AXIUM

Report

Report Number: 2029214-2023-02217
Event Type: Death
Date Received: November 15, 2023
Date of Event: December 13, 2022
Report Date: November 15, 2023
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3
Product Code: HCG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

ZHOUYANG ZHAO, QINMING LIAO, YIMEI YANG, YUE MA, XIAOMENG LU, QIANHUI QIU, FEI HAN, LIJIN HUANG; HEAD AND NECK; 2023; 45:1875¿1884; SURVIVAL ANALYSIS OF A COMPREHENSIVE TREATMENT STRATEGY FOR INTERNAL CAROTID ARTERY BLOWOUT SYNDROME BY NASOPHARYNGEAL CARCINOMA; DOI: 10.1002/HED.27393. MEDTORNIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENT TREATED WITH AXIUM COILS HAVING COMPLICATIONS. THE OBJECTIVE OF THE ARTICLE WAS TO RETROSPECTIVELY ANALYZE THE COMPREHENSIVE TREATMENT STRATEGY FOR INTERNAL CAROTID ARTERY BLOWOUT SYNDROME (CBS) BY NASOPHARYNGEAL CARCINOMA (NPC). 311 PATIENTS OF NPC WITH CAROTID ARTERY BLOWOUT SYNDROME ADMITTED AT THE STUDY CENTER FROM APRIL 2018 TO AUGUST 2022, 288 WERE ENROLLED. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: TREATMENT GROUP (266 CASES) AND CONTROL GROUP (22 CASES). THE CONTROL GROUP, INCLUDING PATIENTS, REFUSED ENDOVASCULAR TREATMENT AND REQUESTED FOR NASAL ENDOSCOPY TREATMENT (NECESSARY NASAL PACKING/ELECTROCOAGULATION FOR EPISTAXIS AND REGULAR NASOPHARYNGOSCOPY RECHECK). FOR NPC PATIENTS WITH : ASITN/SIR, AMERICAN SOCIETY OF INTERVENTIONAL NEURORADIOLOGY/SOCIETY OF INTERVENTIONAL RADIOLOGY (ASITN/SIR) GRADE 4 AND ASITN/ SIR GRADE 3 WITH OBVIOUS POSTERIOR COMMUNICATING ARTERY (PCOMA) COMPENSATION, THEY CHOSE COILS OCCLUSION. THE GRADING SCALE IS A SIMPLE EVALUATION METHOD TO EVALUATE THE COMPENSATION OF THE CIRCLE OF WILLIS THROUGH DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). LOCAL ANESTHESIA AND PUNCTURE OF THE RIGHT FEMORAL ARTERY WERE PERFORMED BY USING AN 8F SHEATH (TERUMO). THE 8F MERCI BALLOON CATHETER (MERCI 95CM) WAS GUIDED TO THE AFFECTED INTERNAL CAROTID ARTERY (ICA), THEN THE BALLOON WAS INFLATED (0.2¿0.6 ML). MULTIPLE COILS (AXIUM AND TORNADO) WERE INTRODUCED THROUGH THE MICROCATHETER (MIRAFLEX 2.5F). NOTE THAT THE REGION OF COILS OCCLUSION SHOULD COMPLETELY COVER THE PROXIMAL AND DISTAL ENDS OF THE ICA LESIONS UNTIL THE BLOOD FLOW WAS COMPLETELY OCCLUDED. FINALLY, THE CEREBRAL ARTERIAL HEMODYNAMICS FULLY COMPENSATED, WITHOUT VASCULAR LOSS, WAS CONFIRMED BY ANGIOGRAPHY. FOR THREATENED AND IMPENDING CBS, WE RECOMMEND THE DIRECTLY COILS OCCLUSION OR COILS OCCLUSION AFTER EXTRA-INTRACRANIAL VASCULAR BYPASS. FOR ACUTE CBS, WE PREFER TO IMPLANT OF COVERED STENTS. THE STENTS SELECTED ARE DIFFERENT ACCORDING TO THE LOCATION OF CBS. IF THE LESION IS LOCATED FROM THE CAVERNOUS SINUS SEGMENT TO THE PETROUS SEGMENT, THEY CHOOSE WILLIS COVERED STENT (WILLIS) WITH APPROPRIATE PARAMETERS ACCORDING TO THE MEASUREMENT OF VESSEL DIAMETER, INTRODUCE THE 8F MERCI BALLOON CATHETER TO THE AFFECTED ICA THROUGH AN 8F SHEATH, BLOCK POSITIVE BLOOD FLOW OF ICA AND GUIDE THE WILLIS COVERED STENT WITH THE SINGLE MICROWIRE (SYNCHRO-14 MICROWIRE 200CM) TECHNIQUE TO THE LESION AREA. CONFIRM THE POSITION, RELEASE THE STENT, PERFORM ANGIOGRAPHY TO CONFIRM THE EFFECT. RESULTS: GIVEN THE PREVALENCE