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

Model Number	CDS0801-XTW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	07/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with degenerative mitral regurgitation (mr) and an anterior 2/3 leaflet flail for a mitraclip procedure.During the procedure, a mitraclip was successfully implanted on the anterior-3/posterior-3 (a3/p3) leaflets.The patient went into cardiogenic shock, a balloon pump was successfully placed and the patient was stabilized.During preparation of the second mitraclip, it was identified during the lock check that the clip would not open.Troubleshooting was performed unsuccessfully.The procedure was discontinued, the final mr was reduced.The patient was admitted to the hospital for monitoring.There were no clinically significant delays reported.It was reported that during the following weekend, (b)(6) 2026, the patient was declared dead while in the icu.No additional information was provided.
Additional Manufacturer Narrative
The device is not returning 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: 50461489
• Report Number: 2135147-2026-05835
• Device Sequence Number: 16012760
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• UDI-Public: (01)05415067050779(17)270708(10)60107R1046
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0801-XTW
• Device Catalogue Number: CDS0801-XTW
• Device Lot Number: 60107R1046
• 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: 01/08/2026
• 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: 88 YR
• Patient Sex: Male