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

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

The onyx will not be returned for evaluation as it was consumed in the event; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The event happened in post onyx embolization; therefore, the cause of the event cannot be conclusively determined from the provided information.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.¿ related mdrs for this event: 2029214-2019-01117, 2029214-2019-01118.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that after onyx embolization, the catheter was unable to be removed, and when it was further pulled, the catheter was broken where was about 30 cm from the tip part.The broken piece left in aorta from middle cerebral artery (mca).The patient underwent embolization treatment for an arteriovenous malformation.There were no reports of patient injury in association with this event.The device prepared according to the instructions per the ifu.It was further reported that the catheter which remained in the patient¿s body could be removed during the explanation of arteriovenous malformation (avm).Avm was explanted by craniotomy.

• 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 ; 9496801345
• MDR Report Key: 9305241
• MDR Text Key: 170459823
• Report Number: 2029214-2019-01118
• 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: 11/11/2019

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: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: No
• 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