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

Catalog Number CDS0702-NTW

Device Problems Product Quality Problem (1506); Difficult to Open or Close (2921)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

This is filed to report a gripper actuation issue.It was reported that a patient presented with grade 3-4 functional mitral regurgitation (mr), an enlarged atrium, and a mr jet in the centro-medial position.During a mitraclip procedure, an ntw was intended to be implanted in the centro-medial position.Successful gripper orientation was performed before advancing in the left ventricle.Both gripper functioned as intended.The clip was in grasping position and both leaflets were able to be grasped.As the grippers were being lowered, it was noted on echocardiogram that the posterior gripper could not lower.The gripper only lowered approximately 30-40 degrees.Troubleshooting was performed, such as locking and unlocking the clip.The issue was not resolved.The ntw was then removed, and replaced with a new clip.The procedure was completed and the mr was reduced to grade 1.After further observation of the ntw clip outside of the anatomy, it was noted that the lock line was wrapped around the grippers.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported difficult to open or close (gripper actuation - single) and product quality problem (irregular appearance) could not be confirmed with returned device 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, the cause of the reported difficult to open or close (gripper actuation - single) and product quality problem (irregular appearance, lock line wrapped around grippers) could not be determined as the issues could not be confirmed through return analysis.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: 17197918
• MDR Text Key: 318206932
• Report Number: 2135147-2023-02738
• 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: 07/25/2023

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: 02/14/2024
• Device Catalogue Number: CDS0702-NTW
• Device Lot Number: 30215R2068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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