Add info: the stent was deployed with no difficulty.Force was not required to remove the delivery system.It was reported that after post-dilatation, the stent fractured.It was reported that the stent did not deform, but a breakage occurred.There was no difficulty noted during the removal of the guidewire.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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