VALIANT NAVION THORACIC STENT GRAFT SYSTEM (2021-02-17)

Starting date:

February 17, 2021

Posting date:

March 11, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75095

Last updated:
2021-03-11

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  Reason
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  Affected products

Affected Products 

VALIANT NAVION THORACIC STENT GRAFT SYSTEM

Reason

The recall is being initiated in response to information identified in the Valiant Evo Global Clinical program, which studied the performance of the Valiant Navion Thoracic Stent Graft System.       

A total of 100 subjects were enrolled in the Valiant Evo Global Clinical Program. The information received indicated that there were three (3) subjects with stent fractures of which two (2) have confirmed type IIIb endoleaks, and seven (7) core lab analysis findings showing stent ring enlargement.

Medtronic has been informed of two (2) patients in the Valiant Evo Global Clinical Program who were observed to have stent fractures and type IIIb endoleaks upon review of the two- and three-year follow-up CT images. The first patient event was reported on 21-December-2020 and the second patient event was reported on 27-January-2021. The first patient died following reintervention, and the death was adjudicated by the trial's clinical events committee as aneurysm-related. Type IIIb endoleaks, if untreated, can potentially lead to aneurysm rupture.

Physicians should immediately cease use of the Valiant Navion Thoracic Stent Graft System and return any unused product to Medtronic.

Medtronic is currently conducting a comprehensive technical root cause investigation, including full review of follow-up clinical trial imaging, as well as commercial complaint and imaging data analysis.

This notification contains a description of the information known to date and patient management recommendations.

Affected products