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

Catalog Number CDS0705-NTW

Device Problems Positioning Failure (1158); Leak/Splash (1354); Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

This is filed to report the mitraclip becoming stuck in the steerable guide catheter and an air leak.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 2-3.The patient presented difficult anatomy due to anterior and posterior mitral annulus being significantly different heights from each other.A ntw mitraclip (lot:30428r1041) was attempted to be implanted utilizing steerable guide catheter (sgc) (lot: 30426r1067).To orient the clip for grasping, the "+" knob on the sgc was added.Multiple attempts at grasping were unsuccessful with the ntw, so it was decided to remove the clip and try a different size.The clip was successfully recaptured by the sgc however, when attempting to remove the clip from the sgc, the clip appeared caught in the chamber of the sgc.The physicians attempted to recapture the clip into the clip introducer, but were unsuccessful.Due to air entering the chamber through the hemostatic valve and the inability to remove the ntw from the sgc, the sgc was brought back to the right side of the heart and the entire system was removed from the patient.No air entered the patient anatomy.A replacement sgc and mitraclips were used to completed the procedure, reducing mr to grade 1.There were no patient consequences or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported positioning failure (leaflet grasping - clip not implanted), retraction problem (clip introducer), and leak / splash could not be replicated in a testing environment.Additionally, the clip introducer was torn, the gripper cover was torn, the actuator coupler was broken, and the harness was deformed.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 observed material split, cut or torn associated with the clip introducer tears, the observed material split, cut or torn associated with the gripper cover tear, the observed break associated with the actuator coupler break, the observed material deformation associated with the harness deformation, and the reported leak / splash associated with the sgc leaking, were due to damage sustained to the clip and sgc hemostasis valve during attempted removal from the sgc.The cause of the reported retraction problem (clip introducer) associated with the inability to withdraw the clip into the clip introducer and so remove from the sgc could not be determined.The reported positioning failure (leaflet grasping - clip not implanted) associated with the grasping inability appear to be due to challenging patient anatomy (unaligned anterior and posterior annuluses).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: 17728290
• MDR Text Key: 323162058
• Report Number: 2135147-2023-03951
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

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 Expiration Date: 04/26/2024
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 30428R1041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 96 KG