Combination product: yes.The complaint instruments were not returned 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.In addition, the provided angiographic material was reviewed.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.During lot release inspection in the compliance test, the expanded stent outer diameter is tested for a defined amount of samples from every lot.The provided angiographic material was reviewed.The implantation of all five stents in the different target lesions in the lca is shown, partly followed by post-dilatations as not all of them are recorded.The complaint events of the difficulties in crossing the complaint stents with the balloons for post-dilatation are not visible in the angiographic material.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.
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