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

Model Number	CDS0706-NTW
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	10/08/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 and a mean pressure gradient of 2mmhg.Two mitraclip ntw clips were inserted and deployed on the mitral valve.A third clip, a mitraclip ntw, was then inserted and grasping was performed.However, the clip became caught in chordae.Troubleshooting was performed, and the clip was able to be removed from the chordae.However, while bringing the clip back into the atrium, imaging revealed a chordal rupture.The clip was then brought back into the valve, and grasping was performed.The clip was then deployed on the mitral valve.However, the mr was unable to be reduced, and the gradient had increased to 10mmhg.No additional clips were implanted due to the gradient.There was no clinically significant delay in the procedure.However, post procedure, on the same date, the patient passed away.
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.
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 remove (anatomy) or poor image resolution.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The narrative was reviewed by an abbott senior director of medical affairs.Based on available information, the reported difficult removal from anatomy appears to be related to procedural conditions (poor imaging, clip caught during positioning).The reported poor imaging is related to procedural conditions (device shadowing), per case details.The reported mitral regurgitation and tissue injury appear to be cascading events of the troubleshooting performed for the difficult removal from anatomy.A cause for the reported mitral stenosis could not be conclusively determined.A cause for the reported death could not be conclusively determined.The reported patient effects of mitral regurgitation, tissue injury, mitral stenosis, and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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: 23423931
• Report Number: 2135147-2025-06202
• Device Sequence Number: 9863977
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: (01)05415067037435(17)260428(10)50429A1014
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/15/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 50429A1014
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• 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: 2 IMPLANTED MITRACLIPS.; STEERABLE GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 79 YR
• Patient Sex: Male