MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Model Number	CDS0706-NT
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.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 a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 on a patient with friable tissue a mitraclip nt was inserted and deployed on the mitral valve.To further reduce mr, a second clip, a mitraclip nt, was then inserted and grasping was performed.A good grasp and captured was achieved.However, prior to deployment, a transthoracic echocardiogram (tte) was performed and revealed that the anterior mitral leaflet (aml) had slipped out of the clip, that the mr had increased, and the aml was observed to be damaged.Therefore, the clip was repositioned and deployed closer to the first implanted clip.No additional clips were implanted, and the mr remained at a grade of 4.The clips were noted to be stable on the leaflets.There were no clinically significant delay in the procedure.
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, the reported difficult or delayed positioning (loss of leaflet capture) appears to be related to patient morphology/pathology.The reported patient effect of tissue injury appears to be a cascading effect of the reported loss of leaflet capture due to morphology/pathology.The unchanged mr appears to be due to the tissue injury.Tissue injury and mr are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case specific circumstance as intervention was performed.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4 on a patient with friable tissue a mitraclip nt was inserted and deployed on the mitral valve.To further reduce mr, a second clip, a mitraclip nt, was then inserted and grasping was performed.A good grasp and captured was achieved.However, prior to deployment, a transthoracic echocardiogram (tte) was performed and revealed that the anterior mitral leaflet (aml) had slipped out of the clip, that the mr had increased, and the aml was observed to be damaged.Therefore, the clip was repositioned and deployed closer to the first implanted clip.No additional clips were implanted, and the mr remained at a grade of 4.The clips were noted to be stable on the leaflets.There were no clinically significant delay in the procedure.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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 ; 6517565400
• MDR Report Key: 24335482
• Report Number: 2135147-2026-00896
• Device Sequence Number: 9790577
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: (01)05415067037367(17)260518(10)50515A1047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/05/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2026
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 50515A1047
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown