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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-500-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vasoconstriction (2126)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
The devices will not be returned as it remains in the patient. Base on the reported information there were not any device issue during the use. This is procedure related event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through clinical study that there was vasospasm occurred during procedure. The patient was treated with intravenous injection of nimotop and event resolved on same day.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key9530787
MDR Text Key187589730
Report Number2029214-2019-01308
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/23/2019
Device Model NumberPED-500-25
Device Catalogue NumberPED-500-25
Device Lot NumberA348792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/30/2019 Patient Sequence Number: 1
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