A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.The device was not returned for evaluation and there were no angiographic imaging made available.The anatomical conditions were reported as challenging due to the tight bifurcation angle encountered but the iliacs were not reported as tortuous.It was stated that the bifurcation hub did not reach the proximal pin luer while attempting the deployment and that no section of the stent was unsheathed.The bonds were reported as being intact.The resistance experienced during the attempted deployment would suggest that there was a significant deployment force required to initiate the deployment of the stent possibly due to the anatomical condition of the vessels.Challenging anatomical conditions like the tight bifurcation angle reported can create increased friction between the device components of the delivery system and also between the delivery system and the introducer sheath.The ifu states the following "warning: if unexpected resistance is felt at the start of the deployment, do not force the movement of the bifurcation luer; instead, carefully withdraw the sds without deploying the stent." the significant deployment force experienced is a possible result of the challenging anatomical conditions encountered.The complaint was categorised as "unable to deploy".The exact root cause could not be established.
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