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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-450-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hydrocephalus (3272)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information of evidence of hydrocephalus in the mri performed at 6 month follow up with indication of nch treatment. Procedure for saccular sidewall aneurysm on the left internal carotid artery. The maximum aneurysm diameter is 18 mm. Dome height is 18mm. Dome width 10mm. Neck size 7mm.   it was indicated the event had a causal relationship to the procedure. The patient was hospitalized and the issue resolved.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12281976
MDR Text Key265205991
Report Number2029214-2021-00979
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2019
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberA359898
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/14/2016
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: 08/05/2021 Patient Sequence Number: 1
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