MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-080

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

Patient Problem Infarction, Cerebral (1771)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

The medtronic liquid embolic involved in the event will not be returned as it remains in the patient; therefore, the event cause could not be determined.The microcatheter was requested for return.Correspondence has been sent for return of the device and additional information.Once the device has been received and/or information is received and the investigation has been completed, then a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient developed a cerebral infarction a few days after medtronic liquid embolic embolization treatment.Prior to the event, the medtronic liquid embolic was injected from the distal end of the left pica.It was reported that there was difficulty removing the microcatheter because the tip was stuck.Once the catheter was removed, there was separation and movement of an medtronic liquid embolic lump.The patient was undergoing embolization treatment of an arteriovenous malformation (avm).The medtronic liquid embolic embolization was performed in the left pica, but the postoperative mri confirmed cerebral infarction in the pc area.

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

Medtronic received additional information: this event occurred during the treatment of an arteriovenous malformation (avm), the feeder was severely tortuous.Onyx was injected at 0.25 / 90 seconds.It was reported that there was onyx reflux to the catheter, there was some resistance, but it was not hard to remove the catheter.Removal of nidus was performed.There was no vasospasm.Some left visual field disorder remained.The condition was not very good since bleeding occurred originally.The patient was planned to be transferred to a rehabilitation facility later.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9319202
• MDR Text Key: 177401646
• Report Number: 2029214-2019-01131
• 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: 12/19/2019

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: 05/23/2020
• Device Model Number: 105-7100-080
• Device Lot Number: A515755
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1