ONYX
Report
- Report Number
- 2029214-2023-01325
- Event Type
- Malfunction
- Date Received
- August 8, 2023
- Date of Event
- February 28, 2006
- Report Date
- August 8, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT RELATED TO REGULATORY REPORTS: 2029214-2023-01323 & 2029214-2023-01324. 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.
C. MOUNAYER, N. HAMMAMI, M. PIOTIN, L. SPELLE, G. BENNDORF, I. KESSLER AND J. MORET; AJNR. AMERICAN JOURNAL OF NEURORADIOLOGY; 2007; 28 (3) 518-523; NIDAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS USING ONYX IN 94 PATIENTS; ISSN: 01956108 NLM ISO MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS TREATED WITH ONYX HAS COMPLICATIONS INCLUDING DEATH. THE PURPOSE OF THE ARTICLE WAS TO REPORT AN EXPERIENCE IN THE TREATMENT OF BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS) USING ONYX. FROM JANUARY 1999 TO OCTOBER 2004, 94 PATIENTS WITH BAVMS WERE TREATED ENDOVASCULARLY AT ONE FACILITY. THEY WERE 51 (54%) MEN AND 43 (46%) WOMEN WITH A MEAN AGE OF 32 YEARS. A TOTAL OF 210 ENDOVASCULAR PROCEDURES WERE PERFORMED WITH ONYX AS THE SOLE EMBOLIC AGENT IN 88 PROCEDURES; ONYX AND N-BUTYL CYANOACRYLATE (N-BCA) WERE USED IN COMBINATION IN 50 PROCEDURES, AND N-BCA ALONE WAS USED IN 72 PROCEDURES. PROCEDURE: A BRAIN CT SCAN WAS OBTAINED BEFORE AND AFTER EACH EMBOLIZATION. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA. AN INTRAVENOUS BOLUS OF 3000 IU OF HEPARIN WAS GIVEN TO EACH PATIENT. THEN, A 6F SHEATH WAS PLACED IN ONE OF THE FEMORAL ARTERIES. A 3-VESSEL CEREBRAL ANGIOGRAPHY WAS PERFORMED, AND A 6F GUIDING CATHETER WAS THEN INSERTED IN EITHER AN INTERNAL CAROTID OR A DOMINANT VERTEBRAL ARTERY THAT GAVE THE BEST SUPPLY TO THE BAVM. IF THE LESION WAS SUPPLIED BY 2 VASCULAR TERRITORIES (EG, A POSTERIOR TEMPORAL BAVM SUPPLIED BY FEEDERS FROM THE POSTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES), A 5F DIAGNOSTIC CATHETER WAS INSERTED WITHIN THE COLLATERAL TERRITORY TO BE ABLE TO CONTROL THE WHOLE ARTERIAL SUPPLY DURING THE EMBOLIZATION. ONCE MICROCATHETERIZATION AS THE CLOSE AS POSSIBLE TO THE NIDUS WAS ACHIEVED, A NONSUBTRACTED SINGLE-SHOT IMAGE OF THE MICROCATHETER WITH THE GUIDEWIRE INSIDE WAS OBTAINED WHEN CATHETERIZING THE FEEDING PEDICLE TO HAVE A TRACE OF THE MICROCATHETER TRAJECTORY AND TO BE ABLE TO CONTROL PRECISELY THE ONYX REFLUX WITHIN THE FEEDER. THE GUIDEWIRE WAS THEN PULLED OUT. THE DECISION WHETHER TO USE ONYX WAS MADE ACCORDING TO VARIOUS CRITERIA BASED ON THE RESULTS OF THE SUPRASELECTIVE ARTERIOGRAM. FIRST, THE TIP OF THE MICROCATHETER HAD TO BE AS CLOSE AS POSSIBLE TO THE NIDUS, MEANING THAT THE FEEDING ARTERIAL PEDICLE WAS NAVIGATED DISTALLY UP TO THE NIDAL NETWORK. SECOND, THE FEEDING PEDICLE HAD TO BE OCCLUDED UP TO 1.5 CM RETROGRADELY BY THE REFLUX OF ONYX ALONG THE MICROCATHETER. FINALLY, IFA DIRECT ARTERIOVENOUS SHUNT WAS DISCLOSED ON THE SUPRASELECTIVE ANGIOGRAPHY BEFORE THE EMBOLIC AGENT INJECTION, ONYX WAS NOT USED SO AS TO AVOID MIGRATION INTO THE DRAINING VEIN. IF THESE CRITERIA WERE MET, THE MICROCATHETER WAS FLUSHED WITH DMSO AND THE DEAD SPACE OF THE MICROCATHETER WAS SLOWLY FILLED WITH ONYX OVER A PERIOD OF APPROXIMATELY 40 SECONDS (A DURATION OF 40 SECONDS WAS CHOSEN TO AVOID A DIMETHYL-SULFOXIDE (DMSO) BOLUS IN THE CEREBRAL CIRCULATION). THEN ONYX WAS SLOWLY AND PROGRESSIVELY INJECTED INTO THE NIDUS UNDER CONTINUOUS VISUAL CONTROL USING