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 Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Year is confirmed valid.G2: citation: authors: hirai, k., skripochnik, e., terrana, l.M., & loh, s.Endovascular solution to endoleak phenomenon after open repair of abdominal aortic aneurysm.Vascular and endovascular surgery 54(7):633-637 2020.Doi:10.1177/1538574420939365.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.

Event Description

Hirai k, skripochnik e, terrana lm, loh s.Endovascular solution to endoleak phenomenon after open repair of abdominal aortic aneurysm.Vascular and endovascular surgery.2020;54(7):633-637.Doi:10.1177/1538574420939365.Medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to present a technique for endovascular coiling and thrombin injection to correct a ¿type ii endoleak¿ from a back-bleeding lumbar artery after open aortoiliac and femoral aneurysm repair.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted:  - six months after treatment for endovascular aneurysm repair (evar) the patient experienced persistent leaks.The patient underwent treatment with coils and onyx.To facilitate thrombosis and to prevent flow into the created channel from catheter navigation, 10 000 u of recothrom was injected slowly into the aorta and left common iliac artery (cia) while withdrawing the catheter.Immediately after injection of the thrombin, the patient became tachyarrhythmic and profoundly hypotensive.They responded to epinephrine and vasopressor medication, and this was thought to be an allergic reaction to the thrombin or amount of thrombin.Continued flow was noted in the remnant bilateral external iliac arteries (eias) so the left eia was slowly injected with (b)(4) of recothromb despite the presumed allergy.The right common femoral artery (cfa) was also accessed so that the right eia could be injected with (b)(4) of recothrom.They had a milder reaction after these injections which was able to be mitigated quickly with preemptive medication support.The patient remained intubated for 1 day due to the adverse reaction and was ruled out from an acute coronary event.They were discharged at baseline and returned 6 weeks later for a repeat ct scan, which showed complete thrombosis of the native aorta and iliac aneurysms.

• 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: 17821146
• MDR Text Key: 324301493
• Report Number: 2029214-2023-01857
• 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: 09/26/2023

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: 09/26/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male