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

Model Number	CDS0801-XTW
Medical Device Problem Codes	Premature Activation (1484); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.However, 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 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4-5 on a patient with a small atrium.A steerable guide catheter (sgc) was prepared per the instructions for use (ifu) and successfully crossed the septum.A mitraclip xtw clip delivery system (cds) was prepared and inserted.However, when the clip was inserted into the left atrium (la), it was unable to open.Troubleshooting was performed, but the clip was still unable to open.Therefore, a decision was made to remove and replace the clip.However, as the cds was retracted into the sgc, it appeared unstable; it appeared that it was not well attached to the mandrel, and every movement made, the clip would turn off the mandrel until the clip was perpendicular to the sgc.A snare was then inserted to retrieve the clip.However, the clip was unable to be retrieved, and remained inside the patient, attached to the septum.There was no clinically significant delay in the procedure.The patient was reported to be stable.

• 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 Medical Northpoint Reg 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50919991
• Report Number: 2135147-2026-06578
• Device Sequence Number: 12104866
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 09/28/2026

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-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60423A3005
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown