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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 PED2-350-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Vision (2139); Stenosis (2263); Thrombosis/Thrombus (4440)
Event Date 02/25/2022
Event Type  Injury  
Event Description
Medtronic received a report that the patient had a worsening of mrs score, pre-procedure/post-procedure was 0 and 30 days post-procedure was 1. The event required antiplatelet therapy. In addition, the patient had stenosis or thrombosis in the side branch vessels or parent arteries covered by the flow divider. The patient had blindness, visual impairment, eye damage. The patient was recovering at the time of the report. The patient was undergoing surgery for treatment of an unruptured aneurysm in the ica with a max diameter of 4. 3mm and a 3. 6mm neck diameter.
 
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 Key13662397
MDR Text Key286918884
Report Number2029214-2022-00341
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-350-30
Device Catalogue NumberPED2-350-30
Device Lot NumberB057438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/21/2020
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: 03/03/2022 Patient Sequence Number: 1
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