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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 PED2-300-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)
Event Date 06/02/2021
Event Type  Injury  
Event Description
Medtronic received a report that diagnostic imaging performed on (b)(6) 2021 showed life-threatening oedema around the aneurysm. Right temporal hemorrhagic transformation was also observed, and it was stated to probably be due to the medication rivaroxaban taken for atrial fibrillation since (b)(6) 2020. Aneurysm recanalization was also reported, but did not require any treatment. Unspecified treatment was provided for the oedema, and the event was not resolved. The site assessed the event as possibly related to the device, procedure, and underlying condition/disease under study. The patient was undergoing surgery for treatment of a saccular aneurysm of the middle cerebral artery (mca) bifurcation branch with a max diameter of 22 mm and a 7 mm neck diameter. Additional information received indicated the adverse events were not recovered/not resolved. No additional medical or surgical intervention was required.
 
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 Key12463821
MDR Text Key280549725
Report Number2029214-2021-01160
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/05/2021
Device Model NumberPED2-300-18
Device Catalogue NumberPED2-300-18
Device Lot NumberA656442
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 Received09/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/06/2018
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: 09/13/2021 Patient Sequence Number: 1
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