The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the lot number was not reported and the product was not returned for analysis.It is possible that the stent was not fully apposed to the vessel wall resulting in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility recoil cannot be determined.The treatment appears to be related to the operational context of the procedure as an unspecified stent was implanted inside the original stent and post-dilatation was performed again, resolving the issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
|