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

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4) off label use: onyx was used in the peripheral vasculature.Per instruction for use: onyx indication for use is presurgical embolization of brain arteriovenous malformations bavms.The device will not be returned for analysis as it was implanted; therefore the complaint could not be confirmed, and the event cause could not be determined.The manufacturer of the catheter was not reported.

Event Description

Medtronic received a report from medwatch that during a spinal arteriogram that was performed recently, a retained partial segment of an onyx microcatheter was found in the patient extending down from the embolization site to the femoral artery.The original intended procedure was a right l2 spinal angiogram and embolization for arteriovenous malformation.No further information provided.

• Brand Name: ONYX AVM
• 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: 5252510
• MDR Text Key: 32194550
• Report Number: 2029214-2015-05167
• 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,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/02/2015

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 Expiration Date: 04/22/2016
• Device Model Number: 105-7100-060
• Device Lot Number: 9761377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/26/2015
• Date Device Manufactured: 06/14/2013
• 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 Age: 00066 YR