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

Model Number UNK-NV-AXIUM

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

Ge h, jin h, li y, lv x.Extraction of a migrated coil from the enterprise stent strut using a solitaire ab stent.The neuroradiology journal.2016;29(6):470-472.Doi:10.1177/1971400916666556.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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

Ge h, jin h, li y, lv x.Extraction of a migrated coil from the enterprise stent strut using a solitaire ab stent.The neuroradiology journal.2016;29(6):470-472.Doi:10.1177/1971400916666556."medtronic literature review found a report of patient complications in association with an axium coil.The purpose of this article was to present a case of correction of coil misplacement in endovascular coil embolization of a cerebral aneurysm using the solitaire ab stent.The patient was referred to the hospital with two incidental aneurysms found on initial computed tomography angiography.Subsequent digital subtraction angiography confirmed the presence of two wide-necked aneurysms: a left 2-mm a1 aneurysm and a left 3-mm ophthalmic ica aneurysm arising from the medial side the article does not state any intra- or post-procedural adverse events.The following technical issues during use of the axium coil was noted: because of the size of the aneurysms, the wide-neck and the close relationship of the two aneurysms, a 4.5 mm  37 mm enterprise was used to cover these two aneurysms.After placement of a prowler select plus catheter (codman), an echelon-10 microcatheter was placed in the a1 aneurysm, and then a 2 mm x 20 mm coil was delivered while semi-releasing the enterprise stent.While the coil was detached, the coil displaced through the stent struts into the anterior cerebral artery.The enterprise stent was retrieved, and the select plus catheter was navigated distal to the migrated coil .The coil was retracted by placing a 4 mm x 15 mm solitaire ab stent. while retracting the deployed stent, the migrated coil moved into the stent.The doctors kept on retrieving the coil further and then partially sheathed the solitaire stent to entrap the coil within the stent.The select plus catheter, together with the solitaire stent and the migrated coil, were then retrieved out of the guiding catheter. the a1 aneurysm was re-treated with a 2 mm x 40 mm coil after placement of the enterprise stent, and the ophthalmic ica aneurysm was also coiled through the stent struts.The patient was neurologically intact after treatment.

• 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: 16075302
• MDR Text Key: 308530621
• Report Number: 2029214-2022-02218
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 12/19/2022
• 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