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

Model Number 105-7100-060

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

Patient Problems Ischemia (1942); Muscle Weakness (1967); Vasoconstriction (2126); Lethargy (2560); Hydrocephalus (3272); Speech Disorder (4415); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

B3.Earliest date of publication/online publication date is used for reported event date.A separate report will be submitted for the marathon microcatheter used in the index procedure.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

Miller, b.A., spears, r.C., hines, t.K., alhajeri, a., fraser, j.F.(2020).Republished: a lumbar arteriovenous fistula presenting with intraventricular hemorrhage and hydrocephalus.Journal of neurointerventional surgery, 12(5), e5.Https://doi.Org/1 0.1136/neurintsurg-2019-015631.Rep medtronic review of the literature article found a case review of the 6-year-old male patient who presented with progressive lethargy without focal neurological deficit; the patient had spontaneously lost consciousness but quickly awoke with reported headache and right lower extremity (rle) pain.Non-contrast head computed tomography (ct) revealed hydrocephalus and sulcal effacement; a small hyperdensity in the patient third ventricle was suspicious for hemorrhage but there were no other observed signs of hemorrhage.An external ventricular drain was placed.The patient underwent magnetic resonance imaging (mri) and venography revealed incomplete filling of the left transverse sinus.Heparin was started due to suspicion of venous sinus thrombosis, however, follow-up short interval ct venogram (ctv) showed atresia but no sinus thrombosis so heparin was stopped.Follow-up ct/ctv showed increased intraventricular hemorrhage (ivh) without subarachnoid hemorrhage (sah).With no explanation for the patient's hydrocephalus, the patient underwent magnetic resonance imaging (mri) of the entire spine and diagnostic angiogram which confirmed an arteriovenous fistula (avf) at the t12-l1 supplied from the right l1 and left l2 radicular arteries with a dilated venous pouch.The patient underwent an endovascular transarterial embolization procedure.A marathon microcatheter was advanced through a non-medtronic diagnostic catheter along non-medtronic guidewire into the right l1 artery and into the specific arterial branch.The avf was embolized with onyx-18.There was no reported device malfunction/deficiency or intra-operative issue.Post-embolization angiogram showed no residual filling of the avf.Post-operatively, the patient developed urinary incontinence and underwent urodynamic testing which revealed high bladder pressures and increased volumes which was attributed to spinal cord edema after avf treatment.The patient was started on dexamethasone and urinary function improved during hospitalization.12 days after presentation, the patient developed acute right arm weakness and aphasia.Mri/mra revealed bilateral middle cerebral artery (mca) and basilar artery vasospasm with left basal ganglia ischemia.The patient was taken for emergent angiogram and treatment successfully with intra-arterial verapamil.Over the next 13 days, weakness, aphasia, and arterial velocities normalized and mra confirmed resolutionof vasospasm.After weaning of the external ventricular drain, the patient became lethargic.Therefore, a ventriculoperitoneal shunt was placed on in-hospital day 29.The patient was discharged on day 34 after admission.The patient was ambulatory with a rolling walker and had returned to cognitive baseline.Follow-up noted: "at 3 weeks post-discharge, his urinary incontinence had completely resolved and his only residual deficit was imbalance.At 6 months, he was neurologically intact with no weakness, ataxia, or urinary symptoms.He returned to school and all other normal activities.Repeat angiogram at 1 year revealed no recurrent or residual avf.".

• Brand Name: ONYX AVM
• 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: 17765485
• MDR Text Key: 323623038
• Report Number: 2029214-2023-01750
• 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: Foreign,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: 105-7100-060
• Device Catalogue Number: 105-7100-060
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male