MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number	105-7100-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See related regulatory report 2029214-2019-00093.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of bacterial infection after onyx embolization.It was reported that the patient underwent endograph leak repair using onyx 18 and onyx 34.Approximately 70 days post-embolization, the patient presented at the hospital with a severe aortic infection caused by bacteria.The name of the bacteria was not provided, but it was reportedly a skin-transmissible microorganism.The patient underwent surgery to remove the onyx; the customer is reportedly in possession of the onyx material.The patient is reportedly doing well.

• Brand Name: ONYX AVM
• Common Device Name: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8307595
• Report Number: 2029214-2019-00094
• Device Sequence Number: 62744
• Product Code: MFE
• UDI-Device Identifier: 00847536006188
• UDI-Public: 00847536006188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: 105-7100-080
• Device Catalogue Number: 105-7100-080
• Device Lot Number: A642569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• 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
• Patient Age: 81 YR