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 Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Refer to manufacturer report 2029214-2020-00848 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the apollo catheter became entrapped in onyx during removal and broke off in the patient.It was noted the patient's vessel tortuosity was moderate.It was reported that the apollo catheter was used during the delivery of onyx.On the second injection, there was friction/difficulty and 4cm of onyx reflux, and the catheter was removed.During the removal, force had to be applied and the distal portion of the catheter was entrapped and broke off.The broken segment was retrieved by a solitaire device, and the remaining distal portion was stented in place with an atlas stent.There was no vasospasm, and the catheter was not stuck inside the guide catheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a cook 6f shuttle, phenom plus 120cm, mirage.008, atlas stent.

Event Description

Additional information received reporting that the procedure was to treat arteriovenous malformation near the posterior interior carotid artery.The dead space of the catheter was filled with dmso.The waiting time was approximately 1 minute between injections.The injection was very slow and was stopped once reflux was observed.The patient was reportedly recovering well post-op.

Manufacturer Narrative

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.

• Brand Name: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10457942
• MDR Text Key: 204518007
• Report Number: 2029214-2020-00849
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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
• Device Catalogue Number: 105-7100-060
• Device Lot Number: B024185
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR