ONYX
Report
- Report Number
- 2029214-2022-00242
- Event Type
- Death
- Date Received
- February 20, 2022
- Date of Event
- January 1, 2010
- Report Date
- February 20, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BAHARVAHDAT H, BLANC R, FAHED R, POOYAN A, MOWLA A, ESCALARD S, DELVOYE F, DESILLES JF, REDJEM H, CICCIO G, SMAJDA S, HAMDANI M, MAZIGHI M, PIOTIN M. ENDOVASCULAR TREATMENT AS THE MAIN APPROACH FOR SPETZLER¿MARTIN GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS. JOURNAL OF NEUROINTERVENTION SURGERY. 2021;13:241¿246. DOI: 10.1136/NEURINTSURG-2020-016450. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
BAHARVAHDAT H, BLANC R, FAHED R, POOYAN A, MOWLA A, ESCALARD S, DELVOYE F, DESILLES JF, REDJEM H, CICCIO G, SMAJDA S, HAMDANI M, MAZIGHI M, PIOTIN M. ENDOVASCULAR TREATMENT AS THE MAIN APPROACH FOR SPETZLER¿MARTIN GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS. JOURNAL OF NEUROINTERVENTION SURGERY. 2021;13:241¿246. DOI: 10.1136/NEURINTSURG-2020-016450. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
BAHARVAHDAT H, BLANC R, FAHED R, POOYAN A, MOWLA A, ESCALARD S, DELVOYE F, DESILLES JF, REDJEM H, CICCIO G, SMAJDA S, HAMDANI M, MAZIGHI M, PIOTIN M. ENDOVASCULAR TREATMENT AS THE MAIN APPROACH FOR SPETZLER¿MARTIN GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS. JOURNAL OF NEUROINTERVENTION SURGERY. 2021;13:241¿246. DOI: 10.1136/NEURINTSURG-2020-016450. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE CLINICAL/IMAGING OUTCOMES AND THE PROCEDURAL SAFETY OF ENDOVASCULAR APPROACH AS THE MAIN TREATMENT FOR THE CURE OF SPETZLER¿MARTIN (SM) GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). THE AUTHORS REVIEWED 65 CASES OF PATIENTS TREATED FOR ARTERIOVENOUS MALFORMATIONS USING ONYX. OF THE 65 PATIENTS, THE AVERAGE AGE WAS (B)(6) YEARS, 29 WERE FEMALE AND 36 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. SIGNIFICANT HEMORRHAGIC COMPLICATIONS OCCURRED IN 13 PATIENTS (20%), INCLUDING ONE SUBARACHNOID HEMORRHAGE (SAH), FIVE INTRAVENTRICULAR HEMORRHAGE (IVH) WITH OR WITHOUT SAH, AND SEVEN INTRAPARENCHYMAL HEMORRHAGE (IPH). ELEVEN PATIENTS REQUIRED SURGERY, INCLUDING SIX EXTERNAL VENTRICULAR DRAINAGE AND FIVE CRANIOTOMY AND IPH REMOVAL. FIVE PATIENTS (7.7%) EXPERIENCED ISCHEMIC COMPLICATIONS, ALL OF THEM TREATED MEDICALLY. THERE WAS NO SIGNIFICANT DIFFERENCE FOR THE OCCURRENCE OF HEMORRHAGIC COMPLICATIONS BETWEEN THE RUPTURED AND UNRUPTURED GROUPS. ISCHEMIC COMPLICATIONS WERE SIGNIFICANTLY MORE COMMON IN THE UNRUPTURED GROUP COMPARED WITH THE RUPTURED GROUP. IN UNIVARIATE ANALYSIS, AGE >40, DIFFUSE NIDUS, PRESENCE OF NIDAL ANEURYSMS, SINGLE VENOUS DRAINAGE, AND PRESENCE OF DRAINING VEIN ECTASIA WERE PREDICTORS OF POST-OPERATIVE HEMORRHAGE. PERMANENT NEUROLOGICAL DEFICITS WERE DETECTED IN FOUR PATIENTS (6.2%). A MOTOR DEFICIT WAS THE MOST COMMON DEFICIT. POST-EVT, GOOD MRS WAS ACHIEVED IN 55 PATIENTS (84.6%). TEN (15.4%) PATIENTS HAD A POOR MRS AT LAST VISIT. TWO (3.1%) PATIENTS DIED DURING HOSPITALIZATION DUE TO HEMORRHAGIC COMPLICATIONS FOLLOWING EMBOLIZATION. IN TOTAL, EIGHT (12.3%) PATIENTS EXPERIENCED MRS WORSENING. THE RATE OF PERMANENT DEFICIT AND POOR OUTCOME WAS NOT DIFFERENT BETWEEN THE RUPTURED AND UNRUPTURED GROUPS. BOTH IN UNIVARIATE AND MULTIVARIATE ANALYSIS, PRE-OP CLINICAL CONDITION (POOR PRE-OP MRS) AND HEMORRHAGIC COMPLICATIONS WERE SIGNIFICANT INDEPENDENT PREDICTORS OF POOR OUTCOME.
