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

Model Number	CDS0706-NT
Medical Device Problem Codes	Break (1069); Material Separation (1562); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.A nt mitraclip was chosen for implantation."+" knob was applied to the steerable guide catheter and both the anterior and medial knobs were applied to the clip delivery system.When making the third grasp attempt, it was noted that the grippers were no longer moving.They were in lowered position and would not raise.Troubleshooting was performed.The clip was able to be removed and a replacement device was implanted without issue.Outside the patient the gripper lines were observed to be detached.There were no patient consequences or clinically significant delay.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
All available information was investigated, and the reported gripper actuation issues and detached gripper lines were confirmed via device 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 did not indicate a lot-specific quality issue.Based on available information and the returned device analysis, the reported gripper actuation issue is a cascading event of the reported detached gripper lines.The investigation evaluated the reported issue, and the engineering group identified the likely root cause to be manufacturing variability at the supplier.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.Codes removed: h6 medical device problem code: 1069 break.Codes added: h6 medical device problem code: 1562 material separation.

• 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: 22078760
• Report Number: 2135147-2025-02730
• Device Sequence Number: 12911589
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)250714(10)40715A1085
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• 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
• Report Date (Section B): 06/25/2025

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: 07/14/2025
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 40715A1085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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: STEERABLE GUIDE CATHETER.
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 70 KG