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 Paralysis (1997); Loss of Vision (2139); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 01/05/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: gui s., chen x., wei d., deng d., you w., meng x., lv j., feng j., tang y., yang s., chen t., liu p., ge h., jin h., liu x., jiang y., feng w., li y.Long-term outcomes and dynamic changes of in-stent stenosis after pipeline embolization device treatment of intracranial aneurysms.Neurovascular surgery 2023.Doi: 10.1136/jnis-2022-019680.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.See manufacturer report #2029214-2023-01861, 2029214-2023-01864, 2029214-2023-01863, and 2029214-2023-01862 for another report from this article.A.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.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.

Event Description

Gui s., chen x., wei d., deng d., you w., meng x., lv j., feng j., tang y., yang s., chen t., liu p., ge h., jin h., liu x., jiang y., feng w., li y.Long-term outcomes and dynamic changes of in-stent  stenosis after pipeline embolization device treatment  of intracranial aneurysms.Neurovascular surgery 2023.Doi: 10.1136/jnis-2022-019680.Literature review found multiple complications associated with pipeline embolization device treatment of intracranial aneurysms in which a pipeline stent, marksman catheter, and axium coil were used.The authors reviewed 459 cases patients being treated for intracranial aneurysms using a pipeline stent, marksman catheter, and axium coil.Of the 459 patients, the average age was 54 years, 151 were male and 308 were female.The following intra- or post-procedural outcomes were noted: 1) 2 patients died from brainstem infarction because of the in stent stenosis (iss) that developed into basilar artery occlusion.2) 4 patients who had iss experienced hemiplegia.3) 1 patient who had iss experienced hemianopia.4) 10 patients developed severe iss.5) 18 patients developed parental artery occlusion 6) 32 patients experienced mild iss.7) 9 patients who experienced iss spontaneously recovered.

• 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: 17822359
• MDR Text Key: 324319832
• Report Number: 2029214-2023-01865
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 08/30/2023
• 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 Age: 54 YR
• Patient Sex: Female