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

Catalog Number	CDS0701-XTW
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.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.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while in the valve, it was observed that one gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.Two clips were then deployed, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Returned device analysis did not confirm the reported single gripper actuation issue (difficult to open or close).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.A review of the complaint history identified no other complaints from the lot.Based on information provided and the results of the returned device analysis (unable to confirm the reported issue), a cause for the reported difficult to open or close associated with a single gripper actuation issue could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.An xtw clip was prepared per the instructions for use (ifu) and inserted without issues.However, while in the valve, it was observed that one gripper was not functioning as intended.Troubleshooting was performed, but the issue was unable to be resolved.Therefore, the clip was removed and replaced.Two clips were then deployed, reducing mr to a grade of 1.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 21005036
• Report Number: 2135147-2024-06552
• Device Sequence Number: 9839911
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: (01)08717648231001(17)250605(10)40605R1021
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 03/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2025
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 40605R1021
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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
• Patient Sex: Unknown