(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed on the returned device.The deployment issue, inaccurate delivery and resistance were not able to be confirmed as the stent was not returned.It is likely that the distal sheath was entrapped or bent within the tortuous anatomy causing the noted resistance with the slider and preventing the sheath from retracting to deploy the stent.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 of the reported lot revealed no other similar incidents.The investigation determined that the reported difficulty was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
It was reported that the procedure was to treat a lesion located in the right internal carotid artery.After predilatation, the rx.014 acculink ii 7-10/40 was advanced with anatomical resistance through the moderately calcified, heavily tortuous groin and aorta prior to successfully crossing the target lesion.During deployment of the acculink stent, it was reported that the handle slider was difficult to pull back for approximately 3/4 of the way and the tactile feel was "spongy".As a result, the deployment was aborted.When the device was removed from the anatomy, it was observed that the stent was fully deployed but only covering 2/3 of the target lesion.A non-abbott device was used to fully cover the target lesion without issue.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
|