MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP XTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number CDS0602-XTR

Device Problems Break (1069); Unstable (1667); Difficult to Open or Close (2921)

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

Event Date 05/06/2021

Event Type  malfunction  

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.

Event Description

This is being filed to report gripper actuation issue.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade 3-4.The clip delivery system (cds) was advanced to the mitral valve and grasping was performed.However, the first grasp did not show a desired mr reduction; therefore, the leaflets were grasped more lateral of the mitral valve.When the grippers were lowered it was noted that there was no action and in echocardiography it showed the grippers could not be raised.An attempt was made to lower and raise the grippers but there was no movement and the gripper lever could be moved too easily.It was then noted that gripper line was broken.Therefore, the cds was removed and replaced with a new cds.One clip was implanted, reducing mr to 1-2.The leaflets did not show any injuries caused by the damaged cds.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported gripper line break, gripper actuation issue and unstable gripper lever were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot-specific product issue.Based on the information reviewed, while the gripper actuation issue and the unstable gripper lever (gripper able to retract without resistance) were due to the gripper line break, however, a cause for the gripper line break could not be determined.There is no indication of a product issue with respect to design, manufacture, or labeling of the device.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11894006
• MDR Text Key: 252942678
• Report Number: 2024168-2021-04452
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 01211U116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Age: 79 YR