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

Model Number 105-7000-060

Device Problems Break (1069); Sticking (1597)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2014

Event Type  Injury  

Manufacturer Narrative

The device will not been returned for analysis as it was implanted; therefore the complaint could not be determined.Additional information regarding how the micro-catheter ruptured when it was removed has been requested.Per onyx instruction for use: difficult catheter removal or catheter entrapment may be caused by one or more of the following factors: long catheterization time.Angio-architecture: very distal arteriovenous malformation fed by afferent, lengthened, small, or tortuous pedicles.Vasospasm.Reflux.Injection time.

Event Description

Medtronic received information from corelab that during an onyx embolization procedure a catheter was broken and stuck and the patient's left anterior carotid artery was occluded.The patient was treated for a ruptured left parieto-occipital arteriovenous malformation (avm) fed by a dilated posterior sylvian branch and drained by two superficial cortical veins, rejoining the superior sagittal sinus.Using micro-catheterization with a competitor's micro-catheter, one vial of onyx was injected into a compartment of the malformation.Then, using the same entry point, another catheterization procedure with a competitor's micro-catheter was performed to inject another vial of onyx into the other lower compartment.The angiogram showed that the arteriovenous malformation had been eradicated.The micro-catheter ruptured when it was removed.All these complications were reported to be related to catheter, onyx device and onyx embolization procedure.The decision was made to leave the micro-catheter in place and to prescribe 250 mg of acetylsalicylic acid and 1 tablet of clopidogrel for 3 months.There was no change in the patient's neurological condition upon waking.

Manufacturer Narrative

Type of reportable event: serious injury.The user did not follow the instruction for use.Per onyx les instructions for use: "do not allow more than 1cm of onyx les to 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 effect of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection or catheter migration.".

Event Description

The catheter became entrapped with approximately 3cm of onyx reflux and approximately 20cm of the catheter is remaining in the patient.There was no vasospasm.The patient's current status is good.

• 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: 5312076
• MDR Text Key: 34738590
• Report Number: 2029214-2015-05212
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2016
• Device Model Number: 105-7000-060
• Device Lot Number: 9836359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Date Device Manufactured: 12/02/2013
• 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 Outcome(s): Other
• Patient Age: 00034 YR
• Patient Weight: 58