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 Intracranial Hemorrhage (1891); Hemorrhagic Stroke (4417); Aspiration Pneumonitis (4455)

Event Date 10/07/2020

Event Type  Death  

Manufacturer Narrative

G2: citation: authors: kan, p., maragkos, g.A., srivatsan, a., srinivasan, v., johnson, j., burkhardt, j.-k., robinson, t.M., salem, m.M., chen, s., riina, h.A., tanweer, o., levy, e.I., spiotta, a.M., kasab, s.A., l.Middle meningeal artery embolization for chronic subdural hematoma: a multi-center experience of 154 consecutive embolizations.Neurosurgery 2 2021.Doi:10.1093/neuros/nyaa379 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.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

Kan p, maragkos ga, srivatsan a, et al.Middle meningeal artery embolization for chronic subdural hematoma: a multi-center experience of 154 consecutive embolizations.Neurosurgery.2021;88(2):268-277.Doi:10.1093/neuros/nyaa379.Medtronic literature review found a report of patient complications in association with onyx.The purpose of this article was to  determine the safety and efficacy of mma embolization.All consecutive patients who underwent mma embolization for chronic subdural hematoma (csdh) (defined as lesions with mixed hyper, iso, and hypodensity) as primary or rescue treatment at 15 centers from (b)(6) 2018 to (b)(6) 2019 were included.A total of 138 patients undergoing 154 mma embolization procedures were included (mean age: 69.8, 29% female).The endovascular access point was either the femoral or radial artery.After securing access, a guiding catheter was placed in the proximal external carotid artery or distal common carotid artery, and a microcatheter was advanced into the main trunk of the mma for superselective angiography.Dangerous collateral vessels (lacrimal and petrous branches) were identified prior to embolization.If such collaterals were not present, the mma was embolized, either in its trunk (before the bifurcation) by some operators, or selectively in its frontal and parietal branches by others.Embolization materials included liquid embolics (onyx or n-butyl cyanoacrylate), coils (coils were only used in cases in which selective catheterization of the frontal and parietal branch was not possible and dangerous anastomosis was present), or particles (polyvinyl alcohol particles or embospheres), and the procedure was performed until flow stasis (absence of contrast opacification of the frontal and parietal branches) was observed.Embolization was considered technically successful when all target mma branches were embolized (stasis within both mma branches).During selective angiography of the mma, we tried to identify a cotton-like blushing inside the hematoma that corresponds to delayed enhancement of the subdural space and to eliminate that after embolization.Contrast leakage into the csdh identified on postoperative ct scanning suggested that the embolized vessels were feeding the capillaries in the membrane surrounding the collection.Postoperative ct was conducted within 24 h.Liquid embolics were used in 37 procedures and liquid embolics and coils were used in 2 procedures.The following technical issues were noted: -flow of embolization materials into the ophthalmic artery through the meningoophthalmic connection or into the vasa nervorum of the facial nerve occurred in one patient in this series the following intra- or post-procedural outcomes were noted: -six patients died within the follow-up period.Four patients died of causes unrelated to the procedure.Two of these died of pre-existing acute myelogenic leukemia and 1 of aspiration pneumonitis.One patient presented to the emergency department 2 months after the procedure because of ischemic bowel disease unrelated to the embolization and died of sepsis.One patient¿s sdh worsened 1 week after mma embolization.Consequently, she developed a right middle cerebral artery stroke and pneumonia, was made comfort measures only (cmo), and expired.Another patient subsequently had worsening sdh causing 6-mm midline shift (mls).After a prolonged hospital course, she then developed aspiration pneumonia and was made cmo.-9 cases recurred within follow-up requiring further surgical treatment.At least 50% reduction in csdh thickness, 70.8% of patients achieved at least this amount of reduction during 90 day or at last follow-up.140 patients had an improvement in their csdh thickness, whereas 8 had worsening.In total, 134 patients had at least 20% csdh thickness decrease, 109 had at least 50% improvement, 80 had at least 70% improvement, and 49 had complete sdh resolution.-13 complications were observed.There were 10 cases of hematoma recurrence or increase, despite the procedure, 7 of which were symp tomatic.There was 1 case of asymptomatic mma rupture during the procedure, 1 postoperative seizure, and 1 patient with right-sided facial droop.2 patients had persistent headaches.-30 patients improved their nihss, whereas 4 worsened.79 had no difference.-44 patients had improvement in their mrs, whereas 11 had worsening.46 had no difference.

• 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: 17764750
• MDR Text Key: 323610862
• Report Number: 2029214-2023-01747
• 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: 09/18/2023

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: 08/24/2023
• Initial Date FDA Received: 09/18/2023
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male