It was reported that the stent became stuck on the wire.A 7x150x130 innova stent was selected for use.The stent was deployed, however, the inner lumen of the innova became stuck on the non-bsc guidewire.The device was attempted to be removed from the guidewire but it was unsuccessful.The physician then forcefully broke apart the innova delivery system and was able to remove the entire system in pieces, and the guidewire was removed as well.A new guidewire was inserted and the procedure was completed by ballooning the innova.There were no patient complications reported.
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It was reported that the stent became stuck on the wire.A 7x150x130 innova stent was selected for use.The stent was deployed, however, the inner lumen of the innova became stuck on the non-bsc guidewire.The device was attempted to be removed from the guidewire but it was unsuccessful.The physician then forcefully broke apart the innova delivery system and was able to remove the entire system in pieces, and the guidewire was removed as well.A new guidewire was inserted and the procedure was completed by ballooning the innova.There were no patient complications reported.Device evaluated by mfr: the outer sheath was kinked at the nosecone.The mid shaft showed a kink located at 9.5cm from the proximal side of the marker band.The proximal inner shaft was separated from the device and was returned.The inner liner was separated from the device and not returned.The tip is part of the inner liner portion that was detached, so the tip was detached from the device and not returned.The stent was not returned.The handle was separated to inspect for further damage, and no other damage was noticed.The guidewire sticking issue may have been caused by the device being kinked at the nosecone during the procedure or an adverse event during the procedure.The separations were caused by possible intoducer sheath interference when the procedure was completed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
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