MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. (B)(4). ATTEMPTS WERE MADE TO GATHER THOROUGH EVENT INFORMATION DURING COMPLAINT PROCESSING; THE PHYSICIAN COMMENTED THAT THE ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH THE EVENT IS LESS LIKELY TO BE ATTRIBUTED TO RELEASE FOREIGN SUBSTANCE, THE POSSIBILITY CANNOT BE COMPLETELY DENIED. AS THE PATIENT WAS BEING ADMINISTERED A MEDICINE (STEROID), ITS SIDE EFFECT COULD BE CONSIDERED AS A CONTRIBUTORY FACTOR AS WELL. INVESTIGATION OF THE DEVICE COULD NOT BE CONDUCTED SINCE IT WAS NOT RETURNED. LOT HISTORY REVEALED NO ANOMALY RELATED TO THE REPORTED EVENT, AND NO OTHER SIMILAR PRODUCT EXPERIENCE OR PEELING OF COATING WAS REPORTED. BASED ON THE OBTAINED INFORMATION, IT IS PRESUMED THAT THERE WAS NO DEFICIENCY WITH THE DEVICE IN QUESTION AS THERE WAS NO ANOMALY FOUND IN THE PRODUCTION RECORD. THE LOT HISTORY DID NOT PRESENT ANY MALFUNCTION INFORMATION THAT COULD BE RELATED TO THIS EVENT. HOWEVER, AS THE DEVICE WAS NOT RETURNED, IT WAS CONCLUDED INVOLVEMENT OF THE DEVICE IN THE EVENT COULD NOT BE DENIED. MALFUNCTION AND ADVERSE EFFECTS SECTION OF THE IFU STATES: ALLERGIC REACTION.
D
Patient 1
ON (B)(6) 2016: COIL EMBOLIZATION WAS CONDUCTED TO AN UNRUPTURED LEFT INTIMAL CAROTID ARTERY ANEURYSM. ON (B)(6) 2016: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6), 2016: AT 2:40 PM, THE PATIENT WAS ADMITTED TO ER AFTER HAVING APHASIA AND SPASM. AT 5:15 PM, THE PATIENT BECAME ABLE TO UNDERSTAND INSTRUCTIONS AND TO RESPOND TO A VERBAL CONTACT. ON (B)(6) 2016: HEAD MRI AND ANGIOGRAPHIC HEAD MRI WERE CONDUCTED, AND EXPRESSION OF HIA (HIGH INTENSITY AREA) WAS CONFIRMED. OBSERVATION OF THE MRI IMAGE SUGGESTED THIS HIA COULD BE ATTRIBUTED TO AN INFLAMMATORY CHANGE DUE TO RELEASE OF FOREIGN SUBSTANCE INTO A PERIPHERAL VESSEL. ON (B)(6) 2016: THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2016: AT THE OUTPATIENT EXAMINATION, THE PATIENT HAD A CLEAR SENSORIUM, SHOWING NO SYMPTOM OF APHASIA OR SPASM. THE HIA THAT HAD BEEN CONFIRMED DURING THE PREVIOUS ADMISSION LOOKED DISAPPEARED, BUT A NEW HIA EXPRESSION WAS CONFIRMED AT THE LEFT FRONTAL LOBE. ON (B)(6) 2017: AT THE OUTPATIENT EXAMINATION MRI WAS CONDUCTED, BUT THE HIA LOOKED DISAPPEARED, INDICATING NO ANOMALY.