It is reported that a endeavor resolute drug eluting stent was intended to treat a severely calcified lesion in the lad.The lesion had 85% stenosis and minor tortuosity.The patient also had a totally occluded rca.No issues were noted with the device packaging.The device was inspected prior to use with no issues noted.The lesion was pre-dilated twice for 5 seconds, at 8 atm.20% stenosis remained after pre-dilation.The device was successfully implanted at the target lesion, but it is reported that the "stent was shortening from the left coronary into lad , and could not cover the lesion." no stent deformation or migration was noted.The device remains in the patient.The physician deployed another endeavor resolute rx of same size to complete the surgery.A non-medtronic device was used to treat the cto in the rca.The physician believes the cause of the event may be due to a product defect.No patient complications are reported.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).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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