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

Model Number	TCDS0801-XT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
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) and tethered leaflet for a triclip procedure.During the procedure, it was noted that clip got stuck in the chords below the valve.It was able to free the clip from the chords and moved into the atrium.It was decided to remove the second clip as mandrel was bent.It was attempted to pull the clip back into the guide and it was noticed that one of the clip arms would not come into the guide due to the mandrel being visibly bent.Physician was able to pull the triclip steerable guide catheter (tsgc) and clip delivery system (cds) into the groin.Vascular surgeon came in and cut down to the vein to remove the clip.The final tr was grade 2.All steps were performed as per ifu.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 09 april 2026, a patient presented with grade 4 functional tricuspid regurgitation (tr) and tethered leaflet for a triclip procedure.During the procedure, it was noted that clip got stuck in the chords below the valve.It was able to free the clip from the chords and moved into the atrium.It was decided to remove the second clip as mandrel was bent.It was attempted to pull the clip back into the guide and it was noticed that one of the clip arms would not come into the guide due to the mandrel being visibly bent.Physician was able to pull the triclip steerable guide catheter (tsgc) and clip delivery system (cds) into the groin.Vascular surgeon came in and cut down to the vein to remove the clip.The final tr was grade 2.All steps were performed as per ifu.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) and tethered leaflet for a triclip procedure.During the procedure, it was noted that clip got stuck in the chords below the valve.It was able to free the clip from the chords and moved into the atrium.It was decided to remove the second clip as mandrel was bent.It was attempted to pull the clip back into the guide and it was noticed that one of the clip arms would not come into the guide due to the mandrel being visibly bent.Physician was able to pull the triclip steerable guide catheter (tsgc) and clip delivery system (cds) into the groin.Vascular surgeon came in and cut down to the vein to remove the clip.The final tr was grade 2.All steps were performed as per ifu.There were no adverse patient effects or clinically significant delays 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 the reported shaft deformation, difficulty removing the cds through the sgc, or difficult or delayed positioning.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported shaft deformation, difficulty removing the cds through the sgc, and difficult or delayed positioning are related to procedural conditions (caught on chords during positioning, force applied when retracting clip back above valve).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.
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 shaft deformation, difficulty removing the cds through the sgc, or difficult or delayed positioning.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported shaft deformation, difficulty removing the cds through the sgc, and difficult or delayed positioning are related to procedural conditions (caught on chords during positioning, force applied when retracting clip back above valve).The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Codes removed: health effect- impact code: 4641.

• 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: 25071920
• Report Number: 2135147-2026-02950
• Device Sequence Number: 18746639
• Product Code: NPS
• UDI-Device Identifier: 05415067050847
• UDI-Public: (01)05415067050847(17)261130(10)50602R1060
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 09/18/2026

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-XT
• Device Catalogue Number: TCDS0801-XT
• Device Lot Number: 50602R1060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 08/26/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/29/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown