Combination product: yes.The complaint instrument was not returned for analysis.Therefore, no technical investigation on the subject could be performed.Only two fragments of the guiding extension catheter which was used in the intervention were returned for technical investigation.All fragments were inspected, and it could be verified that the dislodged stent, its fragments or parts of the delivery system was not found inside of the fragments.Review of the production documentation verified that the instruments were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.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, the stent retention force and the tensile strength of the delivery system of a defined amount of samples is tested from every lot.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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