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 Fistula (1862)

Event Date 09/18/2022

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

Silvio vera-vera, alfonso jurado-roman, raúl moreno, guillermo galeote; catheter cardiovasc intervention; 2023; 101:651¿654; percutaneous treatment of multiple fistulas associated with a giant aneurysm; doi: 10.1002/ccd.30570 medtronic received information that a patient treated with medtronic guide catheters and axium coil had complications. a 70-year-old woman, with previous history of chronic hypertension, was evaluated for palpitations.A chest-ray showed a mass close to the left ventricle and the aorta. to better study the lesion, a computerized tomography (ct) scan was performed.It showed a contrast-filled cavity of approximately 5 × 5.7 × 4.8 cm.  moreover, the ct also showed multiple coronary fistulas arising from the left anterior descending artery (lad), the right coronary artery (rca) and the right coronary sinus (rcs) that surrounds the aneurysm without being able to establish their drainage. a giant coronary aneurysm associated with multiple coronary fistulas was observed.There were four visible fistulae: one arising from the left main (lm), another one from the lad, the third one from the rcs, and a fourth smaller one from the proximal rca.Both left fistulas clearly drained into the aneurysm.Procedure: with an ar2 7-fr guide catheter (medtronic) was used to canulate the fistula of the rcs.Introducing a sion blue es guidewire, intravascular imaging (ivus) was performed to measure the vessel, obtaining a diameter of 3.5¿4 mm.A 6 × 11 mm amplatzer vascular plug 4 was preloaded into a 6-fr telescope guide-extensor catheter (medtronic) outside the patient, both were advanced simultaneously through the guidewire into the fistula and successfully deployed. then, a jr4 6-fr guide catheter was advanced into the rca.A sion-black guidewire was advanced into the small fistula from the rca.A microcatheter was advanced over the wire and two 3.5 mm × 10 cm ev3 axium prime coils (medtronic) were implanted sealing the fistula.With the same catheter, the fistula from the rcs was re-evaluated.The fistula was sealed but new small fistulas coming from the proximal segment had arisen.A 3.5 × 15 mm papyrus stent was implanted at this level, sealing them.Subsequently, an 8-fr ebu4 guide catheter (medtronic) was used to canulate the lm.A sion blue es was advanced into the middle part of the fistula arising from the lad.Ivus showed a vessel diameter of 5 × 3.5 mm.Using again a 6-fr telescope as a sheath, an 8 × 13.5 mm amplatzer vascular plug 4 was advanced and deployed into the fistula sealing it.Then, the sion blue es was advanced through the fistula coming from the lm and, using a microcatheter, four ev3 axium prime coils (medtronic), one of 5 mm × 20 cm and three of 5 mm × 15 cm, also one target 6 mm × 30 cm 360 coil was deployed sealing the fistula and concluding the procedure.The patient was discharged the day after the procedure.After 1-year follow-up, the patient did not have any other symptom and there was no expansion of the aneurysm in the chest x-ray nor in the ct scan, which also showed that it was thrombosed and that the fistulas remained closed.After these findings, as there were no symptoms, compression or interference with other structures, surgery of the aneurysm was not indicated, and further clinical and imaging follow-up was decided.

• 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: 18114374
• MDR Text Key: 327883653
• Report Number: 2029214-2023-02192
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• 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: 11/03/2023
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female