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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 PED2-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Transient Ischemic Attack (2109); Blurred Vision (2137)
Event Date 01/12/2020
Event Type  Injury  
Manufacturer Narrative
This event is reported at this time because additional information received triggered reassessment. At the time the event was initially reported, the pipeline flex with shield was not approved in the us and as there was nothing to indicate the device malfunctioned, the event was not reportable at that time. This device is now marketed in the us and, therefore, triggered a reportable event when reassessed with new information received. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following report: site reported a non-serious device and procedure related adverse event (ae) of possible transient ischemic attach (tia). Onset post-procedure on (b)(6) 2020. Symptoms were described as ¿headache and blurred vision¿. Diagnostic tests results were normal. No treatment given. Event outcome is not reported yet. This event has been assessed as procedure and device related. The aneurysm was in the right, anterior inferiorcerebellar artery (aica), the max diameter of the aneurysm was 8 mm. Additional information received clarified that the headaches began on (b)(6) 2020 and resolved two days later. The patient was treated with paracetamol. An angio ct-1 scan on (b)(6) 2020 was negative. The event was assessed as possibly related to the device, procedure, study disease, and patient's underlying disease/condition. Aneurysm occlusion status was raymond and roy class 3 at the 1-yr follow-up dsa/ 3d dsa/ mr/ mra imaging on (b)(6) 2020. Aneurysm oc clusion status was raymond and roy class 3 at the 2-yr follow-up cta imaging on (b)(6) 2021. It is unsure if there was complete neck coverage at these visits. No impact on patient or medical intervention/ treatment was 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 Key13460946
MDR Text Key289196288
Report Number2029214-2022-00160
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2022
Device Model NumberPED2-400-16
Device Catalogue NumberPED2-400-16
Device Lot NumberA760119
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/02/2019
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: 02/04/2022 Patient Sequence Number: 1
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