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

Catalog Number CDS0701-NTW

Device Problems Break (1069); Difficult to Open or Close (2921)

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

Event Date 08/24/2023

Event Type  malfunction  

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 identified no similar complaints reported from this lot.Based on available information, the reported difficult to open or close (gripper actuation - single) associated with the inability to raise a gripper was due to the gripper line break.The reported break (gripper line - actuation) associated with the gripper line break was identified to be related to a potential product quality issue.This complaint is within the scope of an exception escalation as the complaint description and device code match the specific issue described in the exception, the patient code severity aligns, and the occurrence rate is within the rate specified in the exception.The investigation evaluated the reported issue, and the engineering group identified that determined causes included user technique of gripper actuation, and patient anatomy.Potential causes included variability during manufacturing.Additional actions will be taken if warranted; and will be documented in an exception (action) per internal operating procedures.Abbott will continue to trend the performance of these devices.

Event Description

This is filed to report a gripper lever break.It was reported that during device preparation, all steps were followed per instructions for use (ifu).As functions of the clip were being tested, the gripper line appeared to break when the operator was instructed to "raise the grippers".The suspected gripper arm was laying flat on the clip arm when the gripper lever was in the raised position.After further examination, it was confirmed the gripper lever had snapped.A replacement completed the procedure.There was no patient involvement.No additional information was provided.

• 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: 17765087
• MDR Text Key: 323617846
• Report Number: 2135147-2023-04029
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 20909R1036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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