Catalog Number ERES35015X |
Device Problems
Break (1069); Fracture (1260); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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An endeavor resolute drug eluting stent was intended to be used during a procedure.The lesion was located in the distal rca, and exhibited 85% stenosis.The lesion was pre-dilated.It was reported that the guidewire passed through the lesion, then when pre-expansion was performed and during stent implantation, it was found that the stent was broken and did not pass the lesion.No patient injury was reported.
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Manufacturer Narrative
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Stent struts were broken, not deformed.No other type of damage was noted.Patient is fine.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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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