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

Catalog Number CDS0706-XTW

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, a dilated atrium, and a mean pressure gradient of 2mmhg.It was noted imaging was difficult throughout the procedure.An xtw clip was inserted and advanced under the mitral valve.After multiple grasping attempts, the clip became caught on the anterior leaflet, and was able to be removed.However, it was observed the posterior gripper would not raise.Troubleshooting was performed, but the issue was unable to be resolved.It was noted the posterior gripper line broke, and while grasping, the mean pressure gradient increased to roughly 5-6mmhg.Therefore, the clip was removed, and the procedure was discontinued.After the clip was removed, the gradient returned to baseline.Mr remained at a grade of 4.While outside the anatomy, small pieces of tissue were observed on the clip.There was no clinically significant delay in the procedure.No additional information 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 reported positioning failure (leaflet grasping - clip not implanted) was associated with multiple grasping attempts due to challenging anatomy and difficult imaging.The reported image resolution poor was due to shadowing artifacts.The reported difficult to remove (anatomy), associated with the clip becoming caught on the anterior leaflet, was due to procedural circumstances during leaflet grasping.A cause of the reported broken posterior gripper line could not be determined.The reported difficult to open or close (gripper actuation - single, posterior side) was due to the broken posterior gripper line.The reported tissue injury appears to be related to the clip-to-leaflet interaction.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.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 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: 18370326
• MDR Text Key: 331048559
• Report Number: 2135147-2023-05637
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 21202R1117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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 Outcome(s): Other