MAUDE Adverse Event Report: COVIDIEN (IRVINE) ONYX; AGENT, INJECTABLE, EMBOLIC

Device Problem Entrapment of Device (1212)

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

Event Date 03/10/2012

Event Type  malfunction  

Manufacturer Narrative

Stemer ab, bank wo, armonda ra, et al.J neurointervent surg (2012).Doi:10.1136/neurintsurg-2011-010214 the onyx will not be returned for evaluation as it remains in the patient.The onyx model and lot numbers were not provided.The article provided limited information on this event.A cause for the reported onyx entrapment of a catheter not be conclusively determined.Mdrs related to this article: 2029214-2017-00803 2029214-2017-00804.

Event Description

Medtronic literature review found a report of a retained microcatheter after onyx embolization.The purpose of this study was to demonstrate that acute endovascular embolization of ruptured bavms is safe and feasible.The authors reviewed 21 patients who underwent onyx embolization of ruptured brain arteriovenous malformations (bavms).Of the patients, 9 were men and 12 were women; mean age was 38 years.The article states that the following asymptomatic technical complications occurred during stage i onyx embolization: - a retained microcatheter (unknown manufacturer) in the left vertebral.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6655148
• MDR Text Key: 78056494
• Report Number: 2029214-2017-00804
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2017

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: 05/24/2017
• Initial Date FDA Received: 06/20/2017
• 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