Visual and functional inspections were performed on the returned device.The reported premature deployment was confirmed as the stent was exposed and over the tip for a length of 5mm.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 identified no other similar complaints reported from this lot.The investigation determined that the reported premature deployment was likely due to inadvertent mishandling.It is likely that during removal of the stylet, the tip was inadvertently pulled such that the stent slightly pulled out.It may also be likely that the stylet was not removed per the instructions for use.The delivery system preparation section instructs to gently twist and pull to remove the tip mandrel.If the tip mandrel is not easily removed, do not use the device.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 during device preparation and before use, when the absolute pro was removed from the box, some struts of the stent were flared, rendering the device unusable.The device was discarded and another absolute pro 8mm x 60mm and was used to complete.No additional information was provided.Device analysis on 8/31/2021 revealed the stent was returned exposed and not flowered.
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