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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-400-35
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2020
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 failed to open at the distal end. The patient was undergoing a procedure for stent-assisted embolization of an aneurysm. Vessel tortuosity was minimal. It was reported the all devices were prepared and the catheter flushed per the instructions for use (ifu). When the pipeline was deployed, the distal end did not open. Multiple adjustments were attempted to get the pipeline to open without success. The physician became concerned that the repeated adjustments could damage the distal access catheter and the microcatheter so the entire system was removed and the devices were replaced. The procedure was then completed with the pipeline deployed normally and well adhered to the vessel wall. There was no harm or injury to the patient.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10837744
MDR Text Key216335496
Report Number2029214-2020-01126
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-35
Device Catalogue NumberPED-400-35
Device Lot NumberA877525
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 Received11/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/06/2019
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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