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Lot Number UNKNOWN |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4)-unique stent design with continuous cobalt wire can avoid protruding immediately after percutaneous coronary intervention compared to classical tubed stent https://doi.Org/10.1093/eurheartj/ehy566.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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The aim of this study was to evaluate the difference of the protrusion estimated by (b)(6) between r-zes and other kinds of tubed stents.Thirty lesions had r-zes and 106 lesions had classical tubed stents.There was no significant difference in the baseline characteristics including the frequency of acute coronary syndrome (acs) and the main plaque component estimated by oct.Maximum distance of irregular protruding was lower in r-zes compared to tubed stents.Other abnormal findings such as edge dissection, malapposition and under-expansion were similar between the two groups.The study concluded that r-zes with unique design with the continuous wire that is molded into a sinusoidal wave and wrapped in a helical pattern can avoid the intra-stent irregular protrusion, especially for acs lesions.
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Search Alerts/Recalls
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