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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 PED2-400-20
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2020
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 middle section of the pipeline failed to open when it was planned to be deployed. It was unknown if the device was placed in a bend, less than 50% was deployed when it failed to open, unknown how many resheathing attempts were made, and unknown if any additional steps were taken in an attempt to open the stent. The pipeline was removed from the patient and a replacement device was used to complete the procedure. It was unknown if the devices were prepared as per the instructions for use (ifu), and there were no patient symptoms or complications reported with the event. The patient was undergoing surgery for treatment of an unruptured aneurysm with moderate vessel tortuosity.
 
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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 Key10549924
MDR Text Key207523100
Report Number2029214-2020-00943
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/16/2021
Device Model NumberPED2-400-20
Device Catalogue NumberPED2-400-20
Device Lot NumberA708515
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 Received09/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/17/2018
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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