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

Model Number CDS0701-XTW

Device Problems Retraction Problem (1536); Material Separation (1562); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Noise, Audible (3273)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed for cap detachment.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.The clip delivery system (cds) packaging was opened.It was noted that the red cap was loose in the box and fell out when the box was opened.The decision was made to continue use with this cds.The cds was advanced into the anatomy and no issues were noted.The delivery catheter (dc) fastener was loosened and the sleeve was pulled back.Per physician comment, it felt "funny", and did not pull back as normal.A noise was heard, but the decision was made to continue use.The physician was able to grasp both leaflets and the clip was deployed without issue.The functional mitral regurgitation was reduced from grade 4 to grade 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.The device was used after damage was noted.It should be noted that the mitraclip g4 system instructions for use (ifu), warns the user to not use the device if damage is detected.This deviation from the ifu did not result in the reported event or any other issues.All information was investigated, and a cause for the reported retraction problem resulting in noise cannot be determined.Additionally, the investigation determined that the reported unstable/loose red luer cap appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.H6 medical device problem codes 1562 and 2906 were 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: 11227846
• MDR Text Key: 230023727
• Report Number: 2024168-2021-00603
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 01027U326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 78