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

Model Number CDS0706-NT

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

This will be filed to report a gripper actuation issue and broken gripper line.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+ with restricted leaflets.An nt clip was inserted into the left atrium (la) and the grippers were independently actuated.However, one of the grippers was not lowering.Troubleshooting was performed and it was believed the gripper line had broken.Therefore, the clip was removed and replaced.One clip was successfully implanted, reducing mr to a grade of 1+.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (gripper actuation - single) and break (gripper line - actuation) were confirmed via returned device analysis.The reported image resolution poor and improper or incorrect procedure or method during procedure could not be replicated in a testing environment.Additionally, the l-lock tabs were observed to be broken.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, a cause of the reported single gripper actuation issue (unable to lower) could not be determined.A cause of the broken gripper line also could not be determined.The reported image resolution poor was associated with difficult imaging.A cause of the observed broken l-lock tabs could not be determined.The reported improper or incorrect procedure or method was associated with the user handling the clip implant directly.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: device code 2017 - failure to follow steps / instructions.

Event Description

Subsequent to the previously reported information, it was further reported that the clip was handled directly against instructions for use.No additional information was provided.

• 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 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: 16902736
• MDR Text Key: 314920083
• Report Number: 2135147-2023-02021
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037367
• UDI-Public: 05415067037367
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: CDS0706-NT
• Device Catalogue Number: CDS0706-NT
• Device Lot Number: 30227R1037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 80 KG