BAHARVAHDAT H, BLANC R, FAHED R, POOYAN A, MOWLA A, ESCALARD S, DELVOYE F, DESILLES JF, REDJEM H, CICCIO G, SMAJDA S, HAMDANI M, MAZIGHI M, PIOTIN M. ENDOVASCULAR TREATMENT AS THE MAIN APPROACH FOR SPETZLER¿MARTIN GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS. JOURNAL OF NEUROINTERVENTION SURGERY. 2021;13:241¿246. DOI: 10.1136/NEURINTSURG-2020-016450. MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF PATIENT COMPLICATIONS IN ASSOCIATION WITH ONYX. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE CLINICAL/IMAGING OUTCOMES AND THE PROCEDURAL SAFETY OF ENDOVASCULAR APPROACH AS THE MAIN TREATMENT FOR THE CURE OF SPETZLER¿MARTIN (SM) GRADE III BRAIN ARTERIOVENOUS MALFORMATIONS (BAVMS). THE AUTHORS REVIEWED 65 CASES OF PATIENTS TREATED FOR ARTERIOVENOUS MALFORMATIONS USING ONYX. OF THE 65 PATIENTS, THE AVERAGE AGE WAS (B)(6) YEARS, 29 WERE FEMALE AND 36 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ONYX. SIGNIFICANT HEMORRHAGIC COMPLICATIONS OCCURRED IN 13 PATIENTS (20%), INCLUDING ONE SUBARACHNOID HEMORRHAGE (SAH), FIVE INTRAVENTRICULAR HEMORRHAGE (IVH) WITH OR WITHOUT SAH, AND SEVEN INTRAPARENCHYMAL HEMORRHAGE (IPH). ELEVEN PATIENTS REQUIRED SURGERY, INCLUDING SIX EXTERNAL VENTRICULAR DRAINAGE AND FIVE CRANIOTOMY AND IPH REMOVAL. FIVE PATIENTS (7.7%) EXPERIENCED ISCHEMIC COMPLICATIONS, ALL OF THEM TREATED MEDICALLY. THERE WAS NO SIGNIFICANT DIFFERENCE FOR THE OCCURRENCE OF HEMORRHAGIC COMPLICATIONS BETWEEN THE RUPTURED AND UNRUPTURED GROUPS. ISCHEMIC COMPLICATIONS WERE SIGNIFICANTLY MORE COMMON IN THE UNRUPTURED GROUP COMPARED WITH THE RUPTURED GROUP. IN UNIVARIATE ANALYSIS, AGE >40, DIFFUSE NIDUS, PRESENCE OF NIDAL ANEURYSMS, SINGLE VENOUS DRAINAGE, AND PRESENCE OF DRAINING VEIN ECTASIA WERE PREDICTORS OF POST-OPERATIVE HEMORRHAGE. PERMANENT NEUROLOGICAL DEFICITS WERE DETECTED IN FOUR PATIENTS (6.2%). A MOTOR DEFICIT WAS THE MOST COMMON DEFICIT. POST-EVT, GOOD MRS WAS ACHIEVED IN 55 PATIENTS (84.6%). TEN (15.4%) PATIENTS HAD A POOR MRS AT LAST VISIT. TWO (3.1%) PATIENTS DIED DURING HOSPITALIZATION DUE TO HEMORRHAGIC COMPLICATIONS FOLLOWING EMBOLIZATION. IN TOTAL, EIGHT (12.3%) PATIENTS EXPERIENCED MRS WORSENING. THE RATE OF PERMANENT DEFICIT AND POOR OUTCOME WAS NOT DIFFERENT BETWEEN THE RUPTURED AND UNRUPTURED GROUPS. BOTH IN UNIVARIATE AND MULTIVARIATE ANALYSIS, PRE-OP CLINICAL CONDITION (POOR PRE-OP MRS) AND HEMORRHAGIC COMPLICATIONS WERE SIGNIFICANT INDEPENDENT PREDICTORS OF POOR OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2099388 | ONYX | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-ONYX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Death |