ONYX
Report
- Report Number
- 2029214-2023-01310
- Event Type
- Injury
- Date Received
- August 7, 2023
- Date of Event
- February 20, 2021
- Report Date
- August 7, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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.
JIA-XING YU, CHUAN HE, MING YE, GUI-LIN LI, LI-SONG BIAN, FAN YANG, XIAO-DONG ZHAI, FENG LING, HONG-QI ZHANG. AND TAO HONG; BRIAN; 2021; 144; 3381¿3391; THE EFFICACY AND DEFICIENCY OF CONTEMPORARY TREATMENT FOR SPINAL CORD ARTERIOVENOUS SHUNTS; DOI:10.1093/BRAIN/AWAB237. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS POSSIBLY TREATED WITH ONYX HAVING COMPLICATIONS. THE PURPOSE OF THE ARTICLE WAS TO REVIEW THE CLINICAL COURSE OF THE LARGEST MULTICENTER COHORT TO EVALUATE THE EFFICACY AND DEFICIENCY OF CONTEMPORARY INTERVENTIONAL TREATMENTS FOR SPINAL CORD ARTERIOVENOUS SHUNTS (SCAVS). SCAVS LEADS TO SEVERE NEUROLOGICAL DEFICITS IN YOUNG PATIENTS. INCLUDED CONSECUTIVE PATIENTS WITH SCAVS WHO WERE ADMITTED TO CERTAIN FACILITIES IN CHINA BETWEEN JANUARY 2007 AND DECEMBER 2018. PATIENTS WERE ELIGIBLE IF THEY HAD BEEN SURGICALLY OR ENDOVASCULARLY TREATED IN OUR INSTITUTES AND THE INTRADURAL ARTERIOVENOUS SHUNT (AVS) LOCATION RANGED FROM THE ATLAS TO THE TIP OF THE CONUS MEDULLARIS. A TOTAL OF 548 SCAVS PATIENTS WERE INCLUDED, 463 (84.5%) OF WHOM, WITH LONG-TERM FOLLOW-UP DATA, WERE ELIGIBLE FOR FURTHER ANALYSIS. FOUR HUNDRED AND SIXTY PATIENTS WERE SYMPTOMATIC AND HAD A MEDIAN ONSET AGE OF 23 YEARS. TREATMENT: TREATMENT OPTIONS INCLUDED EMBOLIZATION AND MICROSURGERY ALONE OR IN COMBINATION BASED ON THE ANGIO-ARCHITECTURE. THE END OVASCULAR EMBOLIZATION WAS THE PRIORITIZED TREATMENT IF THE NEURORADIOLOGIST PREDICTED THAT THE ARTERIAL ROUTE AND THERAPEUTIC SAFETY WERE FAVORABLE. EXCEPT FOR PATIENTS WHO COULD NOT CO-OPERATE, ENDOVASCULAR PROCEDURES WERE PERFORMED WITH THE PATIENTS UNDER LOCAL ANAESTHESIA SO THAT THE PROPOFOL TEST COULD BE PERFORMED WHEN NECESSARY. GLUE [N-BUTYLCYANOACRYLATE (NBCA)] WAS THE MAIN EMBOLIC AGENT BUT WAS USED ONLY WHEN THE MICROCATHETER COULD REACH THE AVS DISTAL ENOUGH TO AVOID OBLITERATION OF THE NORMAL SPINAL SUPPLY. PARTICULATE EMBOLIZATION WAS PERFORMED WHEN THE MICROCATHETER COULD NOT REACH THE SHUNTS. COILS WERE USED FOR ANEURYSMAL STRUCTURES AND VENOUS POUCHES. ETHYLENE-VINYL ALCOHOL COPOLYMER (ONYXVR) WAS USED EXCLUSIVELY FOR EXTRADURAL