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

Model Number 22438-19

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a mildly calcified and heavily tortuous left internal carotid artery.The emboshield nav6 filter was deployed, the lesion was dilated, then a 8-6x40mm acculink stent was successfully deployed without issue and it opened the lesion well.The patient then complained of anxiety and pain.Low flow was observed in the internal carotid and after removing the filter, the flow was restored.The filter was examined outside of the anatomy and a yellow fatty lipid was observed in the filter.Within 15 minutes, the patient had facial droop, right sided weakness, and confusion.Blood thinners were given to the patient.A stroke was diagnosed.The symptoms lasted longer than 24 hours.Per the physician, the emboshield nav6 filter and acculink stent are not at fault and had nothing to do with the symptoms.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of cerebrovascular accident, pain and weakness are listed in the emboshield nav6 instructions for use, as known possible adverse events that may be potentially associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported treatment with medications appears to be due to case circumstances.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: 10869179
• MDR Text Key: 217147189
• Report Number: 2024168-2020-09745
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8-6X40MM ACCULINK; 8-6X40MM ACCULINK
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 84 YR
• Patient Weight: 55