The device was not returned for analysis.It is likely that the distal sheath was entrapped or bent within the heavily calcified and heavily tortuous anatomy such that further deployment was restricted.Additionally, removing the delivery system with the stent partially apposed to the vessel wall caused the difficulty removing and stent separation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported difficulties are due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a lesion located in the heavily calcified, heavily tortuous, right external iliac with a absolute pro vascular stent.Access was through the left common femoral artery using an up and over technique.Pre-dilatation with the balloon did not fully expand the heavily calcified lesion and there was a steep carina due to tortuosity.During stent deployment, approximately 1/3 of the stent deployed easily, but then the system locked up and the stent could not be deployed any further.The decision was made to remove the delivery system; however, in the process of removal, due to resistance felt, the stent implant fractured leaving part in the right iliac and part in the left iliac artery.Two stents were deployed over each segment of the fractured stent pinning the fracture stent pieces to the vessel wall.The stents also served to cover the intended lesion treating the lesion.The patient is reported to be stable.No additional information was provided.
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