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

Model Number	TCDS0801-XTW
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, transesophageal echocardiogram (tee) probe was not able to enter the stomach due to esophageal restriction.Mid and deep esophageal views were adequate, and ice imaging was adequate and physician decided to proceed.Right access was attempted and could not advance guide to the right atria due to torturous and restricted iliac.Attempt was made with the left access; it was difficult to advance and eventually advanced triclip steerable guide catheter (tsgc) into the right atria.Due to tortuosity, it was difficult for septal and lateral movements of the guide to translate.First triclip was attempted but ended up pulling back to inferior, physician decided to remove the clip and wanted to replace it with teh new clip.Second triclip xtw was introduced into the right atria, steered down to the tricuspid valve and was aligned in the atria within the desired location.Leaflets were grasped and due to less impact on the tr, physician moved the clip more central and crossed under the valve for the second attempt.During the second attempt to grasp the leaflets, clip got caught on the sub valvular chords.After several attempts, clip was able to retract into the atria but was evident that chordae were ruptured.During removal of the clip, clip was caught on the eustachian valve.Clip was successfully freed from the eustachian valve with some difficulty and pulled back into the tsgc.Devices were removed from the patient.The final tr was grade 4.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, transesophageal echocardiogram (tee) probe was not able to enter the stomach due to esophageal restriction.Mid and deep esophageal views were adequate, and ice imaging was adequate and physician decided to proceed.Right access was attempted and could not advance guide to the right atria due to torturous and restricted iliac.Attempt was made with the left access; it was difficult to advance and eventually advanced triclip steerable guide catheter (tsgc) into the right atria.Due to tortuosity, it was difficult for septal and lateral movements of the guide to translate.First triclip was attempted but ended up pulling back to inferior, physician decided to remove the clip and wanted to replace it with teh new clip.Second triclip xtw was introduced into the right atria, steered down to the tricuspid valve and was aligned in the atria within the desired location.Leaflets were grasped and due to less impact on the tr, physician moved the clip more central and crossed under the valve for the second attempt.During the second attempt to grasp the leaflets, clip got caught on the sub valvular chords.After several attempts, clip was able to retract into the atria but was evident that chordae were ruptured.During removal of the clip, clip was caught on the eustachian valve.Clip was successfully freed from the eustachian valve with some difficulty and pulled back into the tsgc.Devices were removed from the patient.The final tr was grade 4.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
In this case, the reported difficult to remove from the anatomy could not be replicated 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 the reported event.A review of the complaint history identified no similar complaints from the lot.Based on the information reviewed, the cause of the reported difficult to remove the clip from the anatomy resulting in tissue injury cannot be determined.Tissue damage is a known possible complication associated with triclip procedures.Serious injury/illness/impairment was a result of case-specific circumstances.There is no indication of a product 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: 50775754
• Report Number: 2135147-2026-06241
• Device Sequence Number: 18497894
• Product Code: NPS
• UDI-Device Identifier: 05415067050731
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 09/15/2026

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: 60219R2070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2026
• 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: 1XTriclip
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male