Medtronic received the following information obtained from the journal article entitled: ¿expanded petticoat technique to promote the reduction of contrasted false lumen volume in patients with chronic type b aortic dissection¿ arkadiusz kazimierczak, md, phd, pawel rynio, md, phd, tomasz jedrzejczak, md, phd, krzysztof mokrzycki, dm, phd, rabih samad, md, phd, miroslaw brykczynski, md, anita rybicka, phd, labib zair, md, phd, and piotr gut owski, md https://doi.Org/10.1016/j.Jvs.2019.01.073.If information is provided in the future, a supplemental report will be issued.
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Endurant stent graft systems were implanted in patients for the endovascular treatment of chronic type b dissections.The following adverse events were observed: acute renal failure, peripheral embolization, wound complications, interventional treatment.
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Additional information received; it was confirmed by the article author that no adverse event were noted as specifically related to any medtronic devices.It was confirmed that for the proximal thoracic device, a valiant freeflow stent graft device was used and a closed web tapered valiant stent graft was used medially with 5-10% oversizing in both areas.The endurant iliac extension used ranged from 16-20mm diameter and were 156mm in length.If information is provided in the future, a supplemental report will be issued.
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