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

Model Number 105-7000-060

Device Problem Entrapment of Device (1212)

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

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

Embolic material was noted within the microcatheter.However, the remaining embolic material was not returned for analysis as it was consumed in the event.Based on the reported information and device analysis, the report of catheter separation was confirmed.Per the onyx les ifu: 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.Mdr related to this event: 2029214-2017-00357 2029214-2017-00358.

Event Description

Medtronic received report that during the liquid embolization of dural arteriovenous fistula (avf), the catheter was reported to have separated at the distal section, as it was entrapped by the embolic material within the external carotid branch.The distal section of the catheter was not removed and 2 coils were used to push the separated segment into the distal vessel.The patient was asymptomatic and no additional medical intervention was required.The anatomy was reported to have been moderate in tortuosity.Access vessel was the middle meningeal.3 different catheters were used, it is unknown which of these 3 lots (a382700 / a356631 / a356629) was one that separated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 ; 9492753836
• MDR Report Key: 6456812
• MDR Text Key: 71619610
• Report Number: 2029214-2017-00358
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: 105-7000-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: 03/08/2017
• Supplement Dates FDA Received: 10/02/2017
• 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): Required Intervention
• Patient Age: 57 YR