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

Model Number	105-7100-060
Medical Device Problem Codes	Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Infarction, Cerebral (1771)
Date of Event	11/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Visual disturbance is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).However, the exact cause for the adverse event and malfunction remain unknown.Linked mdrs: 2029214-2019-01131.If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.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 AVM
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9498878
• Report Number: 2029214-2019-01266
• Device Sequence Number: 11508517
• Product Code: MFE
• UDI-Device Identifier: 00836462005044
• UDI-Public: 00836462005044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 105-7100-060
• Device Lot Number: A811695
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1