THE COMPLAINT RECEIVED STATES THAT DURING RIGHT CAROTID ARTERY OCCLUSION, THERE WAS UNKNOWN NBCA LIQUID EMBOLIC KIT DISTAL EMBOLISATION WITH SUBSEQUENT CEREBRAL INFARCTION AND DEATH. THE TREATMENT FOR THE LEAKAGE WAS TO PLACE COILS IN THE TARGET RICA SITE AND THEN INJECT THE NBCA INTO THE COIL MASS TO STOP THE LEAKING. INITIAL COIL PLACEMENT WAS PERFORMED WITH MULTIPLE CORDIS COILS. POST COIL PLACEMENT AND GLUE INJECTION, ANGIOGRAPHY NOTED DISTAL EMBOLIZATION OF NBCA GLUE INTO THE RIGHT MIDDLE CEREBRAL ARTERY DISTRIBUTION. SECONDARY COIL PLACEMENT WAS PERFORMED WITH MULTIPLE COILS AND COMPLETE OCCLUSION WAS NOTED. SIGNIFICANT STROKE AND SUBSEQUENT DEATH WERE REPORTED POST PROCEDURE.
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Patient 1
AFTER INITIAL COIL PLACEMENT, ANGIOGRAPHY REVEALED DISTAL FLOW PAST THE IMPLANTED COILS. THE PATIENT'S DATE OF DEATH WAS THREE YEARS AFTER, EXACT DATE NOT KNOWN. THE PATIENT HAD A LONG COMPLICATED COURSE BEFORE AND AFTER THE PROCEDURE. HE HAD FAILED A FULL DOSE OF CHEMOTHERAPY AND RADIATION THERAPY AT ANOTHER ACADEMIC INSTITUTION (TUMOR HAD PROGRESSED DESPITE TREATMENT) AND CAME TO ANOTHER FACILITY FOR A SECOND OPINION AFTER BEING OFFERED PALLIATIVE CARE. HE WAS OFFERED "RE-IRRADIATION" OR A SECOND FULL DOSE OF RADIATION THERAPY. IT'S A SOMEWHAT INVESTIGATIONAL TREATMENT. HE HAS LOTS OF FOLLOW UP RECORDS FROM MANY HOSPITALS, INCLUDING A SUBSEQUENT BLEED FROM HIS RIGHT EXTERNAL CAROTID ARTERY. THE PRODUCT REMAINS IMPLANTED, THUS IS UNAVAILABLE FOR ANALYSIS; FURTHER, NO STERILE LOT NUMBER INFORMATION IS AVAILABLE AND NO DHR CAN BE PERFORMED. CATALOGUE NUMBER 631XXX IS BEING USED BECAUSE THE ACTUAL CATALOGUE NUMBER IS UNAVAILABLE. EMBOLISATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH LIQUID GLUE ASSISTED PROCEDURES AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR USE, THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PROCEDURAL AND ANATOMIC ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. ADD'L MEDICAL DEVICES: 5F WEINBERG CATHETER, MEDITECH OCCLUSION BALLOON CATHETER, PROWLER 14 MICROCATHETER.