MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

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 Description

This is being filed to report gripper actuation issue.It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) with grade of 4.The clip delivery system (cds) was advanced to the mitral valve and grasping was performed.However, one of the gripper arms did not go down.Troubleshooting was performed such as cycling the lock lever and re-closing the clip but the gripper arm did not come down.Therefore, the physician decided to invert the clip and remove the cds.A new cds was used to complete the procedure.One clip was implanted, reducing mr to 1.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis could not confirm the reported difficult to open or close (gripper actuation) as both grippers were able to lower and raise as intended without issue.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot which could have contributed to the reported issues.Additionally, a review of the complaint history did not identify a lot specific issue.Based on the information reviewed, a cause for the reported difficult to open or close (gripper actuation) could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11177564
• MDR Text Key: 227045128
• Report Number: 2024168-2021-00478
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 09/20/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00921U123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1