Catalog Number ERES27512X |
Device Problems
Use of Device Problem (1670); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Please note that this device (endeavor resolute rx) is not marketed in the united states; however, it is similar to the united states marketed device (resolute integrity rx).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 attempted to be used to treat a moderately tortuous, mildly calcified lesion in the distal lad, exhibiting 85% stenosis.There was no damage noted to the device packaging.There were no issues removing the device from the hoop.The device was inspected with no issues.The lesion was pre-dilated.It is reported that the stent failed to cross and it is indicated that the stent became damaged.The stent was also used past its expiry date.The stent was not implanted.The procedure was completed using another endeavor resolute device.No patient injury is reported.
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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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