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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that 4.77ml of onyx 18 was injected, afterwards the catheter was attempted to be retrieved but resistance was encountered.The marathon catheter broke into two parts (after 28 minutes).Break occurred at the end of the soft part about 25cm from the tip of marathon.About 25cm of the catheter tip was left in the patient's body.As the event was reportable to a regulatory authority, an investigation was required.The event was investigated to determine cause.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed.The investigation determined that this was a known event, and therefore no new formal investigation was required.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.Per the marathon ifu (instructions for use): precautions ¿ ¿if catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.Do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.¿ per the onyx les ifu: warnings ¿ ¿do not allow more than 1 cm of the onyx les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx les reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long-term effects of an entrapped catheter that is left in a patient are unknown, but potentially could include clot formation, infection, or catheter migration.¿ no corrective action is required.These types of events will be monitored as part of post market vigilance complaint trending and monitoring.Reference mdr# 2029214-2019-00536.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the onyx was injected from the feeder of the left m3 in an avm case.4.77ml of onyx 18 was injected, afterwards the catheter was attempted to be retrieved but resistance was encountered.The marathon catheter broke into two parts (after 28 minutes).Break occurred at the end of the soft part about 25cm from the tip of marathon.About 25cm of the catheter tip was left in the patient's body.The separated distal segment of the catheter is in the m3 to the ostium of the internal carotid artery (ica).The amount onyx reflux (1cm or more) was not notice and was more than desired in the peripheral blood vessel and the plug became long.Onyx embolus was used in an arteriovenous malformation (avm) case.The anatomy was severe in tortuous.The devices were each prepared per the instructions for use (ifu).The pause of onyx injection was one minute to a half at most.The patient was given antithrombotic therapy (ozagrel).The patient was reported to have been asymptomatic post the intervention.

• Brand Name: ONYX
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8685457
• MDR Text Key: 147571304
• Report Number: 2029214-2019-00537
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Lot Number: ASK-UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/10/2019
• 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): Disability
• Patient Age: 19 YR