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

Model Number	CDS0706-NT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.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+ degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, two mitraclips were successfully implanted before the procedure was discontinued.The final mr remained unchanged at grade 4+.There were no clinically significant delays reported.On (b)(6) 2025, the patient returned for open heart surgery to treat the high mr through a mitral valve replacement procedure.The procedure was successful and the mr was reduced.
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4+ degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, two mitraclips were successfully implanted before the procedure was discontinued.The final mr remained unchanged at grade 4+.There were no clinically significant delays reported.On (b)(6) 2025, the patient returned for open heart surgery to treat the high mr through a mitral valve replacement procedure.The procedure was successful and the mr was reduced.On (b)(6) 2026: this file (b)(4) - (b)(6) has been identified as a duplicate, as the part and lot number were identical in addition to the reported event details to (b)(4) - (b)(6).All pertinent and additional information will be added to (b)(4).
Additional Manufacturer Narrative
(b)(6) has been identified as a duplicate, as the part and lot number were identical in addition to the reported event details to (b)(4) - (b)(6).Codes removed: health effect-clinical code: 4451.Health effect- impact code: 4607;4624.

• 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: 23662841
• Report Number: 2135147-2025-07022
• Device Sequence Number: 15734320
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)250319(10)40319A1042
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/06/2026

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: 03/19/2025
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 40319A1042
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2024
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown