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

Model Number	CDS0706-XT
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
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 did not indicate a lot-specific quality issue.Based on available information, the reported slda was due to pre-existing patient anatomy.The reported difficult imaging was due to procedural circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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 mixed mitral regurgitation (mr) with a grade of 4+, on a patient with restricted anterior leaflet, restricted posterior leaflet, flail, mitral annular calcification (mac), tethering of the anterior leaflet, and prominent chordae.A mitraclip xtw was inserted and deployed on the mitral valve.A second clip, a mitraclip xt was then inserted and deployed on the mitral valve.However, difficulties visualizing the clip occurred, and after deployment of the second clip, the clip detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).It was noted that the slda.No additional clips were implanted, and the clip remained stable.The mr was reduced to a grade of 1+.There were no adverse patient effects and 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: 23380803
• Report Number: 2135147-2025-06082
• Device Sequence Number: 8815680
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: (01)05415067037404(17)260410(10)50411A1107
• 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: 2025
• 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): 11/19/2025

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: 04/10/2026
• Device Model Number: CDS0706-XT
• Device Catalogue Number: CDS0706-XT
• Device Lot Number: 50411A1107
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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
• Patient Age: 86 YR
• Patient Sex: Male