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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 PED2-450-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Type  Injury  
Event Description
Medtronic received a report that a patient had 3 strokes after having a pipeline device implanted.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIPELINE FLEX W/SHIELD TECHNOLOGY
Type of Device
INTRACRANIAL 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 Key14174341
MDR Text Key293631225
Report Number2029214-2022-00690
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284503
UDI-Public00763000284503
Combination Product (y/n)N
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPED2-450-12
Device Catalogue NumberPED2-450-12
Device Lot NumberB311851
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/11/2022
Initial Date FDA Received04/21/2022
Date Device Manufactured12/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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