As reported to numed on a report from the distributor: "inadequate cover fixation to stent.The cp stent cover got stuck in a cook checkflo 18fr introducer sheath while advancing the stent through the sheath.The physician saw the stent via fluoroscopy and felt resistance.They retracted back through the hemostasis valve and the cover came out separately from the stent.Umbilical tape was used to try to re-crimp the stent, however it did not work.The stent was advanced uncovered into the valve successfully.The indication the physician was using the product for: rvot and transcatheter valve implant.Crimping was involved only after the cover came off of the stent after initial advancement into introducer.The ring mandril was not used during the crimping process.The stent did not slip.Neither saline nor contrast media was used during prep.The inner balloon was inflated before the outer balloon.An inflation device with pressure gauge was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient condition post procedure was good, the case was successful"."it is unclear if the hemostasis tools were used".
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