28-may-2024 additional information: after additional correspondence with the local staff, it was clarified that the stent was released outside patient after device withdrawal by the physician.The physician further confirmed that he did not remember anything got stuck during the intervention.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.The affected device was returned with the stent being fully released stent and located on the proximal portion of the device shaft.However, the local staff later clarified that the device was manipulated after the reported event since the stent was released outside patient after device withdrawal.The outer shaft has been retracted by about 46 mm.The outer shaft is constricted, kinked and has buckled at several locations.Outside of the deformed zones, the shaft dimensions comply with the specification.The proximal stent stopper shows mild compression marks and the proximal end of inner shaft is compressed.The findings indicate that the stent was blocked and pulled against the proximal stent stopper when the outer shaft was retracted.The blockage of the stent was most likely related to uncommonly high friction between the stent and the retractable outer shaft.Moreover, the device tip shows severe indentations, indicating that the device may got stuck.However, after additional correspondence with the local staff this could not be confirmed.Review of the production documentation verified that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was identified.The final root cause for the complaint event could not be determined.
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