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 Problems Headache (1880); Obstruction/Occlusion (2422); Pseudoaneurysm (2605)

Event Date 01/01/2010

Event Type  Injury  

Event Description

Literature was reviewed regarding emergent endovascular treatment for carotid cavernous fistulas presenting as intracranial hemorrhage.In total, five patients harbored five mono-lateral lesions; two of them were obliterated by detachable balloons, two by detachable coils, and one by detachable coils and onyx glue.Only one patient was cured by another detachable balloon in the second session, and the other four patients were cured in the first session.At the two year follow up, there was no intracranial re-hemorrhage in any of the patients; there was no recurrence of symptoms; and delayed occlusion of the parent artery was noted in one case.Two patients who were treated with detachable balloons experienced transient headaches after the procedure, which were spontaneously alleviated by medication.One patient who was treated with detachable balloons was found to have delayed spontaneous occlusion of the lesional ica.A pseudoaneurysm was noted by head ct angiography (cta) in one patient.

Manufacturer Narrative

Concomitant products: product id unk-nv-axium (unknown); product type: ; implant date n/a; product id unk-nv-echelon (unknown); product type: ; implant date n/a; authors: chen a-l, chen y, yang d-h, wan y-h, wu y, dai c-g and zhu q.Case report: emergent endovascular treatment for carotid cavernous fistulas presenting as intracranial hemorrhage.Frontiers in neurology 14:1133259 2023.10.3389/fneur.2023.1133259 b3: 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.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.

• 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: 18188359
• MDR Text Key: 328737248
• Report Number: 2029214-2023-02267
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

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: 11/10/2023
• Initial Date FDA Received: 11/21/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female