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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-425-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neuropathy (1983)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the patient had post procedure neurological focal deficit. As a result a retreatment procedure was performed, resulting in hospitalization and disability for the patient. The issue was unlikely related to the device and had a causal relationship to the study procedure. The patient was undergoing treatment of a right mca sidewall aneurysm with a max diameter of 40mm and a neck width of 23mm.
 
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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 Key11177713
MDR Text Key227050216
Report Number2029214-2021-00058
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,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/20/2020
Device Model NumberPED-425-25
Device Catalogue NumberPED-425-25
Device Lot NumberA479405
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 Received06/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2017
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: 01/15/2021 Patient Sequence Number: 1
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