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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-275-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Paresis (1998); Thrombosis (2100)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline flex will not be returned for evaluation as it remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.Base on the reported information there were not any device issue during the use.The events occurred in post procedure and cause was unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through clinical study site that patient experienced stroke 7 days after post procedure.Relationship to procedure was ¿probable¿ and to device was ¿unlikely¿.Ae was recovered/resolved after 5 days.Site has not indicated any treatment which was queried.
 
Manufacturer Narrative
Part a3 patient information sex - additional information.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
A2: only patient's year of birth was reported.Therefore, the birthdate in this report should only be representative of the patient's year of birth.B5: updated with additional information received.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 pertains to previously reported event regarding a post-market study patient who experienced a stroke post-operatively on (b)(6) 2019 after pipeline was implanted on (b)(6) 2019.The event resulted in hospitalization of the patient who was discharged (b)(6) 2019.No additional medical or surgical intervention was described.Study sponsor assessment determined the event had a causal relationship with the pipeline device and possibly with the procedure.
 
Manufacturer Narrative
Correction: section b5 updated with all available new information which was accidentally omitted from report sent earlier today ((b)(6) 2021).Please noted.A2.Is only representative of patient year of birth, the full date-of-birth was not reported.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 pertains to previously reported event regarding a post-market study patient who experienced a stroke post-operatively on (b)(6) 2019 after pipeline was implanted on (b)(6) 2019.The event resulted in hospitalization of the patient who was discharged (b)(6) 2019.Site assessment determined the event had a causal relationship with the pipeline device and possibly with the procedure.The last follow-ups dated (b)(6) 2020 and (b)(6) 2021 both aneurysms were occluded with class 1 and 0-25% parent artery stenosis.All events were recovered/resolved and last mrs assessment was 1 on (b)(6) 2021.
 
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 indicated the site reported the patient experienced left hemiparesis and numerous acute bilateral points in hypersignal diffusion and flair on mr starting (b)(6) 2020 which were treated with anticoagulant medications with heparin.The adverse events were resolved on (b)(6) 2021.It was noted the adverse events were assessed to have a causal relationship with the dual antiplatelet therapy (dapt) therapy and a possible relationship to the device.
 
Event Description
Additional information received reported that the site assessed the event as not related to the device.
 
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 Key9582381
MDR Text Key174891126
Report Number2029214-2020-00042
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 company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/25/2021
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 Expiration Date07/08/2021
Device Model NumberPED-275-14
Device Catalogue NumberPED-275-14
Device Lot NumberA671981
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/10/2020
Initial Date FDA Received01/13/2020
Supplement Dates Manufacturer Received01/10/2020
03/08/2021
03/25/2021
03/25/2021
10/14/2021
Supplement Dates FDA Received01/13/2020
03/19/2021
03/27/2021
03/27/2021
10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age50 YR
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