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

Catalog Number CDS0706-NTW

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

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

Event Date 12/06/2023

Event Type  malfunction  

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.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+ and a posterior prolapse.It was noted imaging was challenging throughout the procedure.An ntw clip was inserted and advanced under the mitral valve.It was noted multiple positioning and grasping attempts were performed; to achieve a better mr reduction, and due to the clip arms not being long enough to grasp the posterior prolapse.However, while grasping the leaflets and actuating both grippers, it was observed the anterior gripper would not lower.Initially, the grippers were able to actuate, but after multiple attempts, the anterior gripper stopped lowering.Troubleshooting was performed while in the left atrium (la), but the issue was unable to be resolved.Therefore, the clip was removed and while outside the anatomy, it was observed the anterior gripper line was detached from the gripper.The procedure was discontinued, and mr remained at a grade of 4+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

In this case, the reported image resolution poor, and positioning failure could not be replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.It was also observed that a gripper line broke causing inability to raise the gripper.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 cause of the reported poor image resolution appears to be due to procedural conditions.The reported inability to position the clip over leaflets and grasp them appears to be due to a combination poor image resolution and wrong size clip selection.The cause of the reported inability to lower the gripper cannot be determined.The cause of the reported broken gripper line appears to be due to troubleshooting steps performed during the procedure.The inability to raise gripper during returned device analysis is due to the reported broken gripper line.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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 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: 18410958
• MDR Text Key: 331683615
• Report Number: 2135147-2023-05753
• 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,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-NTW
• Device Lot Number: 30801A1015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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