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

Model Number	CDS0601-XTR
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.During the procedure, two mitraclips were implanted successfully.The procedure was discontinued, the final mr was reduced to grade 1.There were no adverse patient effects or clinically significant delays reported.It was reported that on (b)(6) 2026, a follow-up echocardiogram was performed and it was identified that the patients mr had increased to grade 3.The patient was transitioned into a procedure for a secondary mitraclip procedure.During the procedure, it was identified that one of the previously implanted clip had a single leaflet detachment (slda) and was no longer attached to the anterior leaflet.An additional clip was implanted beside the slda clip for stabilization.The procedure was discontinued, the final mr was reduced to grade 1.There were no adverse patient effects or clinically significant delays reported.
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 the available information, a definitive cause for the reported single leaflet device attachment (slda) could not be determined.The reported increase in mr appears to be a cascading effect of the slda.Mitral regurgitation, as listed in the mitraclip system instructions for use, is a known potential complication associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were the result of case-specific clinical circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 25382848
• Report Number: 2135147-2026-03756
• Device Sequence Number: 18507419
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: (01)08717648226366(17)270123(10)60122R1088
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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 Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 60122R1088
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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; Required Intervention; Hospitalization
• Patient Sex: Unknown