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 Aneurysm (1708)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: yoshida, k., sato, s., inoue, t., ryu, b., shima, s., mochizuki, t., kuwamoto, k., okada, y., niimi, y.Transvenous embolization for craniocervical junction epidural arteriovenous fistula with a pial feeder aneurysm.Interventional neuroradiology: journal of peritherapeutic n 26(2):170-177 2020.Doi:10.1177/1591019919874571.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.

Event Description

Yoshida k, sato s, inoue t, et al.Transvenous embolization for craniocervical junction epidural arteriovenous fistula with a pial f eeder aneurysm.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2020;26(2):170-177.Doi:10.1177/1591019919874571.Medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to present a case of craniocervical junction (ccj) epidural arteriovenous fistula (avf) with a pial feeder aneurysm that experienced recanalization secondary to recruitment of new shunt flow.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted:  - transarterial coil embolization of the ruptured aneurysm and partial onyx embolization of the shunt led to thrombosis of the aneurysm.The patient was discharged home without neurological deficit.However, three years later angiography showed an increased shunt flow and recurrence of the aneurysm.Transvenous embolization of the shunt using coils and onyx yielded complete obliteration of the shunt, thus leading to occlusion of the aneurysm.

Manufacturer Narrative

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.

Event Description

Additional information received reported that of the adverse events that were mentioned within the article, none of them relate directly to medtronic devices/products.

• 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: 17591730
• MDR Text Key: 321627835
• Report Number: 2029214-2023-01443
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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: 07/27/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 10/02/2023
• 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: 65 YR
• Patient Sex: Male