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

Model Number	CDS0706-NT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
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 that on (b)(6) 2025, a patient presented with grade 4+ functional mitral regurgitation for a mitraclip procedure.A mitraclip xtw was successfully implanted.There was a jet remaining in the medial commissure, a mitraclip nt was selected.After the mitraclip nt was prepared, and successfully advanced it was attempted to be placed.During grasping the grippers would not descend, troubleshooting was performed and after multiple attempts the grippers did response successfully.The mitraclip nt was then implanted successfully.A small flail was identified on the anterior-3/posterior-3 (a3/p3) commissure, which was likely caused by the clip.The final mr was grade 2+.There was no clinically significant delay 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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported gripper actuation issue and tissue injury were unable to be determined.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 23020723
• Report Number: 2135147-2025-05123
• Device Sequence Number: 18519701
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)260518(10)50515A1005
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/17/2025

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: 05/18/2026
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 50515A1005
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 71 KG