AVSS OF SPINAL METAMERIC ARTERIOVENOUS SHUNTS (SMAVSS). IF ENDOVASCULAR TREATMENT COULD NOT COMPLETELY OBLITERATE THE AVSS AND THE NEUROSURGEON PREDICTED THAT THE LESION WAS SURGICALLY ACCESSIBLE, MICROSURGERY WAS PERFORMED WITH THE GOAL OF COMPLETE RESECTION. MOTOR-EVOKED POTENTIAL AND SOMATOSENSORY-EVOKED POTENTIAL MONITORING WERE PERFORMED FOR ALL SURGICAL PATIENTS.7 SINCE 2013, INTRAOPERATIVE DSA AND METHYLENE BLUE ANGIOGRAPHY HAVE BEEN USED TO FACILITATE THE RECOGNITION OF THE ANGIOARCHITECTURE AS WELL AS RESIDUAL AVSS DURING OPERATION. COMPLETE OBLITERATION WAS DEFINED AS DISAPPEARANCE OF THE INTRADURAL AVS, WHEREAS PARTIAL OBLITERATION WAS DEFINED AS ANY RESIDUAL INTRADURAL AVS RE MAINING VISIBLE AND WAS FURTHER CATEGORIZED AS SHUNT-REDUCTION OBLITERATION (THE SIZE OF THE NIDUS OR THE NUMBER OF SHUNT POINTS WAS REDUCED) AND PALLIATIVE OBLITERATION (ONLY THE ANEURYSMAL STRUCTURE OR FEEDER WAS OBLITERATED). FOLLOW-UP WAS PLANNED AT DISCHARGE, 1 MONTH AFTER DISCHARGE, 6 MONTHS AFTER DISCHARGE AND THEN AT YEARLY INTERVALS, THROUGH DIRECT CLINICAL INTERVIEWS OR TELEPHONE CONTACT. TWO HUNDRED AND FIFTY-EIGHT PATIENTS (55.7%) UNDERWENT EMBOLIZATION, 122 (26.3%) UNDERWENT MICROSURGERY, AND 83 (17.9%) UNDERWENT COMBINED TREATMENT MODALITIES. FOUR HUNDRED AND SIXTY-THREE PATIENTS RECEIVED A TOTAL OF 735 TREATMENTS (MEDIAN = 1), INCLUDING 525 EMBOLIZATION AND 210 MICROSURGERIES. RESULTS: OVERALL, COMPLETE OBLITERATION WAS ACHIEVED IN 188 PATIENTS (40.6%). TWENTY-SIX (18.1%) OF 144 PATIENTS WITH SMAVSS WERE CURED, WHICH WAS A SIGNIFICANTLY LOWER PERCENTAGE THAN THAT FOR NON-METAMERIC LESIONS. AMONG 258 PATIENTS WHO ONLY RECEIVED EMBOLIZATION, 68 (26.4%) WERE CURED. MULTIVARIATE LOGISTIC ANALYSIS INDICATED THAT FISTULA-TYPE LESIONS, NON-METAMERIC LESIONS AND DIAMETER OF MAIN DRAINAGE 51.5 MM WERE INDEPENDENT PREDICTORS FOR COMPLETE EMBOLIZATION. FOLLOWING TREATMENT, 52 PATIENTS (11.2%) EXPERIENCED PERMANENT TREATMENT-RELATED DETERIORATION, 54 (11.6%) EXPERIENCED LONG-TERM ACUTE DETERIORATION, AND 45 (9.7%) EXPERIENCED LONG-TERM GRADUAL DETERIORATION. OVERALL, IF THE ABOVE THREE KINDS OF CLINICAL DETERIORATION WERE DEFINED AS ONE END POINT, 133 PATIENTS EXPERIENCED CLINICAL DETERIORATION DURING THE TOTAL FOLLOW-UP OF 1431.03 PATIENT YEARS, YIELDING AN ANNUAL RATE OF 9.3%. COMPARED TO THE OVERALL CLINICAL DETERIORATION RATE BEFORE TREATMENT (32.5%/YEAR, 276 PATIENTS EXPERIENCED CLINICAL DETERIORATION OVER 850.1 PATIENT YEARS), THE POST-TREATMENT DETERIORATION RISK WAS SIGNIFICANTLY DECREASED. OF 341 PATIENTS WHO RECEIVED EMBOLIZATION, 19 (5.6%) EXPERIENCED PERMANENT EMBOLIZATION-RELATED DETERIORATION. STATISTICAL ANALYSIS FAILED TO FIND ANY ANGIO-ARCHITECTURAL OR THERAPEUTIC PROCEDURE RELATED RISK FACTOR. NOTABLY, FOR PATIENTS RECEIVING PALLIATIVE OBLITERATION ONLY, NO PERMANENT TREATMENT RELATED DETERIORATION WAS OBSERVED. FORTY OF 54 (74.1%) PATIENTS WHO EXPERIENCED LONG-TERM ACUTE DETERIORATION HAD RADIOLOGICAL OR SURGICAL EVIDENCE OF SPINAL HEMORRHAG E. IN 53 CASES, THE DETERIORATION OCCURRED FOLLOWING PARTIAL OBLITERATION. ONE PATIENT EXHIBITED ACUTE DETERIORATION 23.7 MONTHS AFTER COMPLETE EMBOLIZATION, BUT A SUBSEQUENT DSA INDICATED RECANALIZATION. THE TOTAL OBSERVATIONAL PERIOD FOLLOWING PARTIAL OBLITERATION WAS 993.5 PATIENT-YEARS, YIELDING AN ANNUAL LONG-TERM ACUTE DETERIORATION RATE OF 5.3%. COMPARED TO THE ACUTE DETERIORATION RATE BEFORE TREATMENT (9.3%/YEAR, 74 PATIENTS EXPERIENCED CLINICAL DETERIORATION OVER 796.1 PATIENT-YEARS), THE RISK FOLLOWING PARTIAL TREATMENT WAS SIGNIFICANTLY DECREASED. TEN OF 42 PATIENTS (23.8%) EXPERIENCED ACUTE DETERIORATION FOLLOWING PALLIATIVE OBLITERATION. FIVE OF THEM HARBOURED A RESIDUAL ANEURYSM FOLLOWING THE LATEST TREATMENT AND THE OTHER FIVE WERE PATIENTS WITH SMAVSS. THIRTY-SIX OF 45 (80.0%) PATIENTS EXPERIENCED LONG-TERM GRADUAL DETERIORATION FOLLOWING PARTIAL OBLITERATION. THE TOTAL OBSERVATIONAL PERIOD AFTER PARTIAL OBLITERATION WAS 988.28 PATIENT-YEARS, YIELDING AN ANNUAL LONG-TERM GRADUAL DETERIORATION RATE OF 3.6%. RECANALIZATION WAS OBSERVED IN 73 OF 219 PATIENTS (33.3%). MULTIVARIATE ANALYSIS INDICATED THAT PARTICULATE EMBOLIZATION, LESIONS WITH MULTIPLE DRAINAGE VEINS AND LESIONS WITH INTACT MAIN DRAINAGE FOLLOWING EMBOLIZATION TENDED TO BE ASSOCIATED WITH RECANALIZATION. FOR COMPLETELY EMBOLIZED LESIONS, RECANALIZATION WAS FOUND IN 15 CASES (50.0%). FOR PARTIALLY EMBOLIZED CASES, FOLLOW-UP DSA FOUND NEWLY FORMED ANEURYSMS IN 22 PATIENTS (11.5%), LESION PROLIFERATION IN 22 PATIENTS (11.5%), AND SPONTANEOUS OBLITERATION OF RESIDUAL LESIONS IN THREE PATIENTS (1.6%).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280503 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Unknown | Required Intervention| S |