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 02/27/2006

Event Type  Injury  

Manufacturer Narrative

Citation: brain avm embolization with onyx.W.J.Van rooij, m.Sluzewski, g.N.Beute et.Al.The devices were not returned for evaluation; therefore the complaint could not be confirmed and the event causes could not be determined.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 article: 2029214-2017-00359 2029214-2017-00360 2029214-2017-00361 2029214-2017-00362 2029214-2017-00363 2029214-2017-00364 2029214-2017-00365 2029214-2017-00366 2029214-2017-00367 2029214-2017-00368.

Event Description

Medtronic received information through literature review that during embolization procedure with onyx, the catheter glued in the anterior venous malformation (avm) in 2 patients.Microcatheter was cut off in the groin without clinical sequelae.Between may 2000 and december 2005, 44 patient with brain avms were embolized with onyx.There were 18 women and 26 men with a mean age of 42.4 years (median 44, range 14-71 years).

• 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: 6458043
• MDR Text Key: 71683649
• Report Number: 2029214-2017-00368
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/04/2017
• 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
• Patient Outcome(s): Other