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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 PED2-300-14
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Headache (1880); Blurred Vision (2137)
Event Date 03/02/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the a report the patient experienced a non-serious left frontal headache with onset date of (b)(6) 2020, no treatment was given, event was recovered/resolved on (b)(6) 2020. The patient also experienced visual symptoms: diplopia, worse on l) gaze and persistent blurry vision. Per the core lab image read at the procedure visit, neck coverage was not achieved. The patient's diplopia resolved on (b)(6) 2020 through ophthalmology review. The site assessment was reported as not related to device or procedure, but the assessment by the cec remained as possible related to device and causal relationship to device. The patient was treated for a left anterior communication artery, which was in the bifurcation branch. The aneurysm was saccular with a max diameter of 5. 5 mm. The aneurysm dome height was 5 mm, the dome width was 5 mm. The neck size was 4. 9 mm. The distal parent artery was 2. 8 mm and the proximal was 2. 9 mm.
 
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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 Key12337753
MDR Text Key267106380
Report Number2029214-2021-01028
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 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-300-14
Device Catalogue NumberPED2-300-14
Device Lot NumberA759625
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 Manufactured12/27/2018
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: 08/18/2021 Patient Sequence Number: 1
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