Medtronic received the following information obtained from the journal article entitled; incidence and predictors of vascular complications in transaxillary tavi.Eurointervention (france), volume:15,issue:15, e1325-e1331 : feb 2020 doi: 10.4244/eij-d-19-00588 van der wulp, kees; thijs, ina; van wely, marleen; loverbos, anton; gehlmann, helmut; verkroost, michel; van garsse, leen; kievit, p eter; vart, priya; el messaoudi, saloua; bosboom, dennis; morshuis, wim; van royen, niels.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Sentrant sheaths were used as an accessory devices in transcatheter aortic valve implantation (tavi) procedures.The following serious injuries were observed: dissection, stenosis, perforation, surgical intervention, thrombosis.Death events were also reported however there is no causal link that sentrant sheath may have caused or contributed to the deaths.
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