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

Model Number 105-7000-060

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Medtronic received information regarding an apollo catheter that broke related to entrapment in onyx solution during a procedure.The patient was being treated with onyx embolization of a fistula.The external carotid artery (eca) was the access vessel and the access vessel diameter was 4mm.Vessel tortuosity was normal.It was reported that the apollo catheter was navigated up the eca to the desired embolization location.The onyx-18 solution was deployed.Some reflux occurred to about 2cm from the distal tip and did not pass the 5cm marker on the catheter.The injection of the solution was continuous over 15 seconds.Following successful embolization, the surgeon attempted to remove the catheter but the catheter seemed entrapped and instead of breaking off at the detachment zone, the catheter separated about 30cm from the distal tip.The surgeon was able to reposition the remaining catheter segment up into the eca.The broken segment of the catheter remained in the patient but there were no subsequent adverse events or symptoms reported due to the remaining catheter.

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.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

Additional information received reporting that continuous flush was maintained through the guide catheter during the procedure.The patient was treated for fistula of the superior saggital sinus fed by bilateral mma.Vessel tortuosity was moderate but within normal expectations for the anatomical location.It was confirmed that 30cm of the catheter remained in the patient and aside from the catheter remaining in the patient's body, the patient had no adverse effects or symptoms.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10098628
• MDR Text Key: 196743888
• Report Number: 2029214-2020-00502
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 105-7000-060
• Device Catalogue Number: 105-7000-060
• Device Lot Number: A986048
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/15/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other