MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX 18 KIT AVM US; AGENT, INJECTABLE, EMBOLIC

Model Number	105-7100-060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the tip of a deflector catheter broke off due to onyx entrapment.The patient was undergoing surgery for treatment of arteriovenous fistula (avf) with normal vessel tortuosity.It was reported that the deflector catheter was difficult to remove during onyx injection, and the tip broke off which remained in the patient.No additional surgical or medical procedures were performed to remove the catheter tip.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms as a result of this event.
Additional 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.
Event or Problem Description
Medtronic received additional information: the catheter tip embedded in the onyx cast.There was no plan to retrieve the catheter tip in the future.The remained catheter tip was pushed close to the onyx cast and finished.The anatomical location of the catheter tip is occipital artery.There was not any abnormality to the patient and not reported any adverse event.Onyx was discarded in the hospital.

• Brand Name: ONYX 18 KIT AVM US
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9917989
• Report Number: 2029214-2020-00320
• Device Sequence Number: 755102
• Product Code: MFE
• UDI-Device Identifier: 00836462005044
• UDI-Public: 00836462005044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: A899691
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/12/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other