Combination product: yes.Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.It should be noted that, according to the physician, the orsiro us was properly deployed and the perforation was successfully sealed with the second orsiro.The stent information worksheet clearly states that there was no malfunction with the complaint device.It further should be noted that the ifu clearly states that pre-dilatation is mandatory.
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