The returned instrument was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the balloon is well folded and shows no signs of inflation, but the proximal balloon shoulder is slightly compressed.The stent is slightly deformed at its distal end, i.E.One strut is bent outwards.Microscopic inspection revealed stent imprints on the exposed balloon surface, indicating that the bent strut was initially crimped on the balloon.Outside of the deformed zone the crimped diameter of the stent complies with the specification.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent.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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