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

Device Problem Entrapment of Device (1212)

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

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

The onyx has not been returned for evaluation; product analysis could not be performed.The device was not returned; the reported event could not be confirmed and the event cause could not be conclusively determined from the provided information.Mdrs related to this event: 2029214-2019-00759 2029214-2019-00760.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report or apollo rupture with onyx.The patient was undergoing embolization of an arteriovenous malformation (avm) in the posterior fossa.The devices were prepared as indicated in the ifu.A continuous flush was maintained during the procedure.It was reported that during the procedure, the apollo was attempted to be withdrawn.Rupture of the catheter was observed with reflux of onyx.Approximately 15cm of onyx remained in the artery of the patient.There were no reports of clinical consequences in association with this event.

• 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: 8805898
• MDR Text Key: 151737960
• Report Number: 2029214-2019-00760
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/19/2019
• 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