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); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported unable to open clip and premature activation were unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported on (b)(6) 2026, that the patient presented with grade 4+ functional mitral regurgitation (mr) and restricted posterior leaflet for a mitraclip procedure.During the procedure, the steerable guide catheter (sgc) was advanced into the left atrium, followed by advancement of the clip.After advancement, an attempt was made to open the clip; however, the clip failed to open despite troubleshooting maneuvers.As a result, an attempt was made to remove the clip from the anatomy.During this process, it was noted that the clip had detached from the clip delivery system (cds).A snare was utilized to retrieve the clip, followed by balloon dilation of the septum to facilitate withdrawal of the snared clip into a non-abbott sheath.The clip was successfully removed from the anatomy.During preparation of second clip, the clip was unable to pass establish final arm angle test (efaa) as the clip jumped open to 120 degree.The clip was replaced with another device to complete the procedure.The mr was reduced to grade <1 post procedure.There was no clinically significant delay 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 VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25430968
• Report Number: 2135147-2026-03854
• Device Sequence Number: 13309241
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)270115(10)50718R1020
• 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
• 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): 06/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 50718R1020
• 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: 05/14/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown