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

Model Number CDS0701-NTW

Device Problems Unstable (1667); Component Missing (2306)

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

Event Date 05/12/2021

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.Na.

Event Description

This is filed to report the unstable flush port cap.It was reported the mitraclip procedure was performed to treat functional mitral regurgitation (mr).During the initial inspection it was noted that the neck that extends beyond the threads of the flush port on the delivery catheter (dc) handle was missing.Therefore, the red cap would not thread properly.The mitraclip delivery system (cds) was not used in the patient.The product was removed from the prep table and was replaced with a new cds.There was no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The returned device analysis did not confirm the reported missing component; however, the reported unstable red cap could not be tested as the delivery catheter (dc) handle top flush port was observed to be detached/broken and was returned in the packaging tray.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 reported from this lot.Based on the overall information, the reported material separation and unstable cap appears to be due to the observed detached/broken dc handle flush port.The observed detached/broken delivery catheter handle flush port appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 11936019
• MDR Text Key: 254524550
• Report Number: 2024168-2021-04656
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 10120U123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1