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 Cerebrospinal Fluid Leakage (1772); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Perforation of Vessels (2135)

Event Date 01/24/2022

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: brinjikji, w., garza, i., whealy, m., kissoon, n., atkinson, j.L.D., savastano, l., madhavan, a., c utsforth-gregory, j.Clinical and imaging outcomes of cerebrospinal fluidvenous fistula embolization.Journal of neurointerventional surgery 14(10):953-956 2022.Doi:10.1136/neurintsurg-2021-018466.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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.

Event Description

Brinjikji w, garza i, whealy m, et al.Clinical and imaging outcomes of cerebrospinal fluid-venous fistula embolization.Journal of neurointerventional surgery.2022;14(10):953-956.Doi:10.1136/neurintsurg-2021-018466.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to report outcomes of spontaneous intracranial hypotension (sih) patients who underwent transvenous embolization of cerebrospinal fluid-venous fistulas (csfvfs) confirmed on digital subtraction myelography (dsm).Patients with sih secondary to high probability csfvf diagnosed on dsm were retrospectively reviewed with a prospectively collected database.A total of 40 patients were included (29 female, 11 male).Mean age was 57.4 years.For embolization of the fistulas, the approach was to selectively catheterize the paraspinal vein that was identified as draining the fistula on the dsm and then embolize that vein using onyx.The article states the following technical issues: -asymptomatic tiny onyx emboli to the lungs occurred in 3 patients  the following intra- or post-procedural outcomes were noted: -persistent local site pain occurred in 12 patients, but no patient required long-term medical therapy and in no case was it debilitating.-suspected rebound intracranial hypertension requiring medical intervention with acetazolamide occurred in 7 patients.In all patients, they developed severe headaches when in the recumbent position, which improved when upright, which was refractory to medical therapy with non-steroidal anti-inflammatory drugs or acetaminophen.Only two underwent a lumbar puncture to confirm an elevated opening pressure, and the rest were managed remotely without diagnostic tests confirming the presence of rebound hypertension.  -three patients had new leaks discovered at different levels on dsms after embolization.Two patients were retreated, one enjoyed persistent improvement and one continues to suffer from headache and other sih symptoms.The third is pending re-treatment.  -two patients were found to have a persistent csfvf from the level of the embolization on a follow-up dsm.One was treated successfully and one was treated but continues to experience symptoms and brain sag and is undergoing further evaluation to identify the site of the leak.-asymptomatic tiny onyx emboli to the lungs occurred in 3 patients (7.5%).-all awake patients reported some intraoperative pain during onyx injection, centered around the level of the embolization.-on postoperative ct, onyx was seen to have been successfully delivered into the foraminal vein in 36 patients.In four patients it was only in the paraspinal vein.-two cases of paraspinal vein perforation, both treated with onyx embolization with no immediate clinical sequelae -one patient had clinical worsening.

• 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: 17608728
• MDR Text Key: 321801753
• Report Number: 2029214-2023-01471
• 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: 08/23/2023

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: 08/03/2023
• Initial Date FDA Received: 08/23/2023
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female