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

Model Number 105-7100-080

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

Patient Problems Fistula (1862); Vascular Dissection (3160)

Event Date 04/05/2020

Event Type  Injury  

Manufacturer Narrative

A2.Reported patient age is the median age of all patients included in study group.A3.Reported patient sex (male) is representative of the majority (13/25) patient included in the study.Of the retreated patients, one was female and one was male.A separate report will be submitted for the medtronic device hyperglide balloon reported in the article.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.

Event Description

Zeineddine, h.A., lopez-rivera, v., conner, c.R., sheriff, f.G., choi, p.A., inam, m.E., cochran, j., & chen, p.R.(2020).Embolization of carotid-cavernous fistulas: a technical note on simultaneous balloon protection of the internal carotid artery.Journal of clinical neuroscience, 78, 389¿392.Https://doi.Org/10.1016/j.Jocn.2020.04.015.Medtronic review of the literature article found retrospective review of 25 consecutive cases in which patients underwent carotid-cavernous fistula (ccf) embolization between january 2013 and december 2018.12/25 patients were female and the median patient age was 40 years.In the procedures, coils and/or onyx-34 were delivered to the cavernous sinus (cs) with a 30mm x 5mm hyperglide balloon inflated within the cavernous internal carotid artery (ica) segment.There were no reported device malfunctions.No complications were seen during the procedure or in the immediate postoperative period.On follow-up, 2 cases presented a recurrence, one due to unspecified technical difficulty and the other related to an undetected vascular injury.In both cases the presence of a minimal residual fistula was noted at the time of initial treatment.Retreatment with coils and onyx-34 was performed in both cases, with required ica sacrifice in one case.After reintervention, the residual fistula was able to be successfully treated in both cases.

• Brand Name: ONYX AVM
• 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: 17739803
• MDR Text Key: 323325833
• Report Number: 2029214-2023-01697
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• 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: 09/13/2023

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: 105-7100-080
• Device Catalogue Number: 105-7100-080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/13/2023
• 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: 40 YR
• Patient Sex: Male