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 Insufficient Information (4580)

Event Date 07/13/2020

Event Type  Injury  

Event Description

Fanelli, f., cannavale, a., chisci, e., citone, m., falcone, g.M., michelagnoli, s., <(>&<)> miele, v.(2021).Direct percutaneous embolization of aneurysm sac: a safe and effective procedure to treat post-evar type ii endoleaks.La radiologia medica: official journal of the italian society of medical and interventional radiology, 126(2), 258¿263.Https://doi.Org/10.1007/s11547-020-01247-2.Medtronic review of the literature article found that 50 patients with post endovascular aortic aneurysm repair (evar) who underwent direct percutaneous sac puncture for embolization.Sac embolization was done using onyx plus concerto coils in 31 cases and onyx alone in 19 cases.There were no device malfunctions or intra-operative issues reported and it was specifically noted that there was no occurrence of non-target embolization or catheter entrapment.It was reported that technical success was achieved in all cases.It was noted that 2 patients underwent second percutaneous embolization procedures for type ii endoleak recurrence, one at 9 months and the other at 12 months.It was not indicated in the article whether these two patients were treated with coils + onyx or onyx alone.Complete resolution of endoleak was reported in both cases after the second embolization.

Manufacturer Narrative

A2.Reported patient age (55 years) is the mean age for all patients included in the study.A3.Reported patient sex (male) is the majority of patients included in the study.B3.Earliest date of publishing/online publish date is used for reported event date.A separate report will be submitted for the concerto coil possibly used int eh reported cases.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: 17762272
• MDR Text Key: 323583242
• Report Number: 2029214-2023-01739
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/17/2023

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: 08/29/2023
• Initial Date FDA Received: 09/17/2023
• 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: 55 YR
• Patient Sex: Male