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

Catalog Number CDS0706-XTW

Device Problem Unintended Movement (3026)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

The clip remains in the patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 4.A mitraclip xtw was inserted and deployed on the mitral valve.However, after deployment, the clip did not appear to be completely closed.It was noted that the clip remained stable on the leaflets.The procedure was completed with one clip implanted.The mr was reduced to a grade of 1-2.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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 cause of the reported clip open while locked was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Additionally, this event and the imaging provided by the account were further reviewed by the clinical r&d (research and development) staff engineer, and the reviewer stated that ¿one fluoroscopic still image of the reported device was provided.System curves have been applied to position the clip and the delivery catheter (dc) is partially extended with the clip attached to the l-lock shaft indicating the image was taken prior to deployment (mechanical separation).The clip is in a closed position and the arm angle appears to be ~25° - 30° indicating leaflet grasping and closure on the leaflets was performed, prior to deployment.However, it is unclear at which point in the deployment sequence (e.G., first efaa check, lock line removal, etc.) the image was taken.No post-deployment cine of the reported clip was provided; as such, no assessment or comment can be made regarding the post-deployment state of the clip (clip arm angle after mechanical separation), if and/or by how much the clip opened post-deployment.As such, the reported cowl ("clip did not appear to be completely closed") cannot be confirmed based on the image provided.There are no other observations.¿.

• 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: 18411184
• MDR Text Key: 331590491
• Report Number: 2135147-2023-05760
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: 01/24/2024

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-XTW
• Device Lot Number: 30825A1061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• 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: 73 YR
• Patient Sex: Male