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

Model Number	CDS0801-XT
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	07/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 on a patient with thin and friable posterior mitral leaflet, a suspected leaflet cleft at the origin of the mr jet, and a patient who was considered to be high risk for mitraclip procedure.A mitraclip xt was inserted and deployed on the mitral valve.However, post deployment, the clip detached from both leaflets (expulsion) and embolized, and attached to chordae only.It was noted that tissue damage was observed.In the physician¿s opinion, the clip embolized due to poor posterior leaflet integrity.An attempt was made to retrieve the clip but was not successful.Therefore, the clip remained where it was stuck, attached to chordae only, and the procedure was discontinued.The mr remained unchanged.There was clinically significant delay in the procedure due to the tissue injury and clip remaining attached to chordae.It was noted that the patient remained hemodynamically stable throughout the procedure the patient was then transferred to non-intensive care unit (icu) status, and hospitalized.On an unknown date, the patient was reported to have passed away.
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.B2.Date of death is estimated.Pending additional 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 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: 50461319
• Report Number: 2135147-2026-05833
• Device Sequence Number: 10264248
• Product Code: NKM
• UDI-Device Identifier: 05415067050762
• UDI-Public: (01)05415067050762(17)271020(10)60422A1106
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/26/2026

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-XT
• Device Catalogue Number: CDS0801-XT
• Device Lot Number: 60422A1106
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2026
• 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: Death
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Race: Black Or African American