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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4, prolapsed leaflet, flail, and friable leaflet.A mitraclip xtw was inserted and advanced into the left ventricle (lv).Two hours were spent attempting to secure a good grasp on the leaflets.The leaflets were ultimately grasped, but after closing the clip, a tear occurred.Leaflet tissue damage was suspected due to the multiple grasps.The clip then became caught in the posterior leaflet and the chordae was entangled with the gripper.To free the clip from chordae, troubleshooting was performed.To free the clip from the chordae, the grippers were cycled several times.Fluoroscopy was performed and it was observed that the posterior gripper was not functioning as intended.The mitraclip system was removed from the patient.While outside the patient body, the device was examined and confirmed that the posterior gripper was not functioning as intended and the gripper line was observed to have been broken.It was noted that the posterior gripper line had broken after cycling the grippers multiple times in the attempt to free the clip from the posterior leaflet and chordae.Difficulties visualizing the clip during the procedure occurred.The case was aborted with no clips implanted.The mr remained at a grade of 4.On the same day, the patient underwent mitral valve surgery without complications.

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6: device code 2017 - failure to follow steps / instructions.

Manufacturer Narrative

The device was not returned for analysis.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.The investigation determined the reported inability to grasp and poor image resolution appear to be related to patient morphology/pathology.The reported clip became caught on the posterior leaflet and the chordae was entangled with the gripper (difficult to remove) was due to multiple grasping attempts.The gripper line break was due to cycling the grippers multiple times in the attempt to free the clip from the posterior leaflet and chordae.The gripper actuation issue was a result of to the broken gripper line.The reported improper or incorrect procedure or method was due to the user error of curving the clip delivery system (cds) more than 90 degrees.The tissue damage appears to be due to multiple grasps.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention were results of case specific circumstances as the patient remained hospitalized and a mitral valve surgery was performed.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 18379384
• MDR Text Key: 331174983
• Report Number: 2135147-2023-05692
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 30821A1069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention