Catalog Number ERES30030X |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); Stenosis (2263)
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Event Date 06/19/2018 |
Event Type
malfunction
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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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Event Description
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During the procedure, an attempt was made to use one endeavor resolute drug eluting stent to treat a non-tortuous and severely calcified lesion located in the proximal circumflex artery, exhibiting 90% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent deformation occurred during positioning due to use of the device in difficult lesion morphology.It was informed that difficulty was experienced while advancing the stent and therefore it was pulled back.Stent deformation was seen when it was removed.Patient status post-procedure is alive with no injury.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device evaluation: a kink was evident on the hypotube 9.5cm distal to the strain relief.The stent had moved distally on the balloon and was not positioned on the balloon between the markerbands as per specifications.Deformation was evident to the distal stent wraps with struts bunched, raised and overlapping.Deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel due to the displacement of the stent over the distal tip.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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