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

Model Number CDS0701-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Open or Close (2921)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.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 gripper line break it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.A flail and rotated heart were present, resulting in difficult imaging.An xtw clip was inserted, and grasping was performed.However, due to the difficult imaging, the leaflets were difficult to grasp.It was then observed the clip became caught in the lateral commissure.Troubleshooting was performed and the clip was removed from the commissure without causing damage.The clip was retracted into the left atrium (la) and repositioned.Grasping was again attempted, but it was observed the anterior gripper was not lowering.The clip was again retracted in the la and troubleshooting was performed.However, the gripper was still unable to lower.Therefore, the clip delivery system (cds) was removed.Upon removal, it was observed the gripper line to the anterior gripper had detached and was retracted into the cds shaft.Due to the difficult imaging, the physician decided to discontinue the procedure.Mr remained at a grade of 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.During returned device analysis, the reported broken gripper line and inability to raise a single gripper arm were confirmed.The reported poor imaging, failure to grasp leaflets, and clip caught in anatomy could not be replicated in a testing environment.Based on all available information, the reported failure to grasp leaflets appears to be due to a combination of challenging patient anatomy and procedural conditions.The reported clip caught in anatomy appears to be a cascading event of the failure to grasp leaflets.The broken gripper line appears to be a cascading event of the clip caught in anatomy.The difficult single gripper actuation is a cascading event of the broken gripper line.The reported poor imaging is due to challenging patient anatomy.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13763596
• MDR Text Key: 287266034
• Report Number: 2024168-2022-02640
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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: Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10421R181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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