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 identified no similar complaints.The investigation determined that the reported difficulties and subsequent treatments were related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The nav6 referenced is filed under a separate mfr report number.
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It was reported that the procedure was to treat a lesion located in the left carotid artery that was calcified and tortuous.The emboshield was positioned and deployed distal to the lesion without any issues.The acculink stent was advanced to the lesion.The sheath was re-positioned but lost position, resulting in the stent deploying in an unintended location, possibly in the left common carotid.The stent delivery system was removed without issue.While pulling the emboshield filter toward the sheath, it became entangle with the implanted stent.Attempts were made to advance the retrieval catheter, but because the filter was entangled with the stent, it could not be collapsed into the retrieval catheter.The patient was taken to surgery for removal of the filter and stent.No additional treatment was provided, and the patient remains in good condition.No additional information was provided.
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