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

Model Number UNK-NV-AXIUM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Thromboembolism (2654); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 07/17/2013

Event Type  Death  

Manufacturer Narrative

Sex.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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

Tähtinen, o.I., manninen, h.I., vanninen, r.R., haapanen, a., seppänen, j., niskakangas, t., rinne, j., keski-nisula l.Stent-assisted embolization of recurrent or residual intracranial aneurysms.Interventional neuroradiology 2013.55:1221¿1231.Doi: 10.1007/s 00234-013-1234-x summary: intracranial stents have theoretical advantages in the treatment of wide-necked intracranial aneurysms, but the usability of intracranial stents in the retreatment of recurrent intracranial aneurysms is relatively unknown.In this study, we aim to evaluate the safety and efficacy of stentassisted embolization in the retreatment of recurrent or residual intracranial aneurysms.Retrospective evaluation was carried out for 55 consecutive patients (17 men and 38 women; mean age 51.5 years), with 56 recurrent or residual intracranial aneurysms electively retreated with stent-assisted embolization.The technical success rate was 91 % (50/55 patients).Procedural complications were encountered with six patients (11 %).Angiographic and clinical follow-up datawere available for 51 patients (93 %), with a mean follow-up period of 28.1 months.No rebleedings were encountered during the study period.The clinical outcome was favorable in 50 patients (91 %), with a glasgow outcome score of 4 (n=14) or 5 (n=36) at the end of the study period.Poor clinical outcome correlated with very large (>2 cm) total aneurysm size (p=0.002), large (>10 mm) recurrent aneurysm size (p=0.011), and occurrence of periprocedural complications (p<(> <<)>0.001).Stent-assisted coil embolization is beneficial for the retreatment of wide-necked recurrent or residual intracranial aneurysms, but stability and permanent occlusion of the recurrent aneurysm is unlikely if the aneurysm exceeds 2 cm in diameter, the recurrent diameter of the aneurysm exceeds 10 mm, or if mass effect is present with the recurrent aneurysm.Reported events: finnish population can be directly extrapolated to other populations, since the risk of aneurysm rupture is higher in finnish and japanese populations compared to other countries procedural complications almost invariably resulted in permanent neurological deterioration (n=4) or death (n=1) of the patient; only the patient with retroperitoneal and intraabdominal hemorrhage recovered without sequelae.

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.

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

The following is a correction of the intra- or post-procedural outcomes noted.It is unclear how many procedures or events involved axium coils.- procedural complications were encountered in 6 patients, including 3 cases of perioperative aneurysm perforation, 1 case of postoperative retroperitoneal and intra-abdominal hemorrhage, and 2 cases in which an embolized large basilar tip aneurysm presented with progressive brain stem compression symptoms postoperatively.Procedural complications almost invariably resulted in permanent neurological deterioration (n=4) or death (n=1) of the patient; only the patient with retroperitoneal and intraabdominal hemorrhage recovered without sequelae.- intraprocedural adjunctive therapies were required in 5 patients: 2 cases of minor periprocedural thromboembolism successfully treated with intra-arterial abciximab, 2 cases of presumable iatrogenic vertebral dissections that were successfully stented, and 1 case where insertion of an additional intracranial stent was required due to suboptimal placement of the primary stent.Clinical sequelae or procedure-related radiographic findings were not detected in these patients postoperatively or during the available follow-up.- after the stent-assisted embolization, additional endovascular treatment was performed in 9 patients due to the additional coil compaction and regrowth of the recurrent aneurysm volume (n=7) or suboptimal initial occlusion of the recurrent aneurysm (n=2), including 1 case in which 2 additional embolizations were performed to a rapidly growing basilar tip aneurysm.However, an adequate angiographic result was not achieved in this patient; this patient was also one of the patients who developed brain stem compression symptoms from the embolized aneurysm.

• 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: 15924408
• MDR Text Key: 304895829
• Report Number: 2029214-2022-02066
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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?: No
• Date Manufacturer Received: 01/23/2023
• 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): Death; Required Intervention; Life Threatening; Disability
• Patient Age: 51 YR
• Patient Sex: Female