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

Model Number	CDS0801-NTW
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, it was noticed that the steerable guide catheter was bent when device was removed from the patient.The bend in the guide caused irregular clip maneuvers.Clip had lateral to medial dive despite having no m-knob applied.It was tried to apply l-knob to correct it, which was not effective.The dive was not optimal but manageable to complete the procedure.All steps were performed as per ifu.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, it was noticed that the steerable guide catheter was bent when device was removed from the patient.The bend in the guide caused irregular clip maneuvers.Clip had lateral to medial dive despite having no m-knob applied.It was tried to apply l-knob to correct it, which was not effective.The dive was not optimal but manageable to complete the procedure.All steps were performed as per ifu.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.
Additional Manufacturer Narrative
The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on information provided and without the device to analyze, the cause for the reported unintended movement associated with clip movement could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 24839349
• Report Number: 2135147-2026-02311
• Device Sequence Number: 9594138
• Product Code: NKM
• UDI-Device Identifier: 05415067050748
• UDI-Public: (01)05415067050748(17)261001(10)50403R1096
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/19/2026

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 Expiration Date: 10/01/2026
• Device Model Number: CDS0801-NTW
• Device Catalogue Number: CDS0801-NTW
• Device Lot Number: 50403R1096
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: 1XMITRACLIP
• Patient Age: 78 YR
• Patient Sex: Male