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

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2024

Event Type  malfunction  

Manufacturer Narrative

Associated with uf/importer rpt num: 1001510000-2024-8003 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that an echelon catheter had fractured.The patient was undergoing treatment for transarterial embolization of the occipital artery.Distal access into the right occipital artery was obtained with an echelon microcatheter.The microcatheter run demonstrated good po sitioning of the microcatheter.The catheter was then flushed with dmso and onyx 18 was then slowly injected under constant fluoroscopic guidance utilizing a blank road map.Three vials of onyx 18 were used with care to avoid reflux as they embolized back to the i ntermediate catheter.Periodic runs were performed confirming progressive embolization with significant reduction in supply to the fistula.At this point the elected to conclude the procedure and performed a staged approach to treatment of the complex fistula with multiple feeders.We attempted to withdraw the microcatheter however there was significant resistance and ultimately the catheter fractured.Remnant catheter was observed within the intermediate catheter down into the common carotid artery.They attempted to use a guidewire to push the remnant catheter up into the occipital artery however, the wire was sliding past the catheter.The pxs slim microcatheter was then introduced into the sofia and occipital artery.And the wire used to push out the echelon 10 microcatheter which was noted to be coiled in the occipital artery.Final runs were performed demonstrating no evidence of any thromboembolic complications and decreased filling of the fistula.There were no patient symptoms or complications associated with this event.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18893222
• MDR Text Key: 337654313
• Report Number: 2029214-2024-00418
• 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: Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• 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 Age: 65 YR
• Patient Weight: 102 KG
• Patient Race: White