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 03/01/2020

Event Type  Injury  

Manufacturer Narrative

Refer to manufacturer report # 2029214-2020-00204 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that two apollo catheters were entrapped and broke inside the patient.The patient was undergoing surgery for liquid embolization in the internal carotid artery.It was noted the patient's vessel tortuosity was moderate.It was reported that after 30-40 minutes of injection, the catheter was removed from the patient.The first apollo catheter (pli10) broke in the patient's neck, but needed no intervention.The second apollo catheter (pli20) broke in the internal carotid artery (ica).Two types of snares were deployed in an attempt to remove the broken piece of catheter, however the healthcare provider (hcp) was only able to pull the piece from the ica to the eca and cca.The hcp then deployed a carotid stent to jail the catheter to one side.It was noted there was no friction/difficulty during injection, no force applied during delivery or removal, no vasospasm, and the catheters were not stuck in the guide catheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include onyx18.

Manufacturer Narrative

Model# 105-7000-060, lot# a841132, 03jun2019 exp date: 04apr2022 model# 105-7000-080, lot# a691501, 13aug2018 exp date: 08may2021.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

Medtronic received additional information.Treatment was type 4 davf.The first apollo catheter embedded in the onyx cast.The was not any future plans to retrieve the catheter tip.The patient is well so far.There was not any adverse events has been reported.There was not any note of vessel calcification.The apollo catheters flushed as indicated in the ifu.No damaged noted on any of the devices.Three different lot numbers of the onyx used in the procedure.It is unknown which onyx was used in which catheters.

• 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: 9804212
• MDR Text Key: 189333168
• Report Number: 2029214-2020-00206
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• PMA/PMN Number: P030004
• 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: 04/02/2020

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 Model Number: 105-7000-060
• Device Lot Number: A816006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention