MAUDE Adverse Event Report: Abbott Medical MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-NT
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Foreign Body In Patient (2687); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 2-3 mixed mitral regurgitation (mr) for a mitraclip procedure.During the procedure, a mitraclip nt was successfully placed on the leaflets.While opening the clip to regrasp the posterior leaflet, the mandrel of the mitraclip nt detached.The clip was deployed only attached to one leaflet, the clip was not attached to the posterior leaflet.A second mitraclip nt was selected and implanted successfully to stabilize the first clip.The procedure was discontinued, the final mr was grade 3 and the mean pressure gradient (mpg) increased to 7mmhg.There were no clinically significant delays reported.
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 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: 50162016
• Report Number: 2135147-2026-05343
• Device Sequence Number: 8354573
• Product Code: NKM
• UDI-Device Identifier: 05415067050717
• UDI-Public: (01)05415067050717(17)271019(10)60420R1017
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NT
• Device Catalogue Number: CDS0801-NT
• Device Lot Number: 60420R1017
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown