MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Model Number 22437-19

Device Problems Premature Activation (1484); Material Split, Cut or Torn (4008)

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

Event Date 01/20/2021

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

It was reported that after cerebral angiography, the patient was found to have severe stenosis at the bifurcation of the left common carotid artery and internal carotid artery.An emboshield nav6 (5.0) embolic protection system (eps) was selected to be used; however, during prep, the delivery catheter was found to have a tear after the filter prematurely expanded.The filter was noted to be exposed from the delivery catheter.Another emboshield nav6 (5.0) was used successfully to complete the procedure.There was no patient involvement and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The torn dc pod was confirmed.The reported premature deployment was not tested.The dc pod was separated distal to the marker, and the separated portion remained inside the filtration element.The dc pod also had noted a split.The stretched coils and kink are likely due to case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the filter was pulled into the pod too quickly or with force causing the pod damage and when the delivery catheter was removed from the tray during preparation, the pod material tore and the filter deployed prematurely; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11322161
• MDR Text Key: 233113298
• Report Number: 2024168-2021-01143
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137747
• UDI-Public: 08717648137747
• Combination Product (y/n): N
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 22437-19
• Device Catalogue Number: 22437-19
• Device Lot Number: 0100562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1