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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER
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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Hematoma (1884); Ischemia (1942); Pseudoaneurysm (2605)
Event Date 05/29/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that a left hemicranial headache, retro-peritoneal hematoma, and a pseudo-aneurysm of the common femoral artery started post-procedure and the headache was treated was medication.The relatedness to the procedure was stated to be probable and unlikely related to the device.
 
Manufacturer Narrative
A2.Patient information - age at event - additional information a3.Patient information - set - additional information g4.Date manufacturer received - additional information g7.Type of report - follow up h2.Follow-up type - additional information h6.Patient codes - additional information h10.Additional manufacturer narrative - additional information the following additional information was received: the patient was undergoing embolization treatment of a saccular aneurysm measuring 11mm x 8.3mm x 6mm x 3.8 (dia, hgt, wth, neck) located in the c6 bifurcation branch of the left internal carotid artery (ica).This distal and proximal landing zone was 3mm x 4.6mm.The tortuosity of the patient¿s vasculature were not provided.It is not known if there are any intervention or plans for intervention for the pseudo-aneurysm and hematoma.Source document review identified, from post procedure specialist opinion letter dated 01-jul-2019, that that the patient had left-sided subfoveal localized ischemia on likely embolus during the cerebral aneurysm embolization procedure.Dfe: small ischemic area visible on temporal to upper foveola.The ischemia was localized by arterial occlusion in the left eye and is now improving.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 noted that the patient's headache had a causal relationship to procedure, possible relationship to device, and not related to dapt.The patient's retro-peritoneal hematoma was updated to serious adverse event of hematoma at access site, causal relationship to procedure, not related to device, and possibly related to dapt.The patient also experienceda retinal emboli which was determined to be a retinal artery embolism, listed as causal relationship to procedure, possible relationship to device, and not related to dapt.
 
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 informational received reported that the action taken with the study treatment was medication.The outcome status was listed as not recovered/not resolved.The retinal emboli was listed as causal relationship to study device and not related to the study procedure.
 
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.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key9571087
MDR Text Key174462491
Report Number2029214-2020-00024
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Type of Report Initial,Followup,Followup,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/16/2019
Device Model NumberPED-450-20
Device Catalogue NumberPED-450-20
Device Lot NumberA390889
Was Device Available for Evaluation? No
Date Manufacturer Received02/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age37 YR
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