UNKNOWN_NEUROVASCULAR_PRODUCT

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 STENT WAS PERFORMED TO PRESERVE THE PICA. THE STENT WAS SUBSEQUENTLY DEPLOYED WITHOUT ISSUE. THE FIRST COIL WAS THEN DETACHED. DURING PLACEMENT OF A SECOND COIL (SUBJECT DEVICE), THE SUBJECT 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 STENT 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. ADDITIONAL INFORMATION RECEIVED ON 16-JUN-2026 STATED THAT THE PORTION OF THE COIL (SUBJECT DEVICE) THAT HAD PROTRUDED OUTSIDE THE ANEURYSM WAS PARTIALLY MANAGED BY ADJUSTING THE MICROCATHETER TIP WITHIN THE ANEURYSM, AND THE REMAINING COIL WAS FULLY DEPLOYED WITHIN THE ANEURYSM. AS A STENT HAD BEEN PLACED, THE COIL (SUBJECT DEVICE) WAS SUCCESSFULLY SECURED WITHIN THE ANEURYSM. FOLLOW-UP ASSESSMENT SHOWED THAT ALTHOUGH INITIAL DISAPPEARANCE OF THE PICA WAS OBSERVED IMMEDIATELY AFTER THE PROCEDURE, IT GRADUALLY REAPPEARED UNDER SEDATION AND ANTICOAGULATION MANAGEMENT, LIKELY DUE TO A WASHOUT EFFECT, WITH RESOLUTION OF THE ANEURYSM ALSO OBSERVED. NO INFARCTION IN THE CEREBELLUM WAS NOTED. THE PATIENT IS CURRENTLY BEING PLANNED FOR SHUNT SURGERY FOR HYDROCEPHALUS. THE ATTENDING PHYSICIAN ALSO STATED THAT THE PATIENT¿S CONDITION IS EXPECTED TO IMPROVE.

Additional Manufacturer Narrative

THIS IS A SECOND MDR REPORT REGARDING THE TARGET TETRA COIL.