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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-16
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Aneurysm (1708)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the core lab procedure imaging showed that aneurysm neck coverage with the pipeline was not achieved. The patient did not experience any further injury or complications. The devices were prepared according to the instructions for use (ifu). Angiographic results post procedure showed that wall apposition was achieved, aneurysm occlusion raymond and roy class 3, and that neck coverage was not achieved. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ica. The max diameter was 4mm, and the neck diameter as 4mm. The landing zone was 4mm distal and 5mm proximal. Dual antiplatelet treatment had been administered, and the pru level was 149. Ancillary devices include a phenom 27 microcatheter.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key11304938
MDR Text Key231213902
Report Number2029214-2021-00158
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
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 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/06/2020
Device Model NumberPED2-450-16
Device Catalogue NumberPED2-450-16
Device Lot NumberA425188
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 Received02/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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