ONYX
Report
- Report Number
- 2029214-2022-00319
- Event Type
- Death
- Date Received
- February 27, 2022
- Date of Event
- December 24, 2021
- Report Date
- February 27, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
WANG, M., LIN, F., QIU, H., CAO, Y., WANG, S., ZHAO, J. (2021). COMPARISON OF ENDOVASCULAR EMBOLIZATION PLUS SIMULTANEOUS MICROSURGICAL RESECTION VS. PRIMARY MICROSURGICAL RESECTION FOR HIGH-GRADE BRAIN ARTERIOVENOUS MALFORMATIONS. FRONTIERS IN NEUROLOGY, 12. HTTP S://DOI.ORG/10.3389/FNEUR.2021.756307. AGE OR DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
WANG, M., LIN, F., QIU, H., CAO, Y., WANG, S., ZHAO, J. (2021). COMPARISON OF ENDOVASCULAR EMBOLIZATION PLUS SIMULTANEOUS MICROSURGICAL RESECTION VS. PRIMARY MICROSURGICAL RESECTION FOR HIGH-GRADE BRAIN ARTERIOVENOUS MALFORMATIONS. FRONTIERS IN NEUROLOGY, 12. HTTP S://DOI.ORG/10.3389/FNEUR.2021.756307. AGE OR DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
WANG, M., LIN, F., QIU, H., CAO, Y., WANG, S., ZHAO, J. (2021). COMPARISON OF ENDOVASCULAR EMBOLIZATION PLUS SIMULTANEOUS MICROSURGICAL RESECTION VS. PRIMARY MICROSURGICAL RESECTION FOR HIGH-GRADE BRAIN ARTERIOVENOUS MALFORMATIONS. FRONTIERS IN NEUROLOGY, 12. HTTP S://DOI.ORG/10.3389/FNEUR.2021.756307. SUMMARY: IT REMAINS A CHALLENGE IN SURGICAL TREATMENTS OF BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS) IN SPETZLER-MARTIN GRADE (SMG) IV AND V TO ACHIEVE BOTH OPTIMAL NEUROLOGICAL OUTCOMES AND COMPLETE OBLITERATION. THE AUTHORS REPORTED A SERIES OF PATIENTS WITH AVMS IN SMG IV AND V WHO UNDERWENT A SURGICAL PARADIGM OF ENDOVASCULAR EMBOLIZATION AND SIMULTANEOUS MICROSURGICAL RESECTION BASED ON THE ONE-STAGED HYBRID OPERATION. IDENTIFIED EVENTS: 1. TWO PATIENTS DIED, ONE WAS TWO MONTHS AFTER THE OPERATION, AND THE OTHER DEATH WAS 24 MONTHS IN A COMA.
WANG, M., LIN, F., QIU, H., CAO, Y., WANG, S., ZHAO, J. (2021). COMPARISON OF ENDOVASCULAR EMBOLIZATION PLUS SIMULTANEOUS MICROSURGICAL RESECTION VS. PRIMARY MICROSURGICAL RESECTION FOR HIGH-GRADE BRAIN ARTERIOVENOUS MALFORMATIONS. FRONTIERS IN NEUROLOGY, 12. HTTP S://DOI.ORG/10.3389/FNEUR.2021.756307. SUMMARY: IT REMAINS A CHALLENGE IN SURGICAL TREATMENTS OF BRAIN ARTERIOVENOUS MALFORMATIONS (AVMS) IN SPETZLER-MARTIN GRADE (SMG) IV AND V TO ACHIEVE BOTH OPTIMAL NEUROLOGICAL OUTCOMES AND COMPLETE OBLITERATION. THE AUTHORS REPORTED A SERIES OF PATIENTS WITH AVMS IN SMG IV AND V WHO UNDERWENT A SURGICAL PARADIGM OF ENDOVASCULAR EMBOLIZATION AND SIMULTANEOUS MICROSURGICAL RESECTION BASED ON THE ONE-STAGED HYBRID OPERATION. IDENTIFIED EVENTS: 1. TWO PATIENTS DIED, ONE WAS TWO MONTHS AFTER THE OPERATION, AND THE OTHER DEATH WAS 24 MONTHS IN A COMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303309 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Male | Required Intervention| D| H |