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

Catalog Number CDS0706-NTW

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, annulus calcification, and a short, restricted, thin, and calcified posterior leaflet.During preparation while testing an ntw clip (30413r1103), one of the grippers would not lower.Troubleshooting was performed, including locking and unlocking the clip.It was noted when the clip was locked the one gripper would lower.Therefore, the clip was not used and replaced.A new ntw clip (30414r1015) was inserted.However, the clip was unable to grasp and capture the posterior leaflet.Therefore, the clip was removed, and the procedure was discontinued.Tissue damage to the posterior leaflet was observed.Mr remained at a grade of 4.There was no clinically significant delay in the procedure.

Manufacturer Narrative

All available information was investigated and the reported gripper actuation issue was not confirmed via returned device 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 was unable to determine a cause for the reported gripper actuation issue.There is no indication of a product issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: 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: 18579866
• MDR Text Key: 333823168
• Report Number: 2135147-2024-00351
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30413R1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG