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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 PED2-475-30
Device Problems Break (1069); Unintended Ejection (1234); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
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 flex with shield that deployed prematurely during delivery and was difficult to open fully. It was reported that when the device was being deployed, it was prematurely separated from the pushwire and deployed. The pipeline was able to be release further by withdrawing the microcatheter as the pipeline was already partially anchored. However, the opening was not sufficient. Post-dilation was attempted unsuccessfully but other manipulation attempts allowed for moderately good opening of the stent and procedure was completed. No patient symptoms were reported.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12639880
MDR Text Key276660361
Report Number2029214-2021-01284
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100018 S033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-30
Device Catalogue NumberPED2-475-30
Device Lot NumberB053343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2020
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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