The covered cp stent was returned in a biohazard bag.There is contrast on the stent, so the device was taken out of the packaging and handled in some manner.There is a 1.5cm tear at one end of the stent.All four glue spots are still attached.The stent was found to be out of round from the handling.The zigs at the end of the stent where the tear occurred are overlapped (refer to pictures).The id of the stent when it returned was 0.116".The id of the stent when shipped is 0.141".The complaint is confirmed.It appears that the covering got caught between the overlapped zigs and it likely tore when an attempt was made to remove the covering from between the overlapped zigs.One covered stent is tested from every lot for covering strength.The covering strength from this lot was 2.13393 lbf, which was above the specification required for release of the lot.In the instructions for use for the covered cp stent, it tells the user when prepping the stent to "avoid unwrapping the folds in the covering.This could cause it to catch and tear off of the stent." there is also a warning that states "excessive handling and manipulation of the covering while crimping the stent may cause the covering to tear off of the stent.".
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