MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2009

Event Type  malfunction  

Manufacturer Narrative

Pierot, l.(2005).Endovascular treatment of brain arteriovenous malformations using onyx: preliminary results of a prospective mult icenter study.Interventional neuroradiology, 11(1_suppl), 159-164.Doi:10.1177/15910199050110s119.The onyx will not be returned for evaluation as it remains in the patient.The onyx model and lot numbers were not provided.The article provided limited information on these events.A cause for the reported onyx migration resulting in embolization of an unintended location could not be conclusively determined.Mdrs related to this article: 2029214-2017-00805, 2029214-2017-00806, 2029214-2017-00807, 2029214-2017-00808.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

Medtronic literature review found reports of technical issues during onyx embolization.The purpose of this article was to evaluate the safety and efficacy of onyx in the embolization of brain arteriovenous malformations (avms).The authors reviewed 48 patients (25 female, 23 male, mean age 41 years).The article states that the following technical problems occurred during onyx embolization: rupture of the microcatheter was reported in one case.In two cases, withdrawal of the microcatheter was impossible.The article states that procedures were performed using a dmso-compatible microcatheter.

Event Description

Additional information received : pierot l, januel a-c, herbreteau d, et al.Malformations using onyx: results of a prospective, multicenter study.Journal of neuroradiology.2009;36(3):147-152.Doi:10.1016/j.Neurad.2008.11.005.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to evaluate the safety and efficacy of onyx for embolization of brain arteriovenous malformations (bavm).A prospective, multicenter study was conducted in france to evaluate embolization of bavm with onyx.From may 2003 to march 2005, 50 patients (26 females, 24 males; mean age: 34.8 years, range: 16¿64 years) were included.Clinical presentation was hemorrhage in 22 patients (44.0%), seizures in 16 patients (32.0%), headaches in six patients (12.0%) and progressive neurological deficit in two cases (4.0%).Four patients were asymptomatic (8.0%).Patients harbouring bavm treatable by endovascular approach were included if the treatment was partially or completely performed using onyx.One hundred and forty-nine sessions of embolization were performed.One hundred and sixteen sessions (77.9%) were performed with onyx, 20 sessions (13.4%) with glue and 13 sessions (8.7%) with onyx and glue.Procedures were performed with patients under general anesthesia.Steps of the procedures were superselective catheterization of the nidus using a dimethyl sulfoxide (dmso) compatible microcatheter and microguidewire (ultraflow and mirage, micro therapeutics, inc.).The microcatheter tip was placed as close as possible to the avm nidus.Before onyx injection, the microcatheter was flushed with normal saline and the catheter dead space was filled with 0.25 ml dmso.Then 0.25 ml onyx was slowly injected (60 s) to fill the microcatheter and replace the dmso in the catheter dead space.Slow injection of the onyx was then continued under fluoroscopy.In case of reflux, the injection was stopped for 2 min.In case of venous passage, injection was briefly stopped.Various techniques were used to withdraw the microcatheter (slow continuous traction, fast traction).The following technical issues were noted: -withdrawal of the micro catheter was impossible in four cases (by fast traction in three cases and slow traction in one case).-rupture of the microcatheter was reported in two cases.When the microcatheter was left in place (withdrawal impossible or rupture), antiplatelet medication was given for several weeks to avoid thromboembolic complications.All the technical problems had no clinical impact.

Manufacturer Narrative

Pierot l, januel a-c, herbreteau d, et al.Malformations using onyx: results of a prospective, multicenter study.Journal of neuroradiology.2009;36(3):147-152.Doi:10.1016/j.Neurad.2008.11.005 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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: 6655464
• MDR Text Key: 78132355
• Report Number: 2029214-2017-00806
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030004
• 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,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/26/2023
• 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 Age: 35 YR
• Patient Sex: Female