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 Hemorrhage/Bleeding (1888); Necrosis (1971); Respiratory Failure (2484)

Event Date 01/28/2021

Event Type  Death  

Event Description

Sullivan iw, digrazia g, chen x, amin p.Jejunal necrosis after embolization with ethylene vinyl alcohol copolymer.Journal of vascular and interventional radiology.January 2021.Doi:10.1016/j.Jvir.2021.01.278.Medtronic literature review found a report of patient complications in association with onyx liquid embolic.The article does not state any technical issues during use of the onyx.A patient was hospitalized with a left lung allograft for idiopathic pulmonary fibrosis presented with pneumonia, sepsis, and a hemoglobin level of 5.8 g/dl.The early hospital course included episodic maroon-colored stools without source identification on serial endoscopy.On the seventh hospital day, a tagged red blood cell scan localized the hemorrhage to the proximal jejunum, which was subsequently identified on angiography and embolized with microcoils.Three days later, a second episode of jejunal bleeding was also successfully treated with microcoil embolization.Two weeks later, a third episode was successfully treated with onyx.On the same week, a fourth episode of bleeding prompted resection.Examination of a gross specimen and corresponding radiography demonstrated mucosal necrosis in the region of onyx embolization.Histopathology specimen revealed the interface between necrotic and viable mucosa.Submucosal arterioles containing onyx were identified.A higher power light micrograph demonstrated a pigmented onyx copolymer wi thin the arteriole.However, resection was complicated by recurrent hemorrhage, requiring laparotomy and ligation the following day.The patient ultimately expired from respiratory failure 2 weeks after the surgery.

Manufacturer Narrative

G2: citation: authors: sullivan, i.W., digrazia, g., chen, x., <(>&<)> amin, p.Jejunal necrosis after embolization with ethylene vinyl alcohol copolymer.Journal of vascular and interventional radiology january 2021.Doi:10.1016/j.Jvir.2021.01.278 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: 17719746
• MDR Text Key: 323074117
• Report Number: 2029214-2023-01638
• 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: 09/11/2023

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: 08/15/2023
• Initial Date FDA Received: 09/11/2023
• 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): Death; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male