Catalog Number RSINT35030X |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: the device returned with sheath and stylette attached.The stent was positioned on the balloon between the marker bands as per speci fications.Deformation was evident to the 29th and 30th stent wraps with struts raised.No deformation was evident to the distal tip.The guidewire lumen patency was verified with a 0.015 inch mandrel.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 resolute integrity drug eluting stent to treat a severely calcified lesion located in the distal 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 used during delivery.It was reported that the stent failed to cross the lesion due to use of the device in difficult lesion morphology.Patient status post-procedure is alive with no injury.Analysis of the returned device showed that the stent was deformed.
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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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Search Alerts/Recalls
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