(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance the device and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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 failure to advance, difficulty removing the device, and stent dislodgement to be related to interactions with the patient heavy tortuosity and heavy calcified anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported the procedure was to treat a lesion with heavy tortuosity and heavy calcification in the circumflex (cx) coronary artery.Pre-dilatation was performed and the 3.5 x 12 mm xience alpine was advanced, but could not cross the lesion due to the anatomy.During withdrawal, the xience alpine stent dislodged in the left main artery due to the resistance with the anatomy.A balloon catheter was used to compress the dislodged stent against the vessel (healthy tissue) in the left main artery.The patient was in stable condition, but referred for surgery due to the heavily calcified vessel and nothing was able to cross the lesion.No additional information was provided.
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