based on available information, a cause for the reported thrombus could not be conclusively determined.The reported patient effect of thrombosis/thrombus, as listed in the triclip system instructions for use, is a known possible complication associated with triclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality 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 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, triclip steerable guide catheter and triclip were advanced in right atrium(ra).A thrombus was noticed on the wall of the ra.The triclip was removed from the anatomy.An aspiration attempt was made to remove thrombus from the anatomy.The thrombus was no longer visible in imaging and the procedure was continued as per the protocol.The mr was reduced to grade 3 post procedure.There was no clinically significant delay.
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 thrombus.Based on available information, a cause for the reported thrombus could not be conclusively determined.The reported patient effect of thrombosis/thrombus, as listed in the triclip 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.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, triclip steerable guide catheter and triclip were advanced in right atrium(ra).A thrombus was noticed on the wall of the ra.The triclip was removed from the anatomy.An aspiration attempt was made to remove thrombus from the anatomy.The thrombus was no longer visible in imaging and the procedure was continued as per the protocol.The mr was reduced to grade 3 post procedure.There was no clinically significant delay.

• Brand Name: TRICLIP¿ STEERABLE GUIDE CATHETER
• 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: 23184365
• Report Number: 2135147-2025-05541
• Device Sequence Number: 9843796
• Product Code: DQY
• UDI-Device Identifier: 05415067047748
• UDI-Public: (01)05415067047748(17)260805(10)50205R1022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K241538
• 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,Followup
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2026
• Device Model Number: TSGC0201
• Device Catalogue Number: TSGC0201
• Device Lot Number: 50205R1022
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 12/03/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2025
• 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: 2 TRICLIPS.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 62 KG