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

Model Number	CDS0706-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/20/2026
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 the reported incomplete coaptation.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, a cause for the reported incomplete coaptation- single leaflet device attachment (slda) appears to be related to patient morphology/pathology.The reported recurrent mitral valve insufficiency/ regurgitation (mr) and dyspnea appear to be a cascading effect of the reported slda.Mr and dyspnea are known possible complication associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results 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) 2025, a patient presented with grade 4 functional mitral regurgitation (mr) and thin friable leaflets for a mitraclip procedure.During the procedure, mitraclip xtw was implanted successfully.The final mr was grade 1.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2026, it was determined that a single leaflet device attachment (slda) has occurred and the clip was longer attached to the posterior leaflet.Mr was grade 4 after slda.Patient returned with dyspnea on exertion (doe) and shortness of breath (sob) on (b)(6) 2026, additional mitraclip xt was placed on lateral side of the first clip for stabilization.The final mr was grade 1.

• 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 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: 24586451
• Report Number: 2135147-2026-01566
• Device Sequence Number: 9377747
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: (01)05415067037381(17)260805(10)50801A1082
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 03/12/2026

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: 08/05/2026
• Device Model Number: CDS0706-XTW
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 50801A1082
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown