MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

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

Patient Problems Foreign Body Reaction (1868); Foreign Body In Patient (2687); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Swelling/ Edema (4577)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

The reported patient age is representative of the median age of all the patient included in the study.The reported patient gender of female is representative of the majority of patients in the study.If information is provided in the future, a supplemental report will be issued.

Event Description

Moreno estébanez, a., luna rodríguez, a., pérez concha, t., fernández maiztegi, c., freijo guerrero, m.Del m., díaz cuervo, i., ugarriza serrano, i., labayen azparren, i., fondevila monso, j., gil garcía, a., manso del caño, x., gonzález-pinto gonzález, t., agirre beitia, g., <(>&<)> gonzález díaz, e.(2021).Symptomatic intracranial embolic foreign-body reactions after endovascular neurointerventional procedures: a retrospective study in a tertiary hospital.Clinical neurology and neurosurgery, 200.Https://doi.Org/10.10 16/j.Clineuro.2020.106323.Medtronic review of the literature article found that a single facility review of a total of 7446 neurointerventional procedures performed between 2013 and 2019, 11 cases were identified with an incidence of 0.14 %.The procedures were therapeutic in all: ten aneurysm embolization/isolation, one acute ischemic stroke recanalization.Intracranial coils, stent or both were placed in all.Symptoms appeared during the following one day to fourteen months.Brain magnetic resonance imaging (mri) showed edematous, contrast-enhancing lesions scattered through the vascular territory of the canalized vessel.Brain biopsy confirmed the diagnosis in one case and was supportive in another one.Eight patients received immunosuppression.No treatment was started in two.After a median time of follow-up of 3.5 years, five patients are totally asymptomatic.One patient presents slight weakness.Four patients have remote symptomatic seizures, but they had comorbid lesions (previous stroke, intracranial hemorrhage, biopsy needle-track¿s gliosis).Follow-up mri showed significant improvement in all the cases, with complete resolution in five.Non-symptomatic lesion fluctuation was observed in three cases.Two patients experienced symptomatic rebounds.It was unknown in the cases what devices was the origin of the potential polymers which were believed to cause the embolizations.The conclusion of the study was that intracranial embolic foreign-body symptomatic reactions are uncommon complications of neurointerventional procedures.Polymer-coats may peel-off the surface of catheters and devices during endovascular procedures and might lead to brain inflammatory foreign-body reactions.Diagnostic angiographies might have lower risk of polymer-embolization than therapeutic procedures.This entity¿s early recognition enables making proper diagnosis and treatment decisions.The cases included 4 procedures in which axium coils were used, including one patient who underwent a second coiling procedure.One patient who underwent a coiling procedure with axium coils had balloon assisted procedure with a hyperform balloon catheter; this patient also experienced focal seizures.One of the axium patient was lost to follow-up.The other two patients were treated with medication and had complete resolution of the embolizations over time.3 of the cases in the study were with patient who had pipelines implanted and two of these procedures also involved the use of a navien catheter.Two of these patients had focal seizures and were treated with medication; one of these patient developed acute renal failure related to the long-term medication treatment.One patient received no additional treatment and the embolization resolved completely over time.

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.

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 12069694
• MDR Text Key: 265205133
• Report Number: 2029214-2021-00776
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• 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
• Patient Age: 47 YR
• Patient Sex: Female