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

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problem Rupture (2208)

Event Date 02/16/2020

Event Type  Injury  

Manufacturer Narrative

The onyx will not be returned for evaluation as it was consumed in the event.  based on the reported information, there did not appear to have been any defect of the device during use.This is procedure related event.Related mdrs for this event: 2029214-2020-00288.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that apollo catheter separated as it was difficult to remove from the onyx cast.This patient has had multiple treatments in radiology to address his large cerebral arteriovenous malformation (avm).First presentation was when it ruptured.This case was to embolize another feeder that had not previously been treated.The inr was unwilling to pull the microcatheter out while he had no visibility but the 7-minute delay in rebooting the machines meant the catheter became difficult to remove from the onyx cast.Aspiration on the syringe and traction were unsuccessful.Strong traction resulted in the catheter broke/ separated about 10cm from the tip, and resulted in a rupture of the feeding vessel, which was treated effectively with coils.The device and the accessory devices were prepared as indicated in the instructions for use (ifu).There was no resistance when the onyx was used.0.1 ml per minute was the injection rate.The vessel anatomy was moderate in tortuosity.The patient was 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 ; 9496801345
• MDR Report Key: 9872465
• MDR Text Key: 195544418
• Report Number: 2029214-2020-00289
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/24/2020

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?: 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: 03/04/2020
• Initial Date FDA Received: 03/24/2020
• 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
• Patient Age: 37 YR