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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 PED2-300-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Dizziness (2194); Irritability (2421)
Event Date 03/04/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the patient experienced a headache, secondary antiplatelet medication, and nicotine withdrawal with an onset date of (b)(6) 2020. It was noted the event was possibly related to the procedure performed on (b)(6) 2020. The patient was hospitalized, and treated with medications. The event resolved on (b)(6) 2020. The patient was undergoing surgery for treatment of a saccular aneurysm of the right anterior communicating (acom) artery with a max diameter of 5. 0mm and a 4. 7mm neck diameter. Additional information received reported that the event term was changed to ¿localized headache¿. Medtronic assessment to device relatedness is positive additional information received reported the patient experienced ongoing headaches, dizziness, and irritability after the procedure. The site assessed the event as not related to the device, and possibly related to the procedure.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12203222
MDR Text Key262676126
Report Number2029214-2021-00894
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/03/2021
Device Model NumberPED2-300-10
Device Catalogue NumberPED2-300-10
Device Lot NumberA701620
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 Received07/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/04/2018
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: 07/21/2021 Patient Sequence Number: 1
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