MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7000-060

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/05/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not been returned for analysis as it was implanted; therefore the complaint could not be determined.However, based on the reported information, user contributed to the catheter entrapment.In this event, it was reported that there was approximately 28mm of onyx reflux surrounding the catheter tip.Per onyx les instruction for use: "do not allow more than 1cm of onyx les 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.".

Event Description

Medtronic received information that a catheter became stuck during an onyx embolization procedure.The patient underwent onyx embolization procedure of a type iia+b dural arteriovenous fistula (davf) located in the right petrosal sinus.The vessel was moderately tortuous.During the procedure, the physician paused several times for about 2-3 minutes each.It was reported that there was 28 mm onyx reflux.A competitor's catheter became stuck and broke during removal leaving approximately 30-60cm of the catheter in the patient.Based on the procedure note, complete occlusion of the nidus of the malformation and its venous drainage was achieved by injection of a total of 0.8ml of onyx in the nidus.The patient's current status is mrs1.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5365564
• MDR Text Key: 35917584
• Report Number: 2029214-2016-00027
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2015

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 Expiration Date: 06/29/2017
• Device Model Number: 105-7000-060
• Device Lot Number: 9966572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/13/2016
• Date Device Manufactured: 09/11/2014
• 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
• Patient Age: 00031 YR
• Patient Weight: 80