MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-NT

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Open or Close (2921)

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

Event Date 02/02/2022

Event Type  Injury  

Event Description

This is filed to report device entrapment, a shaft break and a gripper actuation issue it was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.A posterior prolapse was present and there was less than optimal height above the valve.Two clips were deployed on the mitral valve, reducing mr to a grade of 3.To further reduce mr, a third clip was inserted and advanced into the left ventricle (lv).While in the lv, the physician decided to slightly change the orientation of the clip, which caused the clip to be come caught in the chordae.This resulted in a clinically significant delay in the procedure.While attempting to remove the clip from the chordae, a lot of stress was applied to the system, which caused the clip delivery system shaft (cds) to break.The grippers were also unable to lower as it was observed the chordae was wrapped around the grippers and the cds shaft.Since the cds was unable to be removed, the clip had to be surgically removed.Mitral valve replacement was then performed.No additional information was provided.

Manufacturer Narrative

The device is retained by hospital and not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event and a review of the complaint history identified no lot-specific product quality issue from this lot.Based on available information, the reported entrapment of the device appears to be due to the user technique.The reported break appears to have resulted from procedural circumstances.The reported gripper actuation issue was a cascading event of reported entrapment of the device.Lastly, the reported removal of foreign body, surgical intervention, delay to treatment/ therapy and hospitalization were a result of cases specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13581594
• MDR Text Key: 286647312
• Report Number: 2024168-2022-01878
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2022
• Device Catalogue Number: CDS0702-NT
• Device Lot Number: 10315R153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Disability; Hospitalization; Required Intervention