Description of Event or Problem · 1
APPROXIMATELY (B)(6) WOMAN WAS BEING TREATED FOR AN UN-RUPTURED LEFT SIDE MCA (ELECTIVE CASE), WHICH WAS ASYMPTOMATIC. DURING THE CASE, THE NAVIGATION, POSITIONING AND DEPLOYMENT WERE ALL NORMAL AND AS EXPECTED. ANGIO RUN SHOWED THE POSITION OF THE DEVICE WAS OCCLUDING PARENT VESSEL, SO THE WEB WAS PARTIALLY RETRIEVED BACK INTO THE VIA 27 AND REDEPLOYED UNEVENTFULLY. ANOTHER ANGIO WAS RUN AND IT WAS EVIDENT THE DEVICE HAD DEPLOYED PARTIALLY INTO THE ANEURYSM AND PARTIALLY INTO THE SUBARACHNOID SPACE, HOWEVER NO BLEEDING WAS EVIDENT AS THE RUPTURE WAS SEALED BY THE WEB AND HAD STOPPED FLOW INTO THE SUBARACHNOID SPACE. THE PHYSICIAN DECIDED TO DETACH THE WEB AND AT THIS POINT THE PT HAD A REACTION (DROP IN BLOOD PRESSURE ETC.) AND ANOTHER ANGIO RUN CONFIRMED THAT THE WEB MOVED FURTHER INTO THE SUBARACHNOID SPACE, RESULTING IN MASSIVE SUBARACHNOID HEMORRHAGE. PT WAS ADMINISTERED PROTAMINE TO SLOW THE BLEED AND A STENT AND COILS WERE ALSO IMPLANTED. THE PT WAS TAKEN TO THE ICU WHERE A DRAIN WAS PLACED AND IS IN CURRENTLY IN CRITICAL CONDITION. THE PHYSICIAN INDICATED THE SYSTEM MOVED, MEANING THE CATHETERS, GUIDEWIRES, WEB BUT THIS WAS NOT DETECTED AND SO NO ADD'L ANGIO RUN WAS PERFORMED TO RE-VERIFY THE WEB POSITION. THE PHYSICIAN ALSO INDICATED THAT THE EVENT WAS NOT CAUSED BY ANY OF THE DEVICES IN THE CASE. SEQUENT MEDICAL WAS NOTIFIED ON (B)(6), 2015 THAT THE PT EXPIRED ON (B)(6), 2015.