The following article was reviewed: 'outcomes of endovascular and contemporary open surgical repairs of popliteal artery aneurysm'; ying huang, m.D., phd; peter gloviczki, m.D.; gustavo s.Oderich, m.D.; audra a.Duncan, m.D.; manju kalra, mbbs; mark fleming, m.D.; william s.Harmsen, ms; and thomas c.Bower, m.D.; division of vascular and endovascular surgery and department of health science research, mayo clinic; copyright 2014 by the society for vascular surgery; http://dx.Doi.Org/10.1016/j.Jvs.2014.03.257; presented at the thirty-seventh annual meeting of the midwestern vascular surgical society, chicago, ill, september 6-8, 2013.The purpose of this study was to compare outcomes after endovascular repair and contemporary open repair of popliteal artery aneurysms.Clinical data of popliteal artery aneurysm patients treated between 2005 and 2012 was reviewed.The gore® viabahn® endoprosthesis was the device used for endovascular repair.The article reported on page 634 reintervention occurred in one patient as a result of device infolding.
|
Corrected data: h6 - conclusions code 1.Additional manufacturer narrative: no actual event date was provided.Therefore, date of event is an estimate based on publication date of the article.Review of the manufacturing records could not be completed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no further investigation is possible.All information has been placed on file for use in tracking and trending.
|