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 Cyst(s) (1800); Headache (1880); Muscle Weakness (1967); Paresis (1998); Swelling/ Edema (4577)

Event Date 12/26/2012

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

Grandhi, r., miller, r.A., zwagerman, n.T., lunsford, l.D., <(>&<)> horowitz, m.(2014).Perianeursymal cyst development after endovascular treatment of a ruptured giant aneurysm.Journal of neuroimaging¿: official journal of the american society of neuroimaging, 24(5), 515¿517.Https://doi.Org/10.1111/jon.12018 medtronic review of the literature article found that a 51 year-old male patient underwent a stent + coiling embolization procedure in january 2009 to treat a ruptured 27 mm right internal carotid artery bifurcation aneurysm.Axium coils were implanted in the procedure as well as a non-medtronic stent.The patient underwent periodic post-operative angiograms to screen for aneurysm regrowth.Over 3 years, the patient had four additional coil embolizations.In march 2012, he presented with progressively worsening headaches.Examination revealed mild left hemiparesis with 4/5 strength in the patient's left upper extremity (lue) and 4+/5 strength in left lower extremity (lle).The patient had normal strength on the right side.A head ct revealed the presence of a 4cm x 5cm low attenuation cystic lesion in the right basal ganglia which had not been observed 6 months prior.The patient underwent an awake, steriotactic cyst aspiration procedure to relieve symptoms and mass effect related to the cyst.The cytologic analysis of the aspirate revealed no cells, but a protein content of 5 ,000 mg/dl.The patient was discharged home a few days after cyst drainage.The only neurologic deficit that remained was minimal left arm pronation.A repeat head ct performed 4 weeks later demonstrated cyst recurrence.The patient was readmitted for stereotactic needle aspiration of the cyst followed by intracavitary phosphorus-32 (32p) radioisotope implantation.Prior to 32p implantation, contrast was injected into the cyst.The surgery proceeded without complication and the patient was discharged home with no new neurological deficits.Follow-up imaging at 2 months demonstrated no further cyst enlargement and the patient continues to exhibit minimal left-sided weakness.In review of the case, the site noted that while there was no evidence of a cyst on the head ct scan performed 6 months earlier, in comparing scans performed over 3 years, there was evidence of hypodensity within the basal ganglia as early as 5 months after his initial endovascular treatment.The radiologic pattern was most consistent with edema that became more prominent over time.We believe it is likely that the cyst arose secondary to an inflammatory process associated with the stent and coil mass.Also, given the use of a neck remodeling device and the slow radiographic progression, we can also suggest that the cyst resulted from hypoperfusion of the adjacent brain parenchyma due to altered autoregulation in the small vessels covered by the stent.This could lead to encephalomalacic changes, breakdown of the blood¿brain barrier and delayed cyst formation with a high protein content.

• 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: 15916604
• MDR Text Key: 304818406
• Report Number: 2029214-2022-02055
• Device Sequence Number: 1
• Product Code: HCG
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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: 11/23/2022
• 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): Disability; Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male