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

Catalog Number CDS0705-XTW

Device Problem Difficult to Open or Close (2921)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 mixed mitral regurgitation (mr) for a mitraclip procedure.During use of the first clip, the anterior gripper could not be lowered.The gripper lowered for the first capture attempt, and was raised and could not lower with the second attempt.The clip was locked and standard troubleshooting was performed.The gripper could not lower, so the clip was removed and replaced with new one.During post-procedure handling, it was noticed that the gripper would not lower from the shaft.The physician manually pulled on the stuck gripper and it lowered.Once freed manually it worked intermittently but not normally (continued to get stuck).All steps were followed per instructions for use (ifu) and no other incidents occurred.The procedure was completed successfully with a mr grade of 1.There were no adverse patient effects or clinically significant delay.

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 and without the device to analyze, a cause of the reported difficult to open or close (gripper actuation - single) could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18488963
• MDR Text Key: 332653569
• Report Number: 2135147-2024-00185
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2024

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: CDS0705-XTW
• Device Lot Number: 30731R1040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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