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 Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date the article was received as the event dates were not provided in the published literature.No specific device information received.See attached 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.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

Jamieson, r.W., mcbride, o.M.B., masson, n.M.Catheter entrapment in the aortic sac during onyx embolization for type ii endoleak.Anz j surg 91.2021.E523¿e525.Doi: 10.1111/ans.16492 summary: an 83-year-old woman presented with aortic sac expansion 3 years after an endovascular aortic aneurysm repair (evar).An anaconda (terumo aortic (uk) vascutek ltd, inchinnan, renfrewshire, scotland) graft had been used, the right limb had occluded at 1 year and there was a type ii endoleak with inferior mesenteric artery (ima) retrograde flow.Trans-arterial ethylene-vinyl-alcoholcopolymer (onyx (covidien/medtronic, minneapolis, mn, usa), ev3 neurovascular) embolization of the aortic sac was planned to fill the endoleak cavity and occlude the ima origin.Reported events: onyx 34 l was injected slowly until the aneurysm sac was filled and onyx had just begun to reflux into the ima origin.Retrieval of the catheter was then attempted, but despite multiple attempts with firm traction it remained in the sac.During the surgery, the microcatheter could be palpated within the sma and the mesenteric arcade but once the ima origin had been opened, no catheter could be seen.Gentle traction then allowed the microcatheter to be removed via the femoral sheath.Mobilization of the small bowel perhaps altered tension on the microcatheter freeing it from the sac.The catheter had unravelled at the tip and elongated, presumably as a result of earlier traction.Figure 3 is an intraoperative exposure confirming successful removal of the entire catheter.The ima was oversewn and the patient made an uncomplicated recovery.

• 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: 17730016
• MDR Text Key: 323193357
• Report Number: 2029214-2023-01663
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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
• Date Manufacturer Received: 08/29/2023
• 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