MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 03/23/2011

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id: unk-nv-onyx; g2: citation: authors: darsaut, t.E., guzman, r., marcellus, m.L., edwards, m.S., tian, l., do, h.M., chang, s.D., levy, r.P., adler, j.R., marks, m.P., steinberg, g.K.Management of pediatric intracranial arteriovenous malformations: experience with multimodality therapy.Neurosurgery 69(3):540-556 2011.Doi:10.1227/neu.0b013e3182181c00.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

Event Description

Darsaut te, guzman r, marcellus ml, et al.Management of pediatric intracranial arteriovenous malformations: experience with multimodality therapy.Neurosurgery.2011;69(3):540-556.Doi:10.1227/neu.0b013e3182181c00.Medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to present the authors¿ 23-year experience with pediatric arteriovenous malformations (avms) using all treatment modalities to better define the natural history and results of treatment for children with low- and high-grade avms.A total of 120 patients were included (61 male, 59 female; mean age 11.7 years).Patients were treated with single-modality therapy (surgery, radiosurgery, or embolization alone), dual-modality therapy (2 of radiosurgery, embolization, or surgery) or triple-modality therapy.Various embolic materials were used, including thrombogenic coils, silk threads, polyvinyl alcohol particles, n-butyl cyanoacrylate glue, and onyx liquid embolic.There were 195 embolization procedures in 120 patients, and it was not stated how many patients received each endo vascular treatment.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted:  - eighteen children had late hemorrhages from their avm, leading to a decrease in neurological function in 12 and death in 7.Hemorrhage was defined as a clinical event with acute onset of 1 or more symptoms, including headache, loss of consciousness, or focal neurological deficit, and confirmed with computed tomography (ct) or magnetic resonance imaging (mri) demonstrating acute intracranial hemorrhage. - in total there were 16 patients with major complications and 15 patients with minor complications.A complication was counted as major (disabling) under 2 situations: either when a patient with a pretreatment baseline mrs of 0 to 1 progressed to mrs 2 or more, or when a patient with a pretreatment baseline of 2 or more had any increase in mrs.Complications were considered minor and nondisabling when they did not lead to a permanent change in mrs or only increased the mrs from 0 to 1.It was noted there were 15 endovascular complications. - three children with immediate posttreatment negative angiograms who were found to harbor avms on late follow-up.A fourth child demonstrated residual/recurrent avm 4 years after a delayed negative angiogram at almost 2 years.One of these patients had undergone 2 staged embolization procedures followed by surgical resection of their avm, with postoperative angiography (2 days after surgery) demonstrating cure.They then presented 16 years later with increasing headaches and intermittent visual symptoms; a small recurrent avm was confirmed on angiography, and they underwent uneventful repeat surgical resection.Another of these patients had immediate postoperative angiogram was that negative for avm, but suffered a minor late re-hemorrhage 9 years later.The recurrent/residual avm was subsequently resected uneventfully. - after embolization, of 47 children with residual avms, 30 went on to have surgery, leading to cure in 19 of 30 (63%).The other 17 patients were treated with radiosurgery, with cure obtained in 4 (24%).Eleven children with residual avms after embolization and surgery then underwent radiosurgery.Triple-modality therapy resulted in cure in 2 of 11.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17608574
• MDR Text Key: 321801107
• Report Number: 2029214-2023-01469
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Death
• Patient Age: 11 YR
• Patient Sex: Male