MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Model Number	CDS0706-XT
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that the patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, one mitraclip was implanted successfully.During deployment of second mitraclip, gripper got caught in the chordae.Troubleshooting was performed and another gripper got stuck in posterior chordae.The grippers were free after performing standard troubleshooting.The actuator knob was able to turn but the clip was unable to release.The grippers were able to lower and the leaflets were captured in the clip and was deployed successfully.The mr was reduced to grade 2 post procedure.There was no clinically significant delay or adverse patient effects.
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 difficult to open or close (gripper actuation - both), difficult or delayed activation (clip deployment), or difficult or delayed positioning (anatomy).Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported difficult or delayed positioning (anatomy) is related to procedural conditions (gripper caught on chordae during deployment).Causes for the reported difficult gripper actuation and difficult or delayed clip deployment could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2025 that the patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, one mitraclip was implanted successfully.During deployment of second mitraclip, gripper got caught in the chordae.Troubleshooting was performed and another gripper got stuck in posterior chordae.The grippers were free after performing standard troubleshooting.The actuator knob was able to turn but the clip was unable to release.The grippers were able to lower and the leaflets were captured in the clip and was deployed successfully.The mr was reduced to grade 2 post procedure.There was no clinically significant delay or adverse patient effects.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23213391
• Report Number: 2135147-2025-05663
• Device Sequence Number: 21115000
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260410(10)50411A1098
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• 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): 11/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50411A1098
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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: MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Age: 85 YR
• Patient Sex: Female