Combination product: yes according to the case description the patient underwent successfully a percutaneous coronary intervention with 3 orsiro drug-eluting stents to the rca and om.The day after the patient went into vasovagal attack with bradycardia and hypotension, the coronary angiography revealed a thrombotic occlusion of the vessel segments treated the day before.The device itself was not returned to biotronik and could therefore not be subjected to a technical investigation.However, the provided operative report and the angiographic material were reviewed to identify a potential technical complication or device malfunction.Further the production documentation of both products was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Review of the production documentation for the product detailed above confirmed that both devices were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation and the conducted investigation no device deficiency or manufacturing related root cause could be identified.
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