It was reported that the procedure was to treat a heavily tortuous left common carotid artery.The patient presented with an aneurysm.The physician accessed the right groin with a 6 x 9 non-abbott sheath.A 6-8/30 acculink stent device was advanced and the shaft made a 90 degree turn (large bend) at the aneurysm.A bend at the shaft was noticed.There was a bit of a resistance due to the anatomy, but the device was able to cross the target lesion.Initially, the physician could not get the stent to deploy.But then the stent ultimately did deploy.However, during removal, the device became separated at the shaft.Although a separation occurred, the separated portion remained on the micro wire and everything was simply pulled out.Nothing remained in the patient.The patient is stable.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Visual analysis was performed on the returned device.The reported separation and damage to the shaft were confirmed.The failure to advance and deployment issue were not able to be confirmed due to the condition of the returned device.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 identified no complaints.The investigation determined that the reported difficulties were related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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