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

Model Number CDS0706-NTW

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

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

This is filed to report a break.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and an enlarged atrium.The clip was prepared per the instructions for use (ifu) and had no issues during prep.However, when the clip was inserted into the left atrium (la), it was unable to open.Troubleshooting was performed, but the clip was still unable to open.Therefore, the clip was removed and replaced.One clip was then implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device revealed a broken collet.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported inability to open clip was confirmed via returned device 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.The investigation determined the inability to open the clip appears to be related to the observed slack in the lock line.However, a cause for how the slack became present could not be definitively determined.There is no indication of a product issue with respect 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 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: 16632700
• MDR Text Key: 312287564
• Report Number: 2135147-2023-01387
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037435
• UDI-Public: 05415067037435
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2023
• Device Model Number: CDS0706-NTW
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 21219A1029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 81 YR
• Patient Sex: Male