The complaint stent was not returned so the root cause of the complaint cannot be positively determined, however, there are a few factors that could have contributed to the detachment.The stent was crimped down on an 18mm bib, which is well below the recommended 26mm minimum.Crimping a 10 zig stent on a smaller bib would cause the zigs at the end of the stent to overlap.This would increase the probability of a detachment by adding stress to the covering's adhesive spots.The ring mandril was not used during the crimping process.The mandril reduces the risk of bending the stent, which can also stress the covering's adhesive spots.The stent had been soaking in ns with heparin solution 15 minutes prior to crimping.The ifu and stent mounting procedure recommend crimping dry stents.All covered and mounted cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering strength.The sample from this lot failed at 3.49lbs, well above the 1.5lb minimum.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.
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