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

Model Number	CDS0706-XTW
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
N/a.
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 the reported clip opening while locked or migration.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The provided imaging was reviewed by an abbott senior associate research fellow.Based on available information, the reported clip opening while locked appears to be related to procedural conditions (user perception).A cause for the reported migration could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
The clip remains in the 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 on (b)(6) 2026 that the patient presented with grade 4 degenerative mitral regurgitation (mr), enlarged atrium and prolapsed leaflet for a mitraclip procedure.During the procedure, the clip opened to 30-40 degree post deployment.Partial clip moment was observed post opening.Another mitraclip was deployed to stabilize the opened clip.Per the physician, steerable guide catheter (sgc) was unable to hold column after removing the first clip.Aspiration resolved the issue.The mr was reduced to grade 1 post procedure.There was no clinically significant delay.

• 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: 24278823
• Report Number: 2135147-2026-00686
• Device Sequence Number: 15934390
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260807(10)50808A1015
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50808A1015
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 96 KG