Low-frequency avoidable errors during transcarotid artery revascularization

ObjectiveTranscarotid artery revascularization (TCAR) seems to be a safe and effective alternative carotid endarterectomy (CEA) transfemoral stenting (TF-CAS). The TCAR system represents paradigm shift in the management of stenosis with potential for significant decrease periprocedural morbidity. However, as CEA or TF-CAS, is associated infrequent complications related user technical error, most which are preventable. Our goal describe these low-frequency events, provide guidelines avoiding them.MethodsThe U.S. Food Drug Administration (FDA) requires that all medical device manufacturers create receiving, reviewing, evaluating complaints (Code 21 Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established process by feedback, including may not meet FDA criteria, captured stored database detailed analysis. More than 13,300 cases have been performed; submitted were reviewed incidents serious injury complications, above beyond device-related events must reported FDA.ResultsA total 13,334 patients undergone worldwide between early 2011 December 2019 using SilkRoad device. Reported included 173 dissections (1.4% overall rate) common at access point, 22.5% managed without intervention therapy alone 24.3% converted (considered failing safely). Errors location stent deployment occurred 16 (0.13%), site being external (75%). One wrong side was placed patient high midline pattern bovine arch. Cranial nerve 11 (0.08%), only one persisted 3 months. There three pneumothoraces chylothorax. Many errors can recognized prevented careful attention detail.ConclusionsIn high-risk requiring treatment stenosis, proven an TF-CAS excellent safety profile. As this procedure often result error. Although significant, avoided through review collective experience date recognition pitfalls, we described.