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

Model Number	CDS0801-NT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/06/2026
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 the information reviewed and without the device available for analysis, the cause of the reported gripper actuation issue could not be determined.The cause of the reported tissue injury appears to be related to user clip manipulation technique/troubleshooting attempts (damage to a heavily calcified leaflet after grasping).Tissue injury, as listed in the mitraclip g5 system, is a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance.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 3 functional mitral regurgitation (mr) and calcified valve for a mitraclip procedure.Imaging was sub-optimal due to patient's complex anatomy.During the procedure, one gripper of the mitraclip nt failed to fully lower and raise during independent gripper actuation.After troubleshooting, the gripper functioned normally; however, the physician elected not to use the device.Following troubleshooting, leaflet damage was noted.As a result, the device was removed from the anatomy.A replacement clip was subsequently utilized to complete the procedure.The mr was reduced to grade 1-2 post procedure.There was no clinically significant delay reported.
Event or Problem Description
It was reported on 06 july 2026 that the patient presented with grade 3 functional mitral regurgitation (mr) and calcified valve for a mitraclip procedure.Imaging was sub-optimal due to patient's complex anatomy.During the procedure, one gripper of the mitraclip nt failed to fully lower and raise during independent gripper actuation.After troubleshooting, the gripper functioned normally; however, the physician elected not to use the device.Following troubleshooting, leaflet damage was noted.As a result, the device was removed from the anatomy.A replacement clip was subsequently utilized to complete the procedure.The mr was reduced to grade 1-2 post procedure.There was no clinically significant delay reported.
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 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: 50083414
• Report Number: 2135147-2026-05186
• Device Sequence Number: 10744209
• Product Code: NKM
• UDI-Device Identifier: 05415067050717
• UDI-Public: (01)05415067050717(17)270804(10)60203A1126
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 08/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CDS0801-NT
• Device Catalogue Number: CDS0801-NT
• Device Lot Number: 60203A1126
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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: Other
• Patient Sex: Unknown