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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 PED2-325-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Vision (2139); Visual Disturbances (2140); Stenosis (2263); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 11/12/2021
Event Type  Injury  
Event Description
Medtronic received a report that a pipeline patient experienced stenosis or thrombosis of the side branch blood vessels or parent arteries covered by the flow diverter, blindness, visual/vision disorder, eye disorder, and deterioration of their mrs score. The patient was undergoing treatment for an unruptured, sacciform aneurysm located in the c5 segment of the right ica on the greater curvature side. The max diameter was 6. 4mm, the height was 4. 6mm, the dome diameter was 5. 3mm, and the neck diameter was 4. 0mm. There was no daughter sac.  antiplatelet treatment was administered without anticoagulant therapy.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that a pipeline patient experienced stenosis or thrombosis of the side branch blood vessels or parent arteries covered by the flow diverter, blindness, visual/vision disorder, eye disorder, and deterioration of their mrs score. The patient was undergoing treatment for an unruptured, sacciform aneurysm located in the c5 segment of the right ica on the greater curvature side. The max diameter was 6. 4mm, the height was 4. 6mm, the dome diameter was 5. 3mm, and the neck diameter was 4. 0mm. There was no daughter sac.  antiplatelet treatment was administered without anticoagulant therapy.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13206111
MDR Text Key286156395
Report Number2029214-2022-00020
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-325-16
Device Catalogue NumberPED2-325-16
Device Lot NumberB184247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/31/2021
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: 01/10/2022 Patient Sequence Number: 1
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