UNKNOWN_NEUROVASCULAR_PRODUCT

Description of Event or Problem

IN A LITERATURE ARTICLE TITLED, "EARLY EXPERIENCE WITH TARGET TETRA COILS FOR TREATMENT OF SMALL AND VERY SMALL RUPTURED INTRACRANIAL ANEURYSMS", ALL ANEURYSMS WERE TREATED USING TARGET TETRA DETACHABLE COIL TTDC OR A COMBINATION OF TTDC AND ADDITIONAL COILS AS DEEMED NECESSARY BY THE OPERATOR FOR ANEURYSM OCCLUSION. THIS STUDY IS A RETROSPECTIVE SINGLE-CENTER COHORT ANALYSIS OF PATIENTS WITH RUPTURED INTRACRANIAL SACCULAR ANEURYSMS UNDER 5 MM IN MAXIMUM DIAMETER, TREATED ENDOVASCULARLY WITH TDC BETWEEN 2023 AND 2025. PATIENTS WHO WERE TREATED PRIMARILY WITH ANOTHER COIL TYPE WERE EXCLUDED. PROCEDURAL COMPLICATIONS OCCURRED IN 13.9% (FIVE CASES), INCLUDING INTRAPROCEDURAL PERFORATION (N=2; 5.6%). INTRAPROCEDURAL PERFORATIONS: IN THE FIRST CASE WITH INTRAPROCEDURAL PERFORATION, CONTRAST EXTRAVASATION WAS NOTED ON FOLLOW-UP ANGIOGRAPHY AFTER PLACING THE FINAL COIL. PROTAMINE WAS ADMINISTERED IMMEDIATELY AND A BALLOON WAS ADVANCED INTO THE PRECEDING A1 SEGMENT AND WAS INFLATED AND REMAINED INFLATED UNTIL NO FURTHER CONTRAST EXTRAVASATION WAS SEEN. FOLLOW-UP FLAT PANEL CT DEMONSTRATED STABLE VENTRICULAR SIZE WITH SMALL VOLUME CONTRAST EXTRAVASATION IN BASAL CISTERNS. THIS PATIENT WAS THEN ADMITTED TO THE NEUROSCIENCES CRITICAL CARE UNIT (NSICU) AND UNDERWENT STANDARD ASAH MANAGEMENT. SHE HAD AN EXCELLENT SUBSEQUENT CLINICAL COURSE AND WAS DISCHARGED HOME. THE SECOND PATIENT WITH INTRAPROCEDURAL PERFORATION WAS NOTED TO HAVE CONTRAST EXTRAVASATION AFTER PLACEMENT OF THE FOURTH COIL. THE BALLOON MICROCATHETER, WHICH WAS POSITIONED IN THE A1 SEGMENT PROXIMAL TO THE ANEURYSM WAS INFLATED AND AFTER SOME TIME WAS DEFLATED, WITH FOLLOW-UP ANGIOGRAPHY DEMONSTRATING NO FURTHER CONTRAST EXTRAVASATION. FOLLOW-UP FLAT PANEL CT DEMONSTRATED SMALL VOLUME CONTRAST IN THE BASAL CISTERNS, AND THIS PATIENT ALSO HAD AN EXCELLENT NEUROLOGICAL OUTCOME, WITH DISCHARGE HOME AFTER STANDARD NSICU POST-ASAH CARE. ALTHOUGH OUR STUDY REPORTED A SLIGHTLY HIGHER RATE OF INTRAPROCEDURAL RUPTURE THAN THE ULRA REGISTRY, BOTH RUPTURES WERE EASILY CONTROLLED AND THEY TOOK PLACE IN LIKELY THIN-WALLED COMPLEX ANEURYSMS THAT WERE HIGHLY PRONE TO RUPTURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS, IF ANY. THEREFORE, THIS REPORT ADDRESSES ALL PERFORATION EVENTS COVERED WITHIN THIS LITERATURE SOURCE.

Additional Manufacturer Narrative

THIS IS 2/2 MDRS.