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

Model Number CDS0701-NTW

Device Problems Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

The device was returned and investigated.Returned device analysis did not confirm the reported single gripper actuation issue.The discrepancy between what was reported (one gripper did not lower) and what was observed (no gripper actuation issue) is likely due to varying amounts of tension felt by the device during procedure versus the returned product analysis.The reported difficult or delayed positioning (leaflet grasping) could not be tested as it was related to patient/procedural conditions.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.The patient effect of tissue damage as listed in the mitraclip g4 system instructions for use (ifu) is a known possible complication associated with mitraclip procedures.Based on the information available, a cause for the reported single gripper actuation issue cannot be determined.It is likely that the small tissue caught on the gripper was restricting the gripper¿s actuation ability however this cannot be confirmed.The reported difficult or delayed positioning (leaflet grasping) was due to challenging anatomy (restricted posterior leaflet).The reported tissue damage was due to procedural conditions as it was noted that a small tissue was caught on the gripper during the procedure.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed for gripper actuation issues and tissue damage.It was reported that this was a mitraclip procedure, treating mitral regurgitation (mr) of grade 3-4.The clip delivery system (cds) was prepared for use and no issues were noted.The cds was advanced into the anatomy without difficulty.Grasp attempts were made; however, due to the restricted posterior leaflet, difficulty was noted.Additionally, it was noted that the anterior gripper would not drop.The clip was locked and unlocked, but the gripper did not lower.The device was removed and the procedure continued with use of a second cds.On the back table, the device was examined and it was noted that there was a small amount of tissue caught on the gripper.It was thought that the tissue was restricting the gripper.The tissue was removed and the gripper functioned appropriately.The physician was not concerned with the tissue damage, as the implanted clip was able to reduce the mr to grade 1.The procedure ended with the patient in stable condition.There was no clinically significant delay.No additional information was provided.

• 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: 11305586
• MDR Text Key: 231154730
• Report Number: 2024168-2021-01048
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00922U234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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 Outcome(s): Other