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

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/06/2011

Event Type  Injury  

Event Description

Citation: medtronic received information through literature review of "onyx embolization of extradural spinal arteriovenous malformation with intradural venous drainage".There was one case where a section of the catheter was left within the patient as there was an abundant amount of reflux into the lumbar 3 artery.The arteriovenous malformation (avm) was located in the left l3 lumbar.Angiography did not show persistent filling of avm.The patient was reported to have rapidly regained neurological function post the treatment.After brief inpatient rehabilitation, the patient was dismissed.3 month follow up showed persistent obliteration of the avm.At 9 mounts the patient had no focal deficit.Mdr # 2029214-2015-00676, mdr # 2029214-2015-00684.

Manufacturer Narrative

(b)(6).This report was generated to capture the device separation, which remains within the patient.The device was not returned for analysis as it was consumed in the event.The lot number was not reported.Based on the reported information, there is no evidence suggesting that the onyx was defective, but rather a procedure related event.Per the onyx instruction for use (ifu): do not allow more than 1 cm of onyx to reflux back over catheter tip.Excessive onyx reflux may result in difficult catheter removal and potential entrapment.(b)(4).

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9496801224
• MDR Report Key: 4845138
• MDR Text Key: 5908452
• Report Number: 2029214-2015-00678
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 62 YR