MAUDE Adverse Event Report: ABBOTT MEDICAL MitraClip G5 Delivery System; mitral valve repair devices

Model Number	CDS0801-NTW
Medical Device Problem Codes	Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
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 on (b)(6) 2026 that the patient presented with grade 4 functional mitral regurgitation (mr), a dilated left atrium, and restricted, calcified leaflets for a mitraclip procedure.Imaging was sub-optimal due to patient's complex anatomy.During the procedure, a mitraclip was successfully implanted.Post deployment, the clip had single leaflet device attachment (slda) from the anterior leaflet.Another mitraclip ntw was prepared for deployment to stabilize the slda clip.During preparation, the release pin was prematurely pulled, and upon testing the clip arms, the device was unable to open.As a result, a mitraclip nt was opened; however, during preparation, the clip was also unable to open following raising the grippers and unlocking of the clip.Subsequently, a mitraclip xtw was deployed to stabilize the slda clip.Anterior leaflet was observed to be damaged post slda.Post-procedure, the mr was reduced to grade 2.There was no clinically significant delay or adverse patient effects reported.

• 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: 25621424
• Report Number: 2135147-2026-04341
• Device Sequence Number: 13316520
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 51104A1067
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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.
• Patient Age: 70 YR
• Patient Sex: Female