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

Model Number CDS0601-NTR

Device Problems Break (1069); Positioning Failure (1158); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

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.(b)(4).

Event Description

This is filed to report the gripper actuation issue and suspected griper line break.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.The first clip was successfully deployed.A second clip delivery system (cds) was advanced to the mitral valve; however, it was observed that the posterior gripper would not come up.The physician decided to cycle the grippers, but the gripper would still not come up.Then the clip was re-locked, and the gripper was able to go up.The procedure continued and the clip grasped the leaflets.The physician was not satisfied with the leaflet insertion; and therefore, the clip was inverted and pulled into the left atrium to re-align the clip when it was observed that the anterior gripper was down when it should have been up.It was noted due to the physician not feeling any tension when moving the gripper lever, that it was suspected that there was a gripper line break.Therefore, the cds was removed with the clip attached and a new cds was used to complete the procedure.Two clips were implanted, reducing mr to 2.There were no adverse patient effects and no reported 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 and unstable were confirmed via returned device analysis.The reported positioning failure and improper or incorrect procedure method could not be replicated under testing environment as it was related to procedural circumstances.Per the intended use section of the mitraclip system instructions for use (ifu), grasping the leaflets and verifying the grasp the user is expected to lock the clip if grippers are not confirmed to be lowered.The reported improper or incorrect procedure or method appears to be due to use error which likely influenced the reported gripper actuation issue.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 did not identify any other similar incidents reported from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

All available information was investigated, and the reported gripper line break, gripper actuation and unstable were confirmed via returned device analysis.The reported positioning failure and improper or incorrect procedure method could not be replicated under testing environment as it was related to procedural circumstances.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 did not identify any other similar incidents reported from this lot.Per the intended use section of the mitraclip system instructions for use (ifu), grasping the leaflets and verifying the grasp the user is expected to lock the clip if grippers are not confirmed to be lowered.The reported improper or incorrect procedure or method appears to be due to use error which likely influenced the reported gripper actuation issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9632336
• MDR Text Key: 177390666
• Report Number: 2024168-2020-00900
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90905U184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Age: 80 YR