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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

See attachments for literature article.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

D.C.Viana, l.H.De castro-afonso, g.S.Nakiri, l.M.Monsignore, f.P.Trivelato, b.O.Colli, d.Giansante abud; journal of neurointerventional surgery; 2017; 9:1053¿1059; extending the indications for transvenous approach embolization for superficial brain arteriovenous malformations; doi:10.1136/neurintsurg-2017-013113.Medtronic received information in a literature article of apollo catheters being trapped in onyx.The purpose of the article was to assess the safety and efficacy of the transvenous approach for superficial arteriovenous malformations (avms).  five of the patients were men (41.7%) and seven were women (58.3%).The mean age was 33.4 years. among nine patients (75%) who had a ruptured avm, eight had parenchymal hemorrhages (66.7%), one had a subarachnoid hemorrhage (8.4%), and one had a ventricular hemorrhage (8.4%).Procedure: all procedures were performed under general anesthesia.Catheterization was performed using a coaxial system through a femoral approach with a 6f sheath and full selective dsa was performed before each treatment in all patients.No heparin was infused in any patient.The right or left jugular vein was punctured, depending on the location of the avm, and a 5f sheath was inserted.Jugular access was chosen rather than femoral access in order to avoid permanent lodging of microcatheters in the heart chamber in case the microcatheter became trapped in the onyx cast and could not be safely withdrawn.A 6f guiding catheter was positioned in the cervical artery.A microcatheter (marathon or apollo; medtronic) was advanced through the 6f guiding catheter as close as possible to the nidus.This microcatheter was used for angiographic control injections during embolization, for combined double injections through the arterial and the venous access routes.A 5f vertebral or a 6f guiding catheter was advanced into the intracranial venous sinus.A detachable-tip microcatheter (apollo; medtronic) was then navigated through the draining vein of the avm and placed into the nidus.The transvenous embolization was initiated by injecting onyx-18 into the nidus through the venous access route; once an onyx reflux was obtained, penetration of the onyx all the way through to the arterial branches was achieved.After filling the nidus with onyx and anatomically obliterating the avm, the microcatheter was withdrawn.Ideally, the microcatheters were removed completely.However, in cases of entrapment, the microcatheters were cut with a blade at the level of the jugular sheath.  the rate of immediate angiographic occlusion of the avms was 91.6% (11/12).One patient in whom immediate angiographic occlusion was not achieved showed spontaneous occlusion at the 6-month follow-up.No procedural or clinical complications were observed.Arteriovenous malformation.

• 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: 17350302
• MDR Text Key: 320163637
• Report Number: 2029214-2023-01138
• 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: 07/19/2023

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: 07/13/2023
• Initial Date FDA Received: 07/19/2023
• 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: 33 YR
• Patient Sex: Female