The detached covering has been confirmed.The covering is undamaged and four glue spots are visible on the covering.The od of the stent is 0.167".The stents have an od of 0.181 when shipped from numed.It appears the covering became detached when the physician attempted to remove it from the sheath to re-crimp the stent.A special tool needs to be used to insert the stent through the hemostasis valve, so that the cover will not catch.When pulling back through the hemostasis valve, the covering will catch and detach from the stent.The od of the stent was 0.167" which is very close to the od of the stent when shipped from numed.It is likely that the stent shifted because it was not fully crimped on the balloon.This indirectly led to the covering issue since it had to be removed back through the hemostasis valve in order to re-crimp the stent on the balloon.The instructions for use states that the stent should be crimped until no movement is felt on the catheter.It also states to place a small amount of undiluted contrast to coat the stent and improve adherence to the balloon.Numed is unable to confirm whether or not this was followed.The distributor has stated that no other information is available.
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