It was reported that the procedure was to treat a heavily calcified, heavily tortuous, 95% stenosed, de novo internal carotid artery (ica).The 0.14 acculink carotid stent delivery system (sds) was slowly advanced to the lesion with resistance met due to the difficult anatomy.Once the sds reached the lesion, several attempts were made to release the stent, but it failed to deploy.The device was removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.Another unspecified device was used to successfully complete the procedure.No additional information was provided.
|
Visual analysis was performed on the returned device.The reported separation and damage to the shaft was confirmed.The advancement difficulty 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 other complaints.The investigation determined that the reported difficulties were related to case circumstances.It is likely that anatomical conditions contributed to the reported difficulties.It is likely that during the attempt to advance against resistance as the device was advanced through the heavily calcified, heavily tortuous anatomy, the hypotube kinked preventing deployment and during removal, the kinked hypotube separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|