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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number UNK-NV-AXIUM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stenosis (2263); Convulsion/Seizure (4406)
Event Date 07/29/2022
Event Type  Injury  
Manufacturer Narrative
Iampreechakul p, wangtanaphat k, lertbutsayanukul p, siriwimonmas s.Revascularization of the internal carotid artery through the hypertrophied vasa vasorum in traumatic carotid-cavernous fistula previously treated by ligation of cervical carotid arteries: a case report.Surgical neurology international.2022;13:324.Doi:10.25259/sni_450_2022.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
Iampreechakul p, wangtanaphat k, lertbutsayanukul p, siriwimonmas s.Revascularization of the internal carotid artery through the hypertrophied vasa vasorum in traumatic carotid-cavernous fistula previously treated by ligation of cervical carotid arteries: a case report.Surgical neurology international.2022;13:324.Doi:10.25259/sni_450_2022.Medtronic literature review found a report of patient complications in association with axium coils.The purpose of this article was to described an extremely rare case of a 64-year-old woman who developed reconstitution of the occluded ica through hypertrophied vasa vasorum supplying recurrent traumatic carotid-cavernous fistula (tccf) previously treated by ligation of the internal and external carotid arteries.The article does not state any technical issues during use of the axium coil.The following intra- or post-procedural outcomes were noted:  - the left ica proximal to the fistula which was occluded with axium detachable coils.One month after surgery, the occluded ica was revascularized through hypertrophied vasa vasorum.Cerebral angiography was obtained and revealed the remaining of severe stenosis of the proximal ica with associated vasa vasorum and reduction in shunt flow and size of the dilated draining vein along the left cerebral hemisphere.In addition, the fistula received additional supply from the contralateral ica and left va.The patient underwent an additional coiling procedure to embolize the fistula.Post embolization course of the patient was uneventful.Follow-up cerebral angiography, obtained 1 year after the second embolization, confirmed no recurrence of the fistula.The patient had recovered completely from neurological deficits and had few episodes of seizure requiring the continuation of antiepileptic drug.
 
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
Additional information received reported that there was no problem with the axium coil.The product was failed to use because the patient was a very difficult case and complicated.The large aneurysm had very high flow.
 
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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 Key15890734
MDR Text Key304593192
Report Number2029214-2022-02026
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/19/2022
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 NumberUNK-NV-AXIUM
Device Catalogue NumberUNK-NV-AXIUM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2022
Initial Date FDA Received11/30/2022
Supplement Dates Manufacturer Received12/08/2022
Supplement Dates FDA Received12/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient SexFemale
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