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

Model Number 105-7000-060

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an apollo catheter that was noted to be leaking onyx during the procedure and broke during retrieval.The patient was undergoing an onyx embolization procedure to treat an occipital arteriovenous malformation (avm).Vessel tortuosity was minimal.The procedure was performed via femoral access and the access vessel diameter was 8mm.It was reported that all devices were prepared and the catheter flushed as indicated in the instructions for use (ifu).During onyx injection, it was observed that resistance was relatively significant.After the injection of onyx, it was found that the distal end of the apollo catheter was embedded in the onyx but the onyx did not reflux back to the detachment point.It was then difficult to retrieve the catheter.Under fluoroscopy, the middle section of the apollo was observed to be leaking onyx at about the v4 segment and it was suspected the apollo catheter was ruptured.The surgeon continued pulling back the apollo slowly for withdrawn and it was able to be withdrawn.However, it was observed that the catheter soft distal segment had broken rather than detaching at the detachment point.No vasospasm was observed.The withdrawn portion of the catheter was measured to be about 147cm.A non-medtronic stent retriever was used to successfully remove the leaked onyx from the unintended vessel location.Fluoroscopy showed about 10cm of the apollo catheter remained in the patient's vessel.After removal the of the leaked onyx, the patient had no further adverse symptoms.

Event Description

The patient's weight was reported.

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.

• Brand Name: ONYX AVM
• 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: 12689522
• MDR Text Key: 278140216
• Report Number: 2029214-2021-01331
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

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: 07/08/2023
• Device Model Number: 105-7000-060
• Device Catalogue Number: 105-7000-060
• Device Lot Number: B087291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 11/23/2021
• Date Device Manufactured: 09/16/2020
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 65 KG