Catalog Number ERES27518X |
Device Problems
Difficult To Position (1467); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the distal tip of the device is damaged as the stylette could not be removed due to hardened blood/contrast.The stent was positioned on the balloon between the inner shaft markers as per specification requirement.The 11th distal stent segment was deformed with raised struts.(b)(4).
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Event Description
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It was reported that the physician was attempting to use an endeavor resolute rx drug eluting stent to treat a severely calcified and moderately tortuous lad lesion exhibiting 75% stenosis.The lesion had been pre-dilated.The device was removed from its packaging as per ifu and inspected with no issues noted.It was reported that resistance was encountered when advancing the device and it was reported that the stent deformed in-vivo during positioning.The device was replaced with another endeavor resolute to complete the procedure.The physician commented that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related.No patient injury reported.Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity).This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.
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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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