The device was returned for evaluation.The covering is completely in tact with no issues.All four glue spots are attached and there was nothing wrong with it.The distal end of the stent had one zig that was bent out (see attached pictures - 835 complaint stent and 835 complaint stent2).Numed pulled a comparative stent to try and similate the bend in the zig like the complaint stent.When sliding the stent on a balloon catheter, when the balloon did not have a vacuum on it, the stent caught on the balloon during the advancement and ended up with similar damage to one of the zigs (see attached pictures - 835 comparative1 and 835 comparative2).Numed fully inspects all zigs on each stent before it is placed in a bottle for packaging.The bent zig had to had occurred at the user facility.Similar damage was observed while forcing a stent over a balloon that had not been properly prepped, making improper handling the most likely cause of the complaint.(b)(4).
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