MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. MITRACLIP¿; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0706-XTW
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Altered State of Consciousness (4589)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On [redacted], during right and left heart catheterization performed as part of the pre-surgical evaluation, fluoroscopy demonstrated migration of one mitraclip into the left atrium in a fixed position.Immediately following the procedure, the patient developed altered mental status and right-sided weakness, prompting activation of a stroke alert.Ct imaging of the head demonstrated a migrated approximately 1 cm mitraclip fragment within the basilar artery.The patient's neurological deficits subsequently resolved without intervention, and the patient returned to neurologic baseline.Abbott, the mitraclip manufacturer, was notified of the event.

• Brand Name: MITRACLIP¿
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b east; saint paul MN 55117
• MDR Report Key: 25373846
• Report Number: 25373846
• Device Sequence Number: 13400888
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026
• Report Date (Section F): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 51107A1050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 199 KG
• Date Report Sent to FDA: 05/28/2026