OF ANEMIA AND MALNUTRITION IN PATIENTS WITH NPC-CBS, THEY EVALUATED THE HEMOGLOBIN AND SERUM ALBUMIN LEVELS OF THE PATIENTS AT ADMISSION AND FOUND THAT THE CONTENT OF SERUM ALBUMIN OF TREATMENT GROUP WAS SIGNIFICANTLY LOWER THAN HAT OF THE CONTROL GROUP, WHILE HAD NOT DIFFERENCE IN HEMOGLOBIN. WHAT'S MORE, THE DISTRIBUTION OF AGE AND SEX WAS BASICALLY THE SAME BETWEEN TWO GROUPS. THEY FURTHER EVALUATED THE STATUS OF THE TUMOR. THE PROPORTION OF TUMOR NODE METASTASIS (TNM) STAGES IN THE TREATMENT GROUP AND CONTROL GROUP WAS BASICALLY THE SAME, AND THERE WAS NO STATISTICAL DIFFERENCE. NOTICEABLY, THE TUMOR STAGES OF RTNM IVA AND CTNM IVA ACCOUNTED FOR THE MAJORITY. IMAGING MANIFESTATIONS OF CBS IN NPC WERE AS FOLLOWS: ANEURYSMS OR PSEUDOANEURYSMS, POST-RADIATION NASOPHARYNGEAL NECROSIS, RADIOACTIVE BONE INJURY, 180¿360 OF TUMOR ENCASEMENT TO CAROTID, AND CAROTID ARTERY EXPOSURE. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE IMAGING MANIFESTATIONS BETWEEN THE TWO GROUPS. THEY PROVIDED AIRWAY PROTECTION TO THE TREATMENT GROUP AND CONTROL GROUP UNDER THE SAME STANDARDS, WHICH HAD IMPORTANT EFFECTS IN PREVENTING ASPHYXIA CAUSED BY EPISTAXIS IN PRACTICAL WORK. ALTHOUGH THERE WERE SEVERAL PATIENTS IN THE TREATMENT GROUP EXPERIENCED STROKE DURING HOSPITALIZATION, THERE WAS NO SIGNIFICANT DIFFERENCE IN STROKE BETWEEN THE TWO GROUPS DURING LONG-TERM FOLLOW-UP. AT THE SAME TIME, THEY FOLLOWED UP AND OBSERVED THE SURVIVAL STATUS, AND FOUND THAT THE OVERALL SURVIVAL RATE OF TREATMENT GROUP WAS SIGNIFICANTLY HIGHER THAN THAT OF THE CONTROL GROUP, ESPECIALLY WITHIN 6 MONTHS TO 1 YEAR. IN ORDER TO EXPLORE THE DETAILS IN DIFFERENT ILLNESS STATUS, THEY FURTHER DIVIDED THE TREATMENT GROUP AND CONTROL GROUP INTO THREATENED CBS SUBGROUP (CBS I), IMPENDING CBS SUBGROUP (CBS II), AND ACUTE CBS SUBGROUP (CBS III). THEY FOUND THAT THERE WAS NO SIGNIFICANT DIFFERENCE IN THE 3-YEAR SURVIVAL RATE OF CBS I TYPE BETWEEN THE TWO GROUPS, BUT FOR CBS II TYPE, THE 1-YEAR SURVIVAL RATE IN THE TREATMENT GROUP WAS SIGNIFICANTLY HIGHER. DUE TO THE SMALL SAMPLE SIZE OF CBS III TYPE IN THE CONTROL GROUP, THEY HAVE NOT CONDUCTED FURTHER RESEARCH. IN ADDITION, THE STROKE RATE OF CBS I PATIENT IN CONTROL GROUP WAS SIGNIFICANTLY HIGHER THAN TREATMENT GROUP. HERE, GIVEN THE SMALL NUMBER OF CASES IN THE CONTROL GROUP, THEY DID NOT CLASSIFY THEM INTO DIFFERENT CBS SUBTYPES AND SIMPLY OBSERVE THE DIFFERENCES OF SURVIVAL RATES IN CONTROL GROUP COMPARED TO THE DIFFERENT CBS SUBTYPES OF TREATMENT GROUP. THEY COULD DRAW A GENERAL CONCLUSION THAT THE SURVIVAL RATES OF THE THREE CBS SUBTYPES IN THE TREATMENT GROUP WERE GENERALLY HIGHER THAN THOSE IN THE CONTROL GROUP, AND WERE MORE PROMINENT WITHIN 6 MONTHS. FROM A LONG-TERM PERSPECTIVE, THE CBS I TYPE IN THE TREATMENT GROUP MAY HAVE A RELATIVELY BETTER PROGNOSIS. THE TREATMENT GROUP SURVIVAL RATE WAS 264/266 AT 30 DAYS AND 206/266 AT 3 YEARS. THE CONTROL GROUP SURVIVAL RATE WAS 21/22 AT 30 DAYS AND 13/22 AT 3 YEARS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
906115	AXIUM	DEVICE, NEUROVASCULAR EMBOLIZATION	HCG	MICRO THERAPEUTICS, INC. DBA EV3	UNK-NV-AXIUM	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death