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

Model Number	CDS0706-XTW
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.However, 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) 2026 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, resistance was noted during removal of the lock line.At that time, only one end of the lock line was accessible, and traction was applied until partial withdrawal of the line was achieved.A knot was observed while removal attempts were made.The lock line subsequently became restricted again and could not be further removed.A decision was made to apply tension to the lock line while attempting to open the clip.This maneuver resulted in unlocking of the clip.The clip was successfully opened and inverted for retraction into the left atrium.The clip was then removed from the anatomy, and a replacement clip was utilized to complete the procedure.The mr was reduced to grade 1 post procedure.There was no clinically significant delay or adverse patient effects reported.
Event or Problem Description
It was reported on (b)(6) 2026 that the patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, resistance was noted during removal of the lock line.At that time, only one end of the lock line was accessible, and traction was applied until partial withdrawal of the line was achieved.A knot was observed while removal attempts were made.The lock line subsequently became restricted again and could not be further removed.A decision was made to apply tension to the lock line while attempting to open the clip.This maneuver resulted in unlocking of the clip.The clip was successfully opened and inverted for retraction into the left atrium.The clip was then removed from the anatomy, and a replacement clip was utilized to complete the procedure.The mr was reduced to grade 1 post procedure.There was no clinically significant delay or adverse patient effects reported.
Additional Manufacturer Narrative
All available information was investigated, and the reported knotted and jammed lock line were confirmed via device analysis.Additionally, the clip cover was observed to be torn.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 and the returned device analysis, the cause of the reported knotted lock line and torn clip cover were unable to be determined.The reported jammed lock line was a result of the reported knotted lock line.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: 25350976
• Report Number: 2135147-2026-03704
• Device Sequence Number: 18717724
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260806(10)50731A1051
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/17/2026

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: 08/06/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50731A1051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 80 KG