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 device revealed that the balloon has been inflated.Microscopic analysis of the balloon surface revealed clear visible stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent is severely deformed over its entire length.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.The device in question was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause is most likely related to external factors during the procedure.The presence of two guidewires, a trapliner and the complaint instrument inside the guiding catheter may have been a contributing factor to the complaint event.
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