(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified anatomy resulting in the reported failure to cross and stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that the procedure was to treat a stenosed, non-tortuous and heavily calcified lesion in the distal right coronary artery.A 2.25x12mm xience alpine stent delivery system (sds) failed to cross the lesion due to the heavy calcification.A 2.50x08mm xience alpine (sds) was then advanced in an attempt to cross the lesion; however, the stent dislodged before reaching the lesion site due to the heavy calcification.A 2.50x08mm xience alpine stent was deployed over the dislodged stent crushing it against the vessel wall.The procedure was successfully completed with a 2.75x12 and 3.0x15 xience alpine stents.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
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