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 Problem Thrombosis/Thrombus (4440)

Event Date 10/10/2021

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

Linehan, v., dobson, j.L., dalton, a., hache, n., <(>&<)> gullipalli, r.(2022).Successful prophylactic embolization of a renal artery aneurysm during pregnancy.Annals of vascular surgery, 79, 437.E1-437.E5.Https://doi.Org/10.1016/j.Avsg.2021.07.030 medtronic review of the literature article found a 39-year-old female underwent a procedure for the treatment of an 1.4cm unruptured left renal artery aneurysm (raa) during second trimester of pregnancy after presenting in the emergency department with upper right quadrant pain at 9 weeks gestation.The procedure was delayed to the second trimester for fetal safety.For the procedure, a rebar 0.018" microcatheter was advanced over the guidewire through the guide catheter and positioned distally in the upper pole branch.A 5 x 30mm solitaire ab (sab) was then deployed across the aneurysm neck for stent-assisted coiling of the aneurysm.The same microcatheter was advanced on the guidewire through the sab stent struts to access the lower pole branch and raa.4 axium micro coils and 4 additional coils were successfully delivered and implanted to achieve aneurysm embolization.No device malfunctions were reported in the article information.At the end of the procedure some thrombus was visualized within the sab stent.The patient was immediately given 162mg of acetylsalicylic acid.After consultation with hematology and high risk obstetrics, the patient was also given 300mg of clopidogrel.Additionally gentle angioplasty was performed with a 4mm balloon across the thrombus within the stent repeat contrast injection showed good flow across the stent in the dominant artery supplying the left kidney.The patient had uneventful recovery and was discharged the following day on dual antiplatelet therapy (dapt) for 6 weeks to be stopped at least 1 month before the planned delivery date.6 week follow-up doppler ultrasound (us) showed well preserved renal cortex and good perfusion in the left kidney.The patient delivered a healthy baby at term via planned c-section.At 3 months post-partum, the patient had a follow-up enhanced abdominal ct which showed embolization of the aneurysm and patent renal artery with good perfusion of the left kidney.The patient was noted to have no adverse event in the 3 years of follow-up after the intervention.

• 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: 14804482
• MDR Text Key: 295068619
• Report Number: 2029214-2022-01058
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/24/2022

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-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/24/2022
• 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): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female