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

Catalog Number CDS0705-XTW

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

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 mixed mitral regurgitation (mr) with a grade of 4+, an anterior prolapse, and a dilated left atrium.An xtw clip was inserted and advanced under the mitral valve.However, one of the grippers became caught on the anterior leaflet.Troubleshooting maneuvers were performed, and the clip was able to be removed.However, it was observed one of the gripper lines was broken.Therefore, the clip was removed from the anatomy and replaced.The procedure was continued, and two new clips were successfully implanted, reducing mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.

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 did not indicate a lot-specific quality issue.Based on available information, the cause of the reported difficult positioning (anatomy) was unable to be determined.The reported broken gripper line was likely due to troubleshooting the clip being caught in anatomy.The reported difficult to open clip and clip jumping were cascading events of the reported improper or incorrect procedure or method.The reported difficult imaging was due to the challenging patient anatomy.The reported improper or incorrect procedure or method was associated with the user not pulling the lock lever until the blue line was visible.It should be noted that the mitraclip instructions for use (ifu) states, "rotate the lock lever outward and then retract the lever until the mark on the lever is fully exposed." 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 initially filed report, additional information was received stating that imaging was challenging throughout the procedure.It was noted during positioning, the clip had difficulty opening as the lock lever was not fully withdrawn to the blue line.After fully retracting the lock lever, the clip arms jumped open.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• 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: 18622999
• MDR Text Key: 334498608
• Report Number: 2135147-2024-00446
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-XTW
• Device Lot Number: 30925R2049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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