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

Model Number	CDS0601-NTR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.After the transseptal puncture was performed, it was noticed that the atrial septum was damaged due to the large sheath passing through it.Ventricular fibrillation and tamponade were noted after the perforation and pericardiocentesis was performed.One clip was prepared and advanced, however, in the process of attempting to grasp and capture the leaflets, a leaflet tear was observed.Mr increased to 4+.The clip was removed and the procedure was abandoned.Mitral valve replacement surgery was performed after removal of the clip.
Event or Problem Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.After the transseptal puncture was performed, it was noticed that the atrial septum was damaged due to the large sheath passing through it.Ventricular fibrillation and tamponade were noted after the perforation and pericardiocentesis was performed.One clip was prepared and advanced, however, in the process of attempting to grasp and capture the leaflets, a leaflet tear was observed.Mr increased to 4+.The clip was removed and the procedure was abandoned.Mitral valve replacement surgery was performed after removal of the clip.
Additional Manufacturer Narrative
In this case, there was no functional testing for the returned device as no device malfunction was reported.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation determined the reported tissue injury appears to be related to procedural conditions.The reported worsening mr appears to be due to the tissue injury.Tissue injury and mr are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization and surgical intervention were results of case specific circumstances as the patient remained hospitalized and mitral valve replacement surgery was performed.There is no indication of a product 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: 21619863
• Report Number: 2135147-2025-01327
• Device Sequence Number: 18271636
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: (01)08717648226342(17)250909(10)40905R2039
• 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,Followup
• Report Date (Section B): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2025
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 40905R2039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Sex: Unknown