The complaint stent was returned in its box and pouch.The stent is still mounted on the bib catheter.The stent and bib are bloody.The 14fr hemostasis valve tool is on the shaft of the catheter.The covering is completely detached.There are 4 glue spots on the covering.The stent is stuck to the balloon due to a coating of contrast.The od of the stent is 3.95mm (0.155").All covered cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering attachment strength.The sample from this lot of stents had a covering attachment strength of 2.13lbs, which is well above the minimum specification.The production traveler (device history record) was reviewed and no issues were found.All deices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.The root cause can not be positively determined, however, it is likely that the hemostasis valve tool was not inserted far enough to defeat the hemostasis valve.A covered cp stent mounted on a 14mm bib will pass through a 12fr introducer.If the 14fr hemostasis tool had defeated the valve, the bib-stent combination should have easily entered the sheath.The id of the 14fr hemostasis valve tool is 0.204".The od of the crimped stent is 0.155".The covering should not have caught on anything with 0.049" of extra space.
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