it's a wire, they can go back to previous wire. Not huge news.
From Maude:
2135147-2012-00200: "An 8f amplatzer torqvue fx (tvfx) was used to deliver a 14mm amplatzer septal occluder (aso), however, the tvfx core wire fractured during device deployment. Less than 10mm of broken wire was attached to the aso's right atrial disc which remains in the patient. The tvfx was removed and the aso remains implanted."
2135147-2013-00003: "As the aso was being detached from the core wire, the tvfx's end screw broke leaving a 3mm piece in the aso pin which remains in the patient; he felt it would be too risky to remove the aso with the fractured end screw because of the risk of embolization."
2135147-2012-00201: "...the tvfx's core wire end screw broke during recapture causing the aso to embolize into the left atrium."
2135147-2013-00001: "The delivery sheath was positioned closer to the device and the vise was turned counterclockwise. The inner core wire released the aso but upon retracting it into the sheath, the end screw became detached and travelled to the right ventricle. The material was left in the ventricle and the patient is being closely monitored."
To which SJM replied: "...the failure was deemed to be not related to manufacturing."
Shitty delivery system impacting patients; seems like a big deal to me.
