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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 Activation, Positioning or SeparationProblem (2906)
Patient Problem Stenosis (2263)
Event Date 11/15/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that a patient underwent a procedure for pipeline flow diversion implantation to treat an aneurysm. There were no device or procedure issues noted. At 180-day follow-up on (b)(6) 2019, imaging showed residual aneurysm (raymond roy class 3). No action was taken at that time.  1 year follow up imaging performed on (b)(6) 2020 showed residual neck (raymond roy class 2) and parent artery stenosis >25-50%. Aspirin was continued an no other further action was taken at that time. Additional follow up  for digital subtraction angiography (dsa) imaging performed on (b)(6) 2020 showed residual aneurysm neck (raymond roy class 2) and parent artery stenosis >50-75%; the patient also experiencing associate symptoms. The patient underwent a retreatment procedure on (b)(6) 2021 in which an additional non-medtronic flow diversion stent was implanted to address the residual aneurysm/residual aneurysm neck.
 
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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 Key11527533
MDR Text Key241402400
Report Number2029214-2021-00304
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
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/13/2019
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberA359261
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 Received03/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/13/2016
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: 03/19/2021 Patient Sequence Number: 1
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