MAUDE Adverse Event Report: Abbott Medical TriClip G5 Delivery System; tricuspid valve repair device, percutaneously delivered

Model Number	TCDS0801-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	08/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 06 august 2026 that the patient presented with grade 4 mixed tricuspid regurgitation (tr), enlarged atrium, prolapsed anterior and thin leaflet for a triclip procedure.Imaging was sub-optimal due to patient's complex anatomy.During the procedure, a triclip was successfully implanted.Post deployment, the clip had single leaflet device attachment (slda) from the septal leaflet.An attempt was made to deploy second clip for stabilization of slda, although the clip was removed from the anatomy as significant tr reduction was unable to be achieved.The tr remained unchanged post procedure.There was no clinically significant delay 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 this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the information reviewed, the reported incomplete coaptation appears to be related to a combination of patient anatomy/pathology and procedural conditions.The reported difficulty visualizing the clip appears to be related to patient anatomy/pathology.The reported patient effects of tr appears to be related to the slda.Tr, as listed in the triclip system instructions for use, are known possible complications associated with triclip procedures.The reported unexpected medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: TriClip G5 Delivery 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 ; +1(651)756-5400
• MDR Report Key: 50431669
• Report Number: 2135147-2026-05777
• Device Sequence Number: 13053406
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• UDI-Public: (01)05415067050731(17)261027(10)50429R1062
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TCDS0801-XTW
• Device Catalogue Number: TCDS0801-XTW
• Device Lot Number: 50429R1062
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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: 84 YR
• Patient Sex: Male
• Patient Weight: 239 LB