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

Model Number CDS0706-NTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a gripper line break, causing a gripper actuation issue.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade of 4.The first clip (xtw) was implanted with no reported issue.An ntw clip was advanced to the mitral valve.It was noted that one of the grippers would not drop.The grippers were cycled a few times and the gripper started working.On the third grasping attempt, the anterior gripper stopped dropping.It was noted that there was difficulty capturing the leaflets.The clip arms were closed, capturing both leaflets.The clip was implanted and stable on both leaflets.Mr was reduced to grade 3.It seems that the gripper line broke, which caused the anterior gripper not to drop.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

In this case, the reported difficult to open or close associated with single gripper actuation issue and gripper line break could not be replicated in a testing environment due to the returned condition of the device (clip was implanted and therefore was not returned).The reported difficult or delayed positioning associated with leaflet capture could not be replicated in a testing environment due to procedural/operational circumstances.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 other complaints from the lot.Based on the results of the analysis and the information provided, a cause for the reported single gripper actuation issue resulting in the difficulty capturing the leaflets (difficult or delayed positioning) cannot be determined.The gripper line break appears to be related to the user¿s perception for the cause of the single gripper actuation issue.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 MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16777017
• MDR Text Key: 313720401
• Report Number: 2135147-2023-01724
• 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,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30208A1023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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: 1 IMPLANTED MITRACLIP.; STEERABLE GUIDE CATHETER.
• Patient Age: 63 YR
• Patient Sex: Female