MAUDE Adverse Event Report: ABBOTT MEDICAL MitraClip G4 Clip Delivery System (MDR); Mitral Valve Repair Devices

Model Number	CDS0706-XT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/04/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4+.The patient had a history of heart and organ failure.An xtw clip was successfully implanted.To further reduce mr, an xt clip was deployed.However, after deployment, a jet was observed coming through the anterior leaflet.An abbott pfo closure device was used to treat the jet.Mr was reduced to a grade of <1.There was no clinically significant delay in the procedure.The following morning, the mr remained at <1 and the patient was discharged.On an unknown date, the patient returned to the hospital due to shortness of breath.The physician determined it was due to heart and organ failure.On (b)(6) 2026, the patient passed away.The abbott devices remained stable.
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.

• 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 VASCULAR, Reg # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25659755
• Report Number: 2135147-2026-04454
• Device Sequence Number: 14894264
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260715(10)50715R1025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/16/2026

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: 07/15/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50715R1025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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
• Outcome Attributed to Adverse Event: Other; Death; Hospitalization
• Patient Sex: Unknown