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

Model Number	CDS0706-XTW
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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), wide central jet and severe-torrential mr for a mitraclip procedure.During the procedure, first mitraclip was implanted on the medial side of anterior and posterior leaflet (a2p2).Second mitraclip was advanced into the left ventricle on the lateral side of the first clip.After successful grasp, it was determined the clip needed to be moved more medial.Grippers were raised and clip was released.During the second grasp, anterior gripper would not lower or raise.Troubleshooting was performed but was unsuccessful.It was decided to remove the clip from the patient but while removing it was observed that the anterior leaflet was caught on the anterior gripper.Implanter rotated the sgc and advanced into the ventricle and was able to remove the stuck leaflet.Cds was removed successfully.Another mitraclip xt was implanted on the lateral side of the first clip.Imaging was difficult.All steps were performed as per ifu.The final mr was grade 3.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.A review of the complaint history identified no similar complaints from the lot.Based on information provided a cause for the reported positioning failure associated with the clip interacting with the anatomy resulting in single gripper actuation issue cannot be determined.Image resolution poor is related to patient and procedural conditions as difficulty visualizing the clip occurred due to shadowing from the guide and short ts height).There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 24470408
• Report Number: 2135147-2026-01214
• Device Sequence Number: 10308920
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)261107(10)51107A1097
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/20/2026

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 Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 51107A1097
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2025
• 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.; STEERABLE GUIDE CATHETER.
• Patient Age: 61 YR
• Patient Sex: Male