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

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Ambulation Difficulties (2544)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Sahajwalla d, vorona g, tye g, et al.Aggressive vertebral hemangioma masquerading as neurological disease in a pediatric patient.Radiology case reports.2021;16(5):1107-1112.Doi:10.1016/j.Radcr.2021.02.023.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to present a case of a 13-yearold male who presented with a three month history of lower extremity weakness that was found to have an infiltrative mass at t10 with associated cord compression from epidural extension of the lesion.Upon identification of the mass, the patient and his family were immediately directed to the pediatric emergency department (ed), and the patient was started on iv dexamethasone.Both pediatric neurosurgery and pediatric hematologyoncology were consulted.Due to the suspected hypervascularity of the lesion, and as the leading preoperative differential consideration based off the imaging characteristics was an aggressive hemangioma, prior to surgery the patient underwent an angiogram with the intent to preoperatively embolize the lesion.  the endovascular neurosurgeon initially localized the artery of adamkiewicz to left t12 radicular artery, and subsequently catheterized the left t10 radicular artery in anticipation of embolization.Prior to initiating the embolization, a selective injection through the vessel demonstrated what appeared to be an accessory/duplicated artery of adamkiewicz.As such, the right t10 radicular artery was then selectively catheterized and 4 ml of onyx-18 was injected into the lesion.The embolization was terminated when a small amount of reflux of contrast was identified in the contralateral (left) radicular artery.After the angiogram, the patient underwent surgical resection of the lesion.This was accomplished by performing a t10 corpectomy/laminectomy/medial facetectomy with placement of an expandable cage at t10.Even with adequate pre-operative embolization there was still significant intraoperative blood loss (2.5 l), required four units of intraoperative packed red blood cells and two units of fresh frozen plasma.The patient also underwent arthrodesis of t8-t12 using both surgical instrumentation and bone allograft.The patient was discharged to an inpatient rehabilitation center following his hospitalization.At the time of this report (approximately 2 months after his surgery) the patient is able to ambulate independently without orthotic or assist device, and has had no falls.His gait is slow and sometimes off-balance, which has been improving.He continues to undergo physical therapy.

Manufacturer Narrative

G2: citation: authors: sahajwalla, d., vorona, g., tye, g., harper, a., richard, h., sisler, i., ellett, m., cameron, b., rivet, d., urbine, j.Aggressive vertebral hemangioma masquerading as neurological disease in a pediatric patient.Radiology case reports 5 2021.Doi:10.1016/j.Radcr.2021.02.023.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

• Brand Name: ONYX
• 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: 17724885
• MDR Text Key: 323153940
• Report Number: 2029214-2023-01644
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2023

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
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/11/2023
• 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): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male