ONYX
Report
- Report Number
- 2029214-2022-00478
- Event Type
- Injury
- Date Received
- March 25, 2022
- Date of Event
- July 2, 2020
- Report Date
- June 22, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
CHANG KI JANG, BYUNG MOON KIM, KEUN YOUNG PARK, JAE WHAN LEE, DONG JOON KIM, JOONHO CHUNG, JUN-HWEE KIM; BMC NEUROLOGY; 2021; 21:31; SCEPTER DUAL-LUMEN BALLOON CATHETER FOR ONYX EMBOLIZATION FOR DURAL ARTERIOVENOUS FISTULA; DOI.ORG/10.1186/S12883-021-02046-6. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENT'S WHO RECEIVED TREATMENT WITH ONYX HAD COMPLICATIONS. TRANSARTERIAL ONYX EMBOLIZATION USING A SCEPTER DUAL-LUMEN BALLOON CATHETER (SCEPTER-ASSISTED ONYX EMBOLIZATION)FOR DURAL ARTERIOVENOUS FISTULA (DAVF WAS ATTEMPTED IN A TOTAL OF 35 PATIENTS (MEAN AGE, 52.5 YEARS; M:F = 24:11) BETWEEN OCTOBER 2012 AND DECEMBER 2018 WAS STUDIED. IF IT HAD BEEN ONE OF THE FEEDERS OF DAVF, MIDDLE MENINGEAL ARTERY WAS PREFERENTIALLY SELECTED FOR ONYX EMBOLIZATION. FOR OVERCOMING THE DIFFICULTY, IF ANY, IN NAVIGATION OF THE SCEPTER BALLOON CATHETER, THE FOLLOWING TECHNIQUES WERE USED. THE TIP OF SCEPTER BALLOON CATHETER WAS ALMOST ALWAYS STEAM-SHAPED FOR IMPROVING NAVIGABILITY. THE DISTAL ACCESS CATHETER HAS ALWAYS BEEN USED COMBINED WITH A SHUTTLE 6F SHEATH FOR MORE SUPPORTING THE SCEPTER BALLOON CATHETER. IF NEEDED, EXCHANGE TECHNIQUE WAS EMPLOYED FOR PLACING THE SCEPTER BALLOON CATHETER INTO THE TARGET POINT OF THE FEEDING ARTERY USING A MICROCATHETER WITH INNER LUMEN OF 0.0165-INCH AND A 300-CM LENGTH, 0.014-INCH EXCHANGEABLE MICROWIRE (TRANSEND, STRYKER). IN DETAIL OF EXCHANGE TECHNIQUE, A 0.0165-INCH MICROCATHETER WAS NAVIGATED TO THE TARGET POINT OF THE FEEDING ARTERY. FINALLY, SCEPTER BALLOON CATHETER WAS ADVANCED OVER THE EXCHANGE WIRE. IN ADDITION, VASODILATOR (NIMODIPINE, 0.3¿0.5 MG) WAS INFUSED INTO THE FEEDING ARTERY BEFORE THE NAVIGATION OF SCEPTER CATHETER TO PREVENT VASOSPASM. THE ESSENTIAL PREREQUISITE OF THE TARGET POSITION OF THE SCEPTER BALLOON CATHETER WITHIN THE FEEDING ARTERY IS T HAT THERE IS NO FUNCTIONING ARTERIAL BRANCH ARISING BETWEEN THE POINT AND THE FISTULA. INITIAL PRESENTATIONS WERE NON-HEMORRHAGIC NEUROLOGICAL DEFICITS IN 10, INTRACRANIAL HEMORRHAGE IN 8, SEIZURE IN 7, HEADACHE IN 7, AND INTRACTABLE TINNITUS IN 3. ALL DAVF WERE AGGRESSIVE TYPE; BORDEN TYPE 2, 5 (14.3 %) AND TYPE 3, 30 (85.7 %), RESPECTIVELY. SCEPTER-ASSISTED ONYX EMBOLIZATION RESULTED IN IMMEDIATELY COMPLETE OCCLUSION IN 33 PATIENTS AND NEAR COMPLETE OCCLUSION IN 2 PATIENTS. COMPLICATIONS OCCURRED IN 2 PATIENTS, OF WHOM ONE HAD A PERMANENT MORBIDITY (2.8 %, IPSILATERAL FACIAL NERVE PALSY). ONE PATIENT PRESENTED WITH INTRACTABLE RIGHT FACIAL SPASM DUE TO NEUROVASCULAR COMPRESSION FROM THE ENGORGED DRAINING VEIN OF THE DAVF AT RIGHT SUPERIOR PETROSAL SINUS. THE PATIENT EXPERIENCED RIGHT FACIAL PALSY AFTER ONYX EMBOLIZATION, LIKELY DUE TO PENETRATION OF ONYX INTO THE PETROUS BRANCH, WHICH SUPPLIES THE PETROUS SEGMENT OF THE FACIAL NERVE VIA ARTERY-TO-ARTERY ANASTOMOSIS. THE OTHER PATIENT EXPERIENCED A TRANSIENT CONTRALATERAL SENSORY CHANGE BUT COMPLETELY RECOVERED IN A WEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1128818 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Disability |