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

Catalog Number CDS0702-NTW

Device Problems Difficult or Delayed Positioning (1157); Loose or Intermittent Connection (1371); Retraction Problem (1536); Difficult to Open or Close (2921)

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

Event Date 11/08/2023

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 that a patient presented with grade 4 degenerative mitral regurgitation (mr) and leaflet flail for a mitraclip procedure.The clip was inserted into the steerable guide catheter (sgc), where it was noted that the clip introducer did not hold as usual in the hemostasis valve.The clip introducer was not snug to the hemostasis valve.The procedure continued, and the clip was positioned above the valve, where the grippers were tested.One gripper could not lower.Troubleshooting, such as, locking the clip, resulted in the grippe lowering.The clip was then positioned below the valve to catch the leaflets.Unfortunately, the gripper suddenly stopped working again.The anterior leaflet then got caught on the grippers and the clip was unable to be released.After a few attempts and quite some time, the gripper worked again.The clip was able to be freed without damage, and the clip delivery system (cds) was removed from the patient.When pulling the clip back into the clip introducer, the clip got caught.The clip was able to retract into the clip introducer.Unfortunately, when removing the cds from the sgc, it was discovered that the hemostasis valve was drawing air.The sgc was removed and replaced.Additional aspiration was required.There were no adverse patient effects or clinically significant delay.The mr was reduced to grade 1.No additional information was provided.

Manufacturer Narrative

In this case, the returned device analysis confirmed the reported difficult to open or close (gripper actuation single) & loose or intermittent connection (clip introducer).Additionally, the analysis found broken gripper line, clip introducer material was torn, lock line material was frayed, and gripper cover was bulky.However, the reported difficult or delayed positioning (anatomy) could not be replicated.The reported retraction problem (clip introducer) was unable to be determined as the clip introducer was found to be torn.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 the available information and returned device analysis, the cause of the reported loose or intermittent connection (clip introducer) cannot be determined.The cause of the reported gripper actuation issue cannot be determined.The cause of the reported difficult or delayed positioning (anatomy) associated with clip¿s interaction with anatomy appears to be due to the user technique.The observed gripper line break, frayed lock line material, and bulky gripper cover appears to be a cascading effect of the clips interaction with patient anatomy and troubleshooting steps performed to remove the device from the patient.The reported retraction problem (clip introducer) appears to be due to user technique.The reported torn clip introducer is a cascading effect of the reported retraction problem (clip introducer).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: 18233576
• MDR Text Key: 329338996
• Report Number: 2135147-2023-05249
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30620R1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER