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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-30
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/25/2020
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 after the pipeline stent was in place, the tip of the stent could not be opened normally after repeated adjustments. A replacement device was used to complete the procedure. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results showed slow blood flow. The patient was undergoing surgery for treatment of a fusiform, unruptured, posterior circulation dissecting aneurysm with a max dia meter of 14 mm and a 10 mm neck diameter. It was noted the patient's vessel tortuosity was normal. Dual antiplatelet therapy (dapt) was administered and the platelet reactivity units (pru) level was unknown.
 
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Brand NamePIPELINE FLEX
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 Key11094953
MDR Text Key225564969
Report Number2029214-2020-01371
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-30
Device Catalogue NumberPED-450-30
Device Lot NumberB104392
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2020
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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