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

Catalog Number CDS0705-NTW

Device Problems Product Quality Problem (1506); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This is filed to report gripper actuation.It was reported that this was a mitraclip procedure to treat functional mitral degenerative regurgitation (mr) with a grade of 4.It was noted thin leaflets.The clip delivery system (cds) was advanced to the mitral valve; however, after the cds was positioned in the left atrium, the gripper arm would not fully lower.Troubleshooting was performed, but failed.Therefore, a decision was made to remove the cds from the patient.After cds removal, the grippers were inspected, and it was observed that the gripper line was caught in the reflection element.It was noted that there was no resistance when pushing the gripper lever forward.The procedure continued with a new clip.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

N/a.

Manufacturer Narrative

The returned device analysis confirmed the reported difficult gripper actuation as one of the gripper arms was initially unable to lower as the gripper cover was caught in the harness.After the lock lever was advanced to lock the clip, the harness released the gripper cover and the gripper arm could then be lowered.The observed problem was due to the gripper cover getting caught in the harness.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported lot.Additionally, a review of the complaint history did not identify a lot specific issue.Based on the information reviewed, a potential product issue was identified due to the observed product quality problem resulting in the single gripper actuation issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D6a: implant date removed.H6: device code 2906 removed.

• 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
• MDR Report Key: 11999537
• MDR Text Key: 256215970
• Report Number: 2024168-2021-04970
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2021
• Device Catalogue Number: CDS0705-NTW
• Device Lot Number: 01021U138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER