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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 PED2-500-18
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/15/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline device that was unable to be deployed completely and could not be resheathed after partial deployment. It was reported that an attempt was made to implant the pipeline. However, after the tip of the stent deployed a little, both insertion and removal of the stent could not be completed. It was suspected at the pushwire may have fractured. Because just a small portion of the device had been deployed, the pipeline was removed along with the phenom-27 microcatheter and the devices were replaced. The patient did not sustain any harm or injury during the procedure.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key9983108
MDR Text Key189075147
Report Number2029214-2020-00382
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/11/2022
Device Model NumberPED2-500-18
Device Catalogue NumberPED2-500-18
Device Lot NumberA846930
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2019
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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