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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 PED2-250-20
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Event Date 03/29/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis, as it was implanted in the patient. Since the device was not returned, we are unable to perform further root cause analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that an adjunctive device was used to stabilize and bridge the distal end of the pipeline, which slipped down just after the deployment. No patient injury was reported to have occurred.
 
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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 Key7492746
MDR Text Key107573432
Report Number2029214-2018-00378
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
P100018.S033
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 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/06/2020
Device Model NumberPED2-250-20
Device Catalogue NumberPED2-250-20
Device Lot NumberA487498
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 Received09/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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