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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-021-250-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Stenosis (2263)
Event Date 10/06/2021
Event Type  Injury  
Manufacturer Narrative
Only patient's year of birth was reported, not the patient's full birthdate. Therefore, only the reported year (b)(6) is valid. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a patient who presented on (b)(6) 2021 with acute infarctions of the left caudette and lentiform nuclei. Thinned m1 and m2 segments of the left middle cerebral artery (mca) were observed and non-visualized anterior cerebral artery (aca). The patient was hospitalized and discharged the following day,()(6) 2021. The event was not considered life threatening and did not result in further treatment or intervention though diagnostics labs were completed. The patient had undergoing flow diversion treatment of a left mca saccular aneurysm on (b)(6) 2021. Aneurysm max diameter was 6mm and neck measured 4. 6mm. There were no reported intra-operative issues or device malfunctions. Medtronic assessment determined the event was possibly study device and procedure related.
 
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Brand NamePIPELINE VANTAGE WITH 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 Key12661037
MDR Text Key277399113
Report Number2029214-2021-01305
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED3-021-250-14
Device Catalogue NumberPED3-021-250-14
Device Lot NumberB180980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/25/2021
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: 10/19/2021 Patient Sequence Number: 1
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