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

Catalog Number CDS0702-XT

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report unintended movement and a gripper actuation issue.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4.It was noted the patient had a dilated heart, enlarged atrium, enlarged ventricle, frail, heart failure, possible hiatus herniation, and tight prominent chordae.Imaging was challenging as well.One clip was successfully implanted, reducing mr to a grade of 3.To further reduce mr, an xt clip was inserted.However, while checking perpendicularity in the left atrium (la), the grippers were down and the physician unknowingly advanced the clip into the left ventricle (lv).While attempting to close the grippers, it was observed the leaflets became caught on the reverse side of the grippers.The clip was inverted and was able to be retracted into the la.Grasping was again performed, but it was observed the anterior leaflet was under the clip arm.While repositioning, the clip became entangled in chordae.Troubleshooting was performed and it was observed that one of the grippers was down and unable to move.The clip was able to be freed from chordae without causing damage.The clip was closed and physician decided to remove the device and discontinue the procedure.Mr remained at a grade of 3.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

In this case, the returned device analysis was unable to confirm the reported bent gripper arm, and also could not replicate the reported difficult or delayed positioning (anatomy) and image resolution poor.The reported ifu deviation could not be replicated in a testing environment as it was related to user technique.The reported gripper arm could not be fully raised and remain lowered as the gripper line was broken.Additionally, there was no bent or other damage observed to the gripper arms.Moreover, the gripper lever latch was found to be missing and a gripper lever cover tab was broken.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.Based on the available information and return device analysis, the cause of the reported image resolution poor is due to patient anatomy.The cause of the reported bent gripper arm cannot be determined.The cause of the reported instructions for use (ifu) deviation was due to physician unknowingly advancing the clip into the left ventricle (lv) when the grippers were lowered, this is considered as a deviation from the instruction for use (ifu).It should be noted that the mitraclip g4 clip delivery system and steerable guide catheter ifu warns ¿always ensure that either the grippers are raised or that the clip is closed while in the lv to avoid potential cardiac injury." the cause of the reported leaflets getting caught on the reverse side of the grippers is a cascading effect of the reported ifu deviation and the reported clip getting entangled in the anatomy is due to manipulation technique.The reported gripper line break appears to be a cascading effect of the reported clip getting entangled in the anatomy.The reported difficulty actuating the gripper is a cascading effect of the gripper line break.The cause of the observed missing gripper lever latch and broken gripper lever cover tabs appear to be post procedural handling of the device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: 2017 code added due to failure to follow steps/instructions.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17182351
• MDR Text Key: 318025419
• Report Number: 2135147-2023-02713
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Catalogue Number: CDS0702-XT
• Device Lot Number: 20802R1052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2022
• 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: IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER