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

Model Number N/A

Device Problems Unstable (1667); Difficult to Open or Close (2921)

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

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated, and the reported clip close inability was confirmed via returned device analysis.In addition, it was observed that the actuator mandrel was protruding from the proximal end, the release crimper was loose, and the collet was cracked.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 incidents reported from this lot.Based on available information, the reported clip close inability was due to the cracked collet tine.The observed protruding actuator mandrel was due to the cracked collet tine.The investigation determined the loose release crimper and the cracked collet to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

Event Description

This is filed to report an unstable/loose release crimper found during device analysis.It was reported that the initial mitraclip procedure was performed on (b)(6) 2022, to treat functional mitral regurgitation (mr) with a grade of 4.During device preparation, the clip was tested by opening and closing the clip by rotating the arm positioner.The lock lever was opened to the blue line and locked after 60 degrees.When completely closing the clip, the clip was not able to close more than 20%.The clip was able to open but not fully close.Multiple attempts were made unsuccessfully and the clip was not used.There was no patient involvement.Another clip was used to complete the procedure with no issues.One clip total was implanted reducing the mr to <1.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 15522766
• MDR Text Key: 306331762
• Report Number: 2135147-2022-01433
• 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
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20131R286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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