MAUDE Adverse Event Report: ABBOTT MEDICAL MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-NTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in the 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.
Event or Problem Description
It was reported that on (b)(6) 2026, a mitraclip procedure was performed to treat mitral regurgitation (mr).A mitraclip was inserted and deployed on the mitral valve, reducing mr.However, an increase in pressure gradient was observed.On an unknown date, post procedure, a transthoracic echocardiogram (tte) revealed moderate to severe stenosis.It was noted that the physician was first notified that a tendyne transcatheter mitral valve replacement was not possible in the first communication regarding this patient.However, the screening revealed a borderline anatomical case that may have been possible for tendyne, and the physician was not notified of this until after the mitraclip procedure, which upset the physician.No additional information was provided.

• Brand Name: MitraClip G5 Delivery System
• 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: 25857871
• Report Number: 2135147-2026-04909
• Device Sequence Number: 5266301
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)270929(10)60401R1001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/13/2026

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 Model Number: CDS0801-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 60401R1001
• 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: 06/22/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Female