Medtronic received the following information from the journal article entitled; balloon protection of the left subclavian artery in debranching thoracic endovascular aortic repair yoshimasa seike, hitoshi matsuda, yosuke inoue, atsushi omura, kyokun uehara, tetsuya fukuda, and junjiro kobayashi j thorac cardiovasc surg 2019 volume 157 (4) https://doi.Org/10.1016/j.Jtcvs.2018.10.061.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Valiant and talent stent grafts, and non-medtronic stent grafts, were implanted in patients for debranching thoracic endovascular repair.The following events were reported: serious injury: cva pneumonia embolism paresis paraplegia type a aortic dissection aortic aneurysm rupture haemorrhagic cva chronic kidney disease chronic heart failure stent-graft infection patient deaths were also reported.There was no information to suggest any device failure caused or contributed to a death.The cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable as mdr or vigilance unless clearly stated as being associated with medtronic product.
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