MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G5 DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	CDS0801-NTW
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	04/14/2026
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 positioning failure (leaflet grasping) and tissue injury were unable to be determined.The reported worsening mr seems to be related to the reported tissue injury.The reported patient effects of tissue injury and mitral regurgitation, as listed in the mitraclip g5 system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment 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 that on (b)(6) 2026, a patient presented with grade 3-4 mitral regurgitation (mr) for a mitraclip procedure.During the procedure, there was challenges grasping the leaflets.Troubleshooting was performed, and the leaflet was torn.The clip was attempted to be placed; there was no change in mr so the clip was removed from the patient.The procedure was discontinued, the final mr remained at grade 2-4.There were no clinically significant delays 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: 25143888
• Report Number: 2135147-2026-03140
• Device Sequence Number: 21163481
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)261217(10)50618R1018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/11/2026

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: 50618R1018
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown