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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-20
Device Problems Activation, Positioning or SeparationProblem (2906); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2017
Event Type  Malfunction  
Event Description

Stent introduced into patient did not deploy correctly and had to be recaptured. The distal end of the stent would not expand. A second attempt did not remedy the situation. A new stent had to be opened and it did work correctly. Potential for harm was present, but no harm noted.

 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
MDR Report Key6383419
MDR Text Key69220148
Report Number6383419
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberPED-500-20
Device Catalogue NumberPED-500-20
Device LOT NumberA254080
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2017
Event Location Hospital
Date Report TO Manufacturer03/01/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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