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

Model Number	TCDS0301-XTW
Medical Device Problem Codes	Difficult to Remove (1528); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Cardiac Tamponade (2226); Pericardial Effusion (3271); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
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 that a triclip procedure was performed to treat severe tricuspid regurgitation (tr).A triclip xtw was inserted and advanced to tricuspid valve.However, it while in the right atrium (ra), it was observed that the clip became caught underneath the tricuspid valve apparatus.Therefore, the clip was retraced in the right atrium and re-sheathed.However, when the cds was pulled into the inferior vena cava, a large pericardial effusion with tamponade developed.The clip was removed from the patient, and the procedure was discontinued.However, the patient died.An autopsy was performed and revealed myocardial abrasions, a torn chordae tendinea where the cds was entangled, and large tear of the right atrial wall extending into the inferior vena cava.The autopsy had a finding of focal thickening of anterior tricuspid leaflet.The cause of death was due to an intraoperative tear of the heart and vena cava.No additional information was provided.
Additional Manufacturer Narrative
Subsequent to the initial report submission, this event was reassessed and determined to be a duplicate of complaint (b)(4), (mdr ref #: 2135147-2025-07390).As a result, this report, (b)(4) (mdr ref #: 2135147-2025-07645), should be retracted.All current and future information related to this event will be documented under mdr ref #: 2135147-2025-07390.Please reference (b)(4), (mdr ref #: 2135147-2025-07390) for all current and future information.
Event or Problem Description
N/a.

• 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: 23883017
• Report Number: 2135147-2025-07645
• Device Sequence Number: 4671824
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260820(10)50820R1083
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/04/2026

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 Expiration Date: 08/20/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50820R1083
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: Death
• Patient Sex: Unknown