Device Problems
Material Distortion (2977); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Date 01/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Event date: date article was accepted.Journal article: contribution of optical coherence tomography imaging in management of iatrogenic coronary dissection.N.Barber-chamoux et al./ cardiovascular revascularization medicine 17 (2016) 138¿142 cardiovascular revascularization medicine 17 (2016) 138¿142 http://dx.Doi.Org/10.1016/j.Carrev.2016.01.009 1553-8389/© 2016 elsevier inc.All rights reserved.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The physician decided to treat a cto lad artery with a resolute integrity drug eluting stent.One month later, during a myocardial tomoscintigraph prompted by the reoccurrance of angina, apical ischemia was shown.Angiograph showed a previously unnoticed dissection at the distal end of the previously implanted stent with a plaque rupture inducing stenosis.Under expansion of the stent due to fibrocalcific plaque.Angioplasty was carried out with 2 stents implanted with post dilatation of the proximal stent.Final acquisitions show a good result of stent apposition with a non-compressive distal edge dissection for a diameter less than 2 mm.The one-year follow-up does not show any angina recurrence.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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