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

Model Number CDS0701-XTW

Device Problems Material Separation (1562); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation has not yet been completed.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is being filed to report gripper actuation issue and gripper line separation.It was reported that the mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with grade 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 but the gripper arm was not responding.Therefore, the cds was removed from the patient anatomy without issue.Outside the patient anatomy, the cds was inspected and it appeared that the gripper line had detached from the gripper arm.Three clips were implanted without issue, reducing mr to 1-2.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 confirmed the reported difficult to open or close.The reported material separation was due to the observed broken gripper line.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history did not identify any similar incidents.Based on the information reviewed, the reported difficult to open or close (gripper actuation) was due to the observed broken gripper line.The reported material separation was due to the observed broken gripper line.A cause for the observed broken gripper line could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 11164114
• MDR Text Key: 226611252
• Report Number: 2024168-2021-00399
• 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: 03/18/2021

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: 08/23/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00822U163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER