UNIQUE DEVICE IDENTIFIER (UDI#): IN THE ABSENCE OF A REPORTED PART NUMBER, THE UDI CANNOT BE CALCULATED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR INCIDENT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. THE REPORTED PATIENT EFFECTS OF CEREBROVASCULAR ACCIDENT, HYPOTENSION AND PAIN ARE LISTED IN THE EMBOSHIELD NAV6 INSTRUCTION FOR USE (IFU), AS KNOWN POSSIBLE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT WAS DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE TWO ADDITIONAL EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CAROTID ARTERY. AN UNSPECIFIED STENT WAS DEPLOYED IN THE CAROTID ARTERY SIX MONTHS AGO AND THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2020 WITH IN-STENT STENOSIS THOUGHT TO BE THROMBOSIS. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED AND THE FILTER WAS DEPLOYED; HOWEVER, IT WAS REALIZED THAT A 300CENTIMETER (CM) GUIDE WIRE WAS NEEDED IN ORDER TO USE THE PROPOSED SUCTION CATHETER. THE FILTER WAS REMOVED WITHOUT ISSUES. A 300CM GUIDE WIRE WAS ADVANCED AND A SECOND NAV6 FILTER WAS ADVANCED; HOWEVER, THE GUIDE WIRE WAS PULLED IN ACCIDENT AND THE FILTER MOVED FROM ITS DESIRED LOCATION. THE FILTER WAS REMOVED WITHOUT ISSUES. THE SAME THING HAPPENED WITH A THIRD NAV6 FILTER AND IT WAS REMOVED WITHOUT ISSUES. A FOURTH NAV6 FILTER WAS ADVANCED AND THE GUIDE WIRE WAS LOCKED IN PLACE TO THE SHEATH; HOWEVER, THE PATIENT EXPERIENCED GROIN PAIN AND THEIR BLOOD PRESSURE DROPPED. THE PHYSICIAN STARTED THE PACE MAKER THAT WAS ALREADY IN PLACE THROUGH THE VENOUS ACCESS SHEATH. THE NAV6 FILTER WAS REMOVED WITHOUT ISSUES AND THE CASE WAS ABORTED. THE PATIENT SUFFERED A MILD STROKE AND WAS RUSHED TO COMPUTED TOMOGRAPHY AND STROKE PROTOCOLS WERE PUT IN PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED.