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

Model Number	CDS0801-XTW
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026 a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.During the procedure, mitral valve height was 3.25 to 3.5 centimeters.Physician decided to proceed with this height.Once the clip was in position, physician unstraddled the guide to gain the height.This move has caused tear in the anterior leaflet.Intraaortic balloon pump was inserted but was unable to insert due to the small size of the vessel.Procedure was discontinued.All steps were performed as per ifu.Imaging was difficult.The final mr was grade 4.On (b)(6) 2026, it was reported that patient passed away.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 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: 50808280
• Report Number: 2135147-2026-06281
• Device Sequence Number: 10589885
• Product Code: NKM
• UDI-Device Identifier: 05415067050779
• UDI-Public: (01)05415067050779(17)270728(10)60128A1085
• 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
• 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): 09/17/2026

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: 60128A1085
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• 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: Required Intervention; Death
• Patient Sex: Unknown