The device was returned for analysis.The reported activation failure including expansion failures was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was able to be confirmed.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 incidents from this lot.The reported patient effect of hypotension is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.Reportedly, it was noted the thumbslide was not slid all the way back.It should be noted that the supera peripheral stent system instructions for use states: following confirmed implantation of the supera stent, retract the thumbslide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the thumbslide was not slid all the way back, thus during withdrawal the nose cone interacted with the deployed stent resulting in the reported activation/deployment failure and ultimately resulting in the reported/noted material separations (tip, inner member).The reported/noted difficulties possibly resulted in the reported hypotension however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure as a femostop was used to apply pressure to the access site as during removal of the supera it created a lager hole.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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