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

Model Number CDS0701-XTW

Device Problems Difficult to Remove (1528); Unstable (1667); Difficult to Open or Close (2921); Material Deformation (2976)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned.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 actuation issue and material deformation it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The clip was inserted and advanced into the left ventricle (lv).It was noted that prior to grasping, the anterior leaflet became caught on the shaft just above the anterior gripper but was able to be easily removed.Grasping was then performed.However, while lowering the grippers, it was observed that there was a slight delay in the anterior gripper when lowered.The clip was able to be completely closed, but it was observed that the anterior gripper was facing in a slight diagonal direction.Due to this, the physician opened the clip and retracted it back into the left atrium (la).The clip was closed, and it was again observed the gripper was not even with the clip arm.Therefore, the clip was removed and replaced.Once outside the anatomy, the physician stated that the gripper line associated with the anterior gripper felt looser then the other one.A new clip was then inserted and successfully deployed, reducing mr to a grade of 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The returned device analysis did not confirm the reported gripper actuation issue, unstable grippers and material deformation issue.The reported difficult to remove could not be replicated in a testing environment as it was related to patient/procedural conditions or 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 similar incident reported from this lot.Based on available information, the reported difficult to remove appear to be due to procedural circumstances.A cause for the reported gripper actuation, unstable grippers and material deformation issue cannot 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: 12228059
• MDR Text Key: 263542484
• Report Number: 2024168-2021-06483
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10423R180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Age: 76 YR
• Patient Weight: 82