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

Model Number UNK-NV-ONYX

Device Problem Entrapment of Device (1212)

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

Event Date 11/01/2003

Event Type  Injury  

Manufacturer Narrative

Citation: endovascular treatment of intracranial arterio-venous malformations with onyx embolization: preliminary experience.Florio f1, lauriola w, nardella m et.Al the device will not be returned for evaluation as it was consumed in the event; therefore, no definitive conclusion can be drawn regarding the clinical observation.Additional information has been requested from the author of this article regarding this case.Should it become available a supplemental report will be submitted.Per onyx instruction for use: do not allow more than 1 cm of onyx¿ les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux, or prolonged injection time may result in difficult catheter removal and catheter 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 is unknown, but could potentially include clot formation, infection or catheter migration.Mdrs related to this event: 2029214-2017-00350 2029214-2017-00351 2029214-2017-00352 2029214-2017-00353 2029214-2017-00354 2029214-2017-00355.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information during literature review that during embolization procedure with onyx, three catheters glued at the injection site.In all three cases the treatment was discontinuation due to continuous and massive reflux of onyx into the afferent artery peduncle.Ten patients were treated (7 men, 3 women; mean age: 29 years, range: 12-48 years) for a total of 37 embolizations, 22 with onyx and 15 with acrylic resin.

• 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 ; 9498373700
• MDR Report Key: 6455708
• MDR Text Key: 71575617
• Report Number: 2029214-2017-00353
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/13/2017

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
• Device Model Number: UNK-NV-ONYX
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/03/2017
• 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