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

Model Number	CDS0801-XT
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Mitral Valve Stenosis (1965)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4+ functional mitral regurgitation (mr) and a prolapsed posterior leaflet for a mitraclip procedure.During the procedure, a mitraclip was successfully placed on the leaflets.The mean pressure gradient (mpg) increased to 5mmhg.A second mitraclip was then advanced within the patient and placed on the leaflets.The mean pressure gradient increased to 9 mmhg.While removing the clip from the leaflet, it became caught on the anterior leaflet.Troubleshooting was performed unsuccessfully.The clip was able to regrasp the posterior leaflet and was successfully implanted.The procedure was discontinued, the final mr was grade 1 and the mpg was 8mmhg.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: 50161939
• Report Number: 2135147-2026-05340
• Device Sequence Number: 8263100
• Product Code: NKM
• UDI-Device Identifier: 05415067050762
• UDI-Public: (01)05415067050762(17)270615(10)51216R1051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,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 Model Number: CDS0801-XT
• Device Catalogue Number: CDS0801-XT
• Device Lot Number: 51216R1051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• 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
• Patient Sex: Unknown