Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, five photographs and a video taken from the angiogram were reviewed.The technical investigation confirmed that the stent has dislodged from the balloon.The balloon is well folded and shows no signs of inflation.Stent imprints were observed on the exposed balloon surface, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was implanted and thus not returned for analysis.The photographs show the occluded target lesion prior to, during and after its treatment.The affected device is shown during positioning but the actual complaint event is not visible.The video provided shows the dislodged stent in the distal om.The photographs and the video do not contain further relevant information regarding the root cause of the complaint.Review of the production documentation confirmed that the device was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent retention force of a defined amount of samples is tested by means of manufacturing process output monitoring.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.
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