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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC / MICRO THERAPEUTICS, INC., DBA EV3 NEUROVASCULAR MEDTRONIC 4 X 20 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC / MICRO THERAPEUTICS, INC., DBA EV3 NEUROVASCULAR MEDTRONIC 4 X 20 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-20
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2020
Event Type  Injury  
Event Description
The pipeline deployed without incident. During the recapture of the delivery system the distal wire tip separated from the rest of the delivery system. Both pieces were already fully inside of the microcatheter at that time. That separation occurred proximal to the proximal bumper. The microcatheter, including the 2 pieces of the delivery system inside, was withdrawn from the pt without incident. No pt injury or change in case procedure occurred due to the separation. There has been a recall on the same product but different lot numbers. The lot numbers that are on recall start with a9 and this lot number starts with a8. Fda safety report id# (b)(4).
 
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Brand NameMEDTRONIC 4 X 20 PIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC / MICRO THERAPEUTICS, INC., DBA EV3 NEUROVASCULAR
MDR Report Key9810740
MDR Text Key183118964
Report NumberMW5093626
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-20
Device Lot NumberA837027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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