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

Model Number	TCDS0301-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Tachycardia (2095); Tricuspid Valve Insufficiency/ Regurgitation (4453); Unspecified Tissue Injury (4559)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The additional triclip device mentioned in b5 and d10 had been filed under a separate medwatch report number.The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 a patient presented with grade 4 functional tricuspid regurgitation (tr) and an enlarged atrium for a triclip procedure.One triclip xtw on the mid septal and anterior leaflet segments and one triclip xt was implanted on the central septal and anterior leaflet segments.The final tr grade was 1-2.On (b)(6) 2025 the patient presented with symptomatic episodes of non-sustained ventricular tachycardia (nsvt).A transthoracic echocardiogram (tte) was performed and it was noted that the clips were in place and stable.Amiodarone, mexiletine and diuretics were administered.An electrophysiology consultation determined the nsvt originated from the tricuspid valve annulus.On (b)(6) 2025 a transesophageal echocardiogram (tee) was performed and two single leaflet device attachments (slda) were observed.Both clips detached from the septal leaflet and remained attached to the anterior leaflet.On the transgastric, the septal leaflet appeared shorter than pre-procedure and was suspected to have torn.The tr grade increased to 3-4.Per the physician the slda was due to "friable leaflets".
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 identified no similar complaints reported from this lot.The investigation determined the reported slda appears to be related to patient morphology/pathology.The reported tricuspid valve insufficiency/ regurgitation appears to be due to the slda.The reported tachycardia and tissue injury (septal leaflet torn) could not be determined.Tricuspid valve insufficiency/ regurgitation, tachycardia, and tissue injury are listed in the instructions for use as a known possible complication associated with the triclip procedures.The reported hospitalization and medication required were a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 a patient presented with grade 4 functional tricuspid regurgitation (tr) and an enlarged atrium for a triclip procedure.One triclip xtw on the mid septal and anterior leaflet segments and one triclip xt was implanted on the central septal and anterior leaflet segments.The final tr grade was 1-2.On (b)(6) 2025 the patient presented with symptomatic episodes of non-sustained ventricular tachycardia (nsvt).A transthoracic echocardiogram (tte) was performed and it was noted that the clips were in place and stable.Amiodarone, mexiletine and diuretics were administered.An electrophysiology consultation determined the nsvt originated from the tricuspid valve annulus.On (b)(6) 2025 a transesophageal echocardiogram (tee) was performed and two single leaflet device attachments (slda) were observed.Both clips detached from the septal leaflet and remained attached to the anterior leaflet.On the transgastric, the septal leaflet appeared shorter than pre-procedure and was suspected to have torn.The tr grade increased to 3-4.Per the physician the slda was due to "friable leaflets".

• 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: 22036727
• Report Number: 2135147-2025-02573
• Device Sequence Number: 15489331
• Product Code: NPS
• UDI-Device Identifier: 05415067047731
• UDI-Public: (01)05415067047731(17)251031(10)41031R1047
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/28/2025

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: 10/31/2025
• Device Model Number: TCDS0301-XT
• Device Catalogue Number: TCDS0301-XT
• Device Lot Number: 41031R1047
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: IMPLANTED TRICLIP
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White