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

Model Number N/A

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Difficult to Open or Close (2921)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

This is filed to report the leaflet becoming caught on the gripper, the gripper actuation issue and the gripper line breaking.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4.It was noted that the patient had scar tissue at the fossa puncture site.The steerable guide catheter (sgc) (20216r505) was inserted in the patient, however the device could not advance as intended.The sgc was removed and a balloon was used to dilate the transseptal puncture.The sgc was inserted again but still could not advance properly through the septum.The device was removed and it was noted that the sgc soft tip was damaged due to the anatomy.A replacement sgc was then prepared per the instructions for use (ifu) and was able to be used normally.A mitraclip xtw (1102r279) was advanced in the patient and there were several attempts to grip the leaflets but it could not capture.The grippers were cycled and re-tried but several interactions with the anterior leaflet occurred, as the leaflet was getting stuck on the grippers.Minor maneuvers and two inversions were done to get the leaflet off but it was then noted that the gripper arm on the anterior leaflet was no longer dropping, and there was no gripper line visible.The clip was removed without issue.A replacement mitraclip xtw was used to complete the procedure, successfully reducing the mr to grade 1.The clip with gripper issue was dissembled and measured on the test bench to determine if any part of the gripper line had been left in the patient.It was determined there was nothing left in the patient.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional steerable guide catheter referenced in the event will be filed under a separate medwatch report number.

Manufacturer Narrative

An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15336819
• MDR Text Key: 302801661
• Report Number: 2135147-2022-00970
• 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: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 11102R279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 95 KG