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

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

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

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

The lot numbers were not reported.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 reliably determined.Based on the reported information, the physician did not control the onyx reflux resulting in onyx retrograde flow over the proximal marker band of the microcatheter 1.5cm detachable tip.Per onyx instruction for use, " do not allow more than 1 cm of the onyx¿ les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx¿ les reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment." same event as reported in mdr mfr: 2029214-2015-05183.

Event Description

Medtronic received information that an apollo catheter was entrapped during onyx procedure.The patient was undergoing a presurgical embolization of brain arteriovenous malformation (bavm) in the anterior circulation.In order to form plugs around the catheter tip, the physician paused multiple times between 30 seconds to 1 minute.The duration of onyx injection was 22 minutes.Two vials of onyx were successfully delivered to the avm nidus.There was some onyx retrograde flow over the marker proximal to the detach zone of the apollo (1.5cm detachable tip).Due to this retrograde flow, the physician experienced difficulties in removing the catheter.The physician tried to applied traction to the catheter wait for 30 seconds to 1 minutes and then tried to pull some more.After 5 minutes trying to remove the catheter, the physician decided to cut the apollo microcatheter at the hub and leave it in the patient because the risk of trying to remove the catheter outweighs the benefit.Additionally, the avm surgery had been scheduled in 2 days.The patient woke up fine after the embolization.Two days post onyx embolization, the avm was resected and the catheter was removed successfully.The patient is doing well with no neurological deficit.

• 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: 5266961
• MDR Text Key: 32670937
• Report Number: 2029214-2015-05185
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-7100-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 12/04/2015
• 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): Required Intervention
• Patient Age: 00038 YR