Medtronic PLC, a maker of various medical devices, issued a voluntary recall on Wednesday, Feb. 17, of its Valiant Navion thoracic stent graft system the Financial Post reported.
The product was being used in a global trial of 87 patients when three stent fractures and one patient death were reported. Medtronic confirmed that stent fractures caused tears in the fabric tube, causing blood to leak from the implant’s channel. Upon a further examination, the company also observed seven patients who had a stent ring enlargement beyond the device’s design specifications.
Physicians worldwide are now being advised by the company to cease using the device until further notice. In a statement, the company said it is “currently conducting a comprehensive technical root cause investigation, including further review of follow-up clinical trial imaging and commercial complaints and imaging.”
The intended purpose of Medtronic’s Valiant Navion thoracic stent graft system is to reinforce large blood vessels that are at risk of rupturing as a result of an aneurysm or another such injury.
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Although the scope of patients affected by Medtronic’s new stent graft system is narrow, you or a loved one may have experienced an injury as a result of a similar medical device from a different manufacturer. If you believe you may have been affected by a defective medical device, you can seek fair and just compensation by pursuing legal action.
At Bertram & Graf, L.L.C., we offer a free initial consultation to help potential clients assess their legal needs. To schedule yours, get in touch with us online or by calling (888) 398-2277.