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

Catalog Number CDS0702-XTW

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921); Unintended Movement (3026); Physical Resistance/Sticking (4012)

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

Event Date 04/21/2022

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 filed to report the gripper actuation issue and gripper line break.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.One clip delivery system (cds) was advanced and placed above the mitral valve.After diving into the left ventricle (lv) the clip rotated almost 90 degrees and imaging was difficult.The clip was inverted and brought back to the left atrium (la).When diving down to the lv, the anterior leaflet caught on the end of the gripper.The clip was inverted and brought back.The clip was advanced again and the leaflets were grasped.While maneuvering the grippers down it was noted the anterior gripper seemed to not work correctly.The cds was then removed and the gripper line was noted to be broken.The procedure was aborted due to patient anatomy with the mr remaining at 3-4.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported gripper line break and difficult gripper actuation was confirmed via returned device analysis.The reported difficult to remove, image resolution poor, and unintended movement could not be replicated in a testing environment.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 did not indicate a lot-specific quality issue.Based on available information and the results of the analysis, the confirmed difficult gripper actuation was due to the gripper line break.The gripper line break appears to be related to the difficult to remove.The reported difficult to remove was related to procedural circumstances.A cause for the reported unintended movement could not be determined.A cause of the reported image resolution poor could not be determined.There is no indication of a product quality 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: 14338476
• MDR Text Key: 291231293
• Report Number: 2024168-2022-05030
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 11122R143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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