The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that the stent is severely deformed at its proximal end.Several stent struts are bent outwards.The stent has dislodged but it could be clarified that the stent was separated from its delivery system by the hospital staff after successful withdrawal of the instrument.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that all struts were initially crimped on the balloon.Review of the production 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, no manufacturing or material related root cause could be determined.
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