Catalog Number RONYX25022X |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis : there were numerous kinks on the distal shaft extending approx.3cm proximally from the proximal balloon bond.The distal shaft was kinked 11 and 11.6cm distal to the guidewire entry port.The stent was positioned on the balloon between the marker bands as per specifications.There was deformation to the 7th distal stent wrap with struts raised.A number of the stent wraps had stent struts misaligned.There was no deformation to the distal tip.Image review: the images confirm the lesion morphology of the obtuse marginal as reported by the account.The images capture two attempts to deliver unidentified balloons to the lesion site.The images do not capture the attempted delivery of the resolute onyx stent, or the subsequent deformation and withdrawal.An unidentified balloon is inflated to treat the lesion site.(b)(4).
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Event Description
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It was reported that the physician was attempting to use a resolute onyx rx drug eluting stent to treat a severely calcified and severely tortuous mid om lesion exhibiting 95% stenosis.No issues noticed when removing the device from its packaging and no damage noted to device packaging.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.During the procedure, the device passed through a previously deployed stent.Resistance was encountered and excessive force was used.It was reported that stent deformation occurred in vivo during positioning.The physician completed the procedure using poba.No patient injury reported for this event please note that this device resolute onyx is not marketed in the united states; however, it is similar to the united states marketed device 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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