NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE

Description of Event or Problem

IT WAS REPORTED THAT IN A SUSPECTED RUPTURED DISSECTING ANEURYSM OF THE RIGHT A POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), A STENT-ASSISTED COILING PROCEDURE USING THE SUBJECT STENT WAS PERFORMED TO PRESERVE THE PICA. THE SUBJECT STENT WAS SUBSEQUENTLY DEPLOYED WITHOUT ISSUE. THE FIRST COIL WAS THEN DETACHED. DURING PLACEMENT OF A SECOND COIL, THE COIL MIGRATED OUTSIDE THE ANEURYSM, AND CONTRAST INJECTION CONFIRMED EXTRAVASATION. HEPARIN WAS IMMEDIATELY REVERSED, AND THE SECOND COIL WAS PLACED. THE THIRD COIL WAS THEN PLACED, AFTER WHICH EXTRAVASATION RESOLVED, AND PICA FLOW WAS PRESERVED. THE FOURTH COIL WAS SUBSEQUENTLY PLACED, WITH CONTINUED RESOLUTION OF EXTRAVASATION AND PRESERVATION OF PICA FLOW. UPON PLACEMENT OF A FIFTH COIL, AN EXTRAVASATION REMAINED RESOLVED; HOWEVER, LOSS OF PICA FLOW WAS OBSERVED, WHICH WAS CONSIDERED TO BE DUE TO THROMBUS FORMATION FOLLOWING HEPARIN REVERSAL. THE PROCEDURE WAS THEN CONCLUDED. CT (COMPUTED TOMOGRAPHY) IMAGING WAS PERFORMED, AND SPINAL DRAINAGE WAS PLANNED. DUAL ANTIPLATELET THERAPY (DAPT) IS PLANNED TO BE CONTINUED FROM THE FOLLOWING DAY. NO OTHER INFORMATION WAS PROVIDED.