Catalog Number RSINT35022UX |
Device Problems
Fracture (1260); Material Distortion (2977)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 06/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the physician was attempting to use an resolute integrity rx drug eluting stent to treat a severely calcified and tortuous proximal cx lesion with 90% stenosis.No damage was noted to the device packaging and no issues noted removing the device from the hoop/tray.The device was inspected with no issues noted.During the procedure it was reported that the device did not pass through a previously deployed stent.Resistance was encountered during delivery but no excessive force was used.It was reported that the device was placed and deployed successfully.The balloon of the device successfully deflated post stent deployment.No difficulty experienced when removing the guidewire.Balloon or delivery system did not snag on the deployed stent.It was reported that following the procedure, the patent returned with symptoms.An angiogram was performed and a focal lesion in the previously deployed stent was noted.The physician believes that the stent was fractured.The stent was then ballooned and a diencephalic stent was placed.
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Manufacturer Narrative
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Image review: the images capture the deployed stent prior to delivery and inflation of the balloon devices.The stent does appear to have conformed to the shape of the lesion.The stent appears to be intact with no fracture/break visible.A number of balloon inflations are performed and another stent is deployed on the proximal side.A good faith effort will be made to obtain the applicable information relevant to the report.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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