Neither the complaint instrument nor the angiographic material was available 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 confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.However, it was reported that the heparin was not properly inserted into the vessel and the physician stated that the thrombosis is not related to the complaint stent but to the improper heparin insertion.
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