SURPASS ELITE FDS 5.25MM X 50MM - PMAS

Description of Event or Problem

IT WAS REPORTED THAT, ON (B)(6) 2025 THE PATIENT WAS ADMITTED AND THE STENT (SUBJECT DEVICE) WAS DEPLOYED BETWEEN 2 NON-STRYKER FLOW DIVERTER DEVICES THAT WERE FOUND TO BE SEPARATED WITHIN THE PATIENT AND FREE FLOATING WITHIN AN ANEURYSM. THE PHYSICIAN DEPLOYED THE SUBJECT DEVICE SUCCESSFULLY AND THE FLOW WAS DIVERTED FROM THE FUSIFORM ANEURYSM. HOWEVER, THE SAME PATIENT WAS REPORTED WITH STROKE ON (B)(6) 2026 AND THE PRESENCE OF IN STENT STENOSIS WAS CONFIRMED ON (B)(6) 2026. THE PHYSICIAN PERFORMED THROMBECTOMY ON (B)(6) 2026 AND WAS NOT DOING WELL AFTER OBTAINING REPERFUSION. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS UNSURE, AND IT WOULD BE HARD TO PINPOINT THIS ON THE SUBJECT DEVICE. THE PATIENT HAS HAD A PRIOR STROKE IN THE BASILAR, AND THE SPECIFIC THE PHYSICIAN TOOK PART IN WAS A VERY COMPLEX AND CHALLENGING ONE. A SURGICAL DELAY OF MORE THAN 180 MINUTES WAS REPORTED.