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

Model Number	CDS0701-XTW
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
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.The investigation determines that the reported migration appears to be related pre-existing patient anatomy.The reported mitral regurgitation (mr) is a cascading event of the migration.Tissue injury appears to be related to partial clip movement.Dyspnea appears to be a cascading effect of the recurrent mr.The reported patient effect of mitral valve regurgitation, dyspnea, and fatigue are known possible complication associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4 on a patient with a pre-existing flail and friable leaflets.A mitraclip xtw was implanted, reducing mr to a grade of 2-3.On (b)(6) 2026, the patient returned to the hospital with symptoms of shortness of breath.An echocardiogram was performed and revealed that the clip had partially detached from the posterior leaflet and remained fully attached to the anterior leaflet (partial clip movement), causing mr to increase to a grade of 4.It was noted that the new issue was attributed to deterioration of leaflet quality, and that the flail had gotten worse since the first procedure.A second mitraclip procedure was performed, and two clips were implanted, reducing mr to a grade of 1-2.

• Brand Name: MITRACLIP
• 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: 24866631
• Report Number: 2135147-2026-02405
• Device Sequence Number: 10550027
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)240108(10)30109R1003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 01/08/2024
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 30109R1003
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2023
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male