BIPLANE SUBTRACTED FLUOROSCOPY. BECAUSE OF ITS LOW VISCOSITY, ONYX HAD A PROPENSITY TO MIGRATE DISTALLY, PENETRATING DEEPLY INTO THE NIDUS. AS SOON AS REFLUX ALONG THE MICROCATHETER WAS OBSERVED, THE INJECTION WAS STOPPED FOR A FEW MINUTES AND THEN RESUMED. ALTHOUGH IN PRINCIPLE, A DRAINING VEIN COULD BE COMPLETELY OCCLUDED ONLY WHEN THE NIDUS WAS COMPLETELY FILLED WITH THE EMBOLIC AGENT. WHEN PASSING THROUGH A VEIN, ONYX TENDED TO INITIALLY LAMINATE ALONG THE VENOUS WALL. THE OVERALL LENGTH OF THE INJECTION DEPENDED ON THE AMOUNT OF REFLUX, ASSESSED BY LENGTH OF THE EMBOLIC AGENT COLUMN IN THE FEEDING PEDICLE. THE MAXIMUM REFLUX CONSIDERED TOLERABLE BY OUR GROUP IS 1.5 CM. IN THIS SERIES, THE DURATION OF ONYX INJECTIONS RANGED FROM 3 TO 72MINUTES (MEAN, 24 MINUTES). ITERATIVE BIPLANAR ANGIOGRAPHIES WERE PERFORMED VIA THE GUIDING CATHETER WHILE INJECTING THE POLYMER. THE PROCEDURE WAS ENDED WHEN THE LENGTH OF REFLUX WAS CONSIDERED CRITICAL (1.5 CM) OR WHEN ANGIOGRAPHY SHOWED THE TOTAL EMBOLIZATION OF THE NIDUS WITHOUT VENOUS STAGNATION. RESULTS: ONE PATIENT HAD OPHTHALMOPGIA CAUSED BY ONYX. ANOTHER PATIENT HAD TRANSIENT DIPLOPIA CAUSED BY ONYX/M-BCA. ANOTHER PATIENT HAD TRANSIENT RIGHT HEMIPARESIS CAUSED BY ONYX. ONE DEATH WAS CAUSED BY THE PROCEDURE. TWO OTHER DEATHS WAS UNRELATED TO ONYX BUT RATHER N-BCA PR N-BCA CATHETERIZATION. IN ALL TREATMENT TYPES, AFTER A TOTAL OF 210 PROCEDURES IN 94 PATIENTS, THE NEUROLOGIC STATUS WAS UNCHANGED OR HAD IMPROVED IN 80 (85%, 80/94) PATIENTS. WE OBSERVED TREATMENT-RELATED NEUROLOGIC DEFICIT IN 11 (12%, 11/94) PATIENTS. THE DEFICITS WERE PERMANENT IN 8 PATIENTS (9%, 8/94). THREE (3%, 3/94) PATIENTS DIED IN RELATION TO THE TREATMENT. UNCONTROLLABLE BLEEDING DURING SURGICAL RESECTION OF A TEMPORAL BAVM REMNANT CAUSED ONE DEATH, ANOTHER RESULTED FROM AN ARTERIAL PERFORATION DURING BAVM CATHETERIZATION, AND THE LAST WAS CAUSED BY A HEMORRHAGE AS A RESULT OF PREMATURE OCCLUSION OF THE DRAINING VEIN WITH N-BCA. OF 88 PROCEDURES USING ONYX ONLY, 2 PERMANENT NEUROLOGIC DEFICITS WERE RELATED TO THE PROCEDURE (2.5%, 2/94). ONE WAS A HEMORRHAGIC AND THE OTHER AN ISCHEMIC COMPLICATION OCCURRING WITHIN 48 HOURS AFTER THE PROCEDURE. OF 72 PROCEDURES PERFORMED USING N-BCA ALONE, THERE WERE 5 PERMANENT NEUROLOGIC DEFICITS (7%, 5/72), 3 HEMORRHAGIC AND 2 ISCHEMIC COMPLICATIONS. IN 50 PROCEDURES PERFORMED USING A COMBINATION OF N-BCA AND ONYX, 1 PERMANENT ISCHEMIC DEFICIT AND 1 DEATH OCCURRED. BOTH WERE RELATED TO A BLEEDING OF THE BAVM, IDENTIFIABLE ON THE PERIPROCEDURAL ANGIOGRAM AFTER NBCA INJECTION. NO SYSTEMIC (AFFECTING BLOOD PRESSURE OR CARDIAC RHYTHM) OR LOCAL (VASOSPASM OR THROMBOSIS OF THE EMBOLIZED VESSEL) SIDE EFFECTS RELATED TO THE DMSO INJECTION WERE OBSERVED. TRAPPING OF THE CATHETER TIP OCCURRED DURING 4 EMBOLIZATION USING ONYX, WITHOUT CLINICAL CONSEQUENCES. IN 3 OF THESE CASES, THE MICROCATHETER WAS BROKEN, AND IN THE OTHER, IT WAS INTENTIONALLY LEFT IN PLACE BECAUSE OF THE LONG INJECTION TIME AND THE LENGTH OF THE REFLUX. NO CATHETER WAS GLUED DURING N-BCA INJECTIONS. DISTAL RUPTURE OF THE ARTERIAL FEEDER DURING CATHETERIZATION OCCURRED IN 5 PATIENTS. THE RUPTURE WAS ANGIOGRAPHICALLY APPARENT DURING THE PROCEDURE AND THE RUPTURE SITE WAS IMMEDIATELY OCCLUDED WITH N-BCA WITHOUT CLINICAL SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324488 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Male |