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

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

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

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was consumed in the event. based on the reported information, there is no evidence suggested that the device was defective, but rather a procedure related event.Related mdrs for this event: 2029214-2019-00440.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the marathon catheter tip separated and was left within the anatomy.The patient underwent embolization treatment for fistula located in shunt part of occipital artery and middle meningeal artery.It was reported that during the first onyx 18 injection, the tip part of marathon broke when the marathon was removed.The broken tip part was pushed into the occipital artery with a wire, the other catheter part was removed from the patient's body.The vasculature of occipital artery was very thin, and the catheter was trapped.After the procedure, patient was administered antiplatelet drugs.There were no reports of patient injury 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: 8591190
• MDR Text Key: 144427237
• Report Number: 2029214-2019-00441
• 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: 05/08/2019

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: 105-7100-060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/08/2019
• 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): Other