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 Hematoma (1884); Paralysis (1997); Foreign Body In Patient (2687)

Event Date 06/22/2022

Event Type  Injury  

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 Description

B.Saway, w.Roth, c.Salvador, m.Amir essibayi, g.Porto, e.Dowlati, d.Felbaum, m.Rock, c.Withington, s.Desai, a.Hassan, w.Tekle, and a.Spiotta; journal of neurosurgery; 2023; 139:131¿138; subdural evacuation port system and middle meningeal artery embolization for chronic subdural hematoma: a multicenter experience; doi: 10.3171/2022.10.Jns221476.Medtronic recieved information in a literature article of patients possibly treated with onyx having complications.The purpose of the article was to present a multi-institutional retrospective case series that assessed the safety, efficacy, and complications of subdural evacuation port system (seps) and middle meningeal artery (mma) embolization for chronic subdural hematoma (csdh).The study performed a retrospective chart review of all patients who underwent seps placement and mma embolization during the same hospital stay for the treatment of csdh at three institutions beginning in 2018 and ending in 2021. one hundred patients with 136 csdhs and a median age of 73 years underwent both seps placement and mma embolization.Male/female ratio of 2.13:1.Initial glasgow coma scale scores were between 14 and 15 in 81% of patients and between 9 and 13 in 14%.The median initial midline shift (mls) was 7 mm, with subdural hematoma (sdh) in the left hemisphere (lh) in 30% of patients, right hemisphere (rh) in 34%, and bilateral hemispheres (bh) in 36%. the embolization materials included particles in 58% of patients, onyx in 29%, and particles with coils in 13%.Radiological outcomes: mls decreased postoperatively in 89% of patients, with a mean decrease of 3.63  and a post-operative median mls of 3 mm.Only 3 patients showed increased mls, and 8% had no change after treatment.In total, 84.8% of lhsdhs and 87.1% of rhsdhs decreased in size, whereas 6.1% and 5.7% of these hematomas increased in size.Among bhsdhs that concurrently underwent embolization on both sides, 69% decreased in size on both sides, 8% decreased in size on one side, and 5% increased in size on one side.No patient showed an increase in size of bhsdh.Ninety-two (92%) patients underwent follow-up noncontrast computed tomography (ncct) with a median follow-up of 1.9 months.Overall, 92% of patients demonstrated decrease in mls on follow-up.Clinical outcomes:  primary outcomes:four (4%) patients experienced posttreatment complications: 1 (1%) patient had complications associated with embol ization (facial nerve palsy), and 3 had acute sdh due to seps placement.Surgical intervention was required in 2 (2%) patients owing to treatment failure, and repeated seps was required in 11 (11%) secondary to csdh re-accumulation or device misplacement.Sixty-four (64%) patients had good postoperative functional outcomes (mrs score = 2), which improved for 53 (53%) patients. the overall mortality rate was 2% due to treatment-unrelated causes.Readmission due to complications from csdh was required in 9 (9%) patients.Secondary outcomes: at discharge, patients had the following dispositions: 44.4% were discharged home without health service, 18.2% home health service, and 36.4% acute rehabilitation.One patient died of covid-19 postoperatively.The median (iqr) length of hospital stay was 6 (4¿9) days, with a breakdown as follows: 6 (4¿11) days for patients with lhsdh, 5 (3¿10) days for patients with rhsdh, and 6 (5¿8) days for patients with bhsdh. good mrs score on admission was associated with increased odds of functional improvement on follow-up.Use of onyx and particles plus coils were both associated with increased odds of functional improvement on follow-up.The use of onyx was associated with improvement in mrs scores compared with particles plus coils.

• 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: 18108210
• MDR Text Key: 327874561
• Report Number: 2029214-2023-02189
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/09/2023

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: 10/31/2023
• Initial Date FDA Received: 11/09/2023
• 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: 73 YR
• Patient Sex: Male