The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the sds failed to cross the heavily calcified anatomy which caused the reported failure to advance, difficulty to remove and ultimately the stent dislodgement.There is no indication of a product quality issue with respect to the design, manufacture.
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