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 Aneurysm (1708); Ruptured Aneurysm (4436)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

As the model and lot number of the onyx-18 liquid embolic system was unknown, the g3 pma/501k # cannot be determined.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

Galastri, f.L., valle, l.G.M., cunha, m.J.S., schmid, b.P., garcia, r.G., lewi, d.S., affonso, b.B., <(>&<)> nasser, f.(2023).A novel balloon-assisted technique to secure visceral catheterization during a chimney endovascular repair of a ruptured abdominal aortic aneurysm in a centenarian patient.Jornal vascular brasileiro, 22, e20230018.Https://doi.Org/10.1590/1677-5449.202300182 medtronic review of the literature article found that a 100-year-old male patient with notable history of previously treated 6.5cm abdominal aortic aneurysm (aaa) presented at the emergency department in january 2022 after experiencing sudden intense abdominal pain and hemodynamic collapse.Patient had elevated heart rate, low blood pressure, and distended abdomen with a large pulsatile abdominal mass.It was noted that the aaa had previously been treated multiple times.Initially, the aaa was treated by bifurcated stent graft in 2015 followed by 2 reintervention procedures.The first reintervention had been performed in january 2020 in which the patient underwent direct percutaneous aneurysm sac puncture onyx-18 embolization.Despite efforts, the aneurysm sac continued to expand to a max diameter of 11cm so another reintervention with a non-medtronic precipitating hydrophobic injectable liquid in june 2021.When the patient presented in january 2022, angiography confirm type ia endoleak and ruptured aneurysm.Additional stenting was completed.That procedure was technically successful but the patient died on post-operative day 59 due to respiratory complications not associated with the onyx procedure in january 2020.

• 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: 18468400
• MDR Text Key: 332375416
• Report Number: 2029214-2024-00053
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/08/2024

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: Not provided
• Initial Date FDA Received: 01/08/2024
• 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: 100 YR
• Patient Sex: Male
• Patient Race: White