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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK FLEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that a ct scan showed that the patient had unchanged extensive right frontoparietal craniectomy, herniation of the brain through surgical defect. The left frontal ventriculostomy catheter tip remained in the region of the third ventricle and significantly decreased ventriculomegaly. There was also a new large right frontotemporal convexity and interhemispheric right tentorial acute subdural hemmorage measuring 2. 4cm in thickness along the temporal convexity, 3. 0cm along the right frontal convexity, and 1. 5cm along the interhemispheric fissure. There was no significant change in large left frontotemporoparietal convexity acute subdural hemorrhage which measures 1. 8cm in maximal thickness. The underlying extensive intraparenchymal periventricular, subcortical lucencies remain unchanged compared to before procedure. The patient also had mild sinonasal mucoperiosteal thickening, and near complete opacification of mastoid and middle ear cavities.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10959156
MDR Text Key219899425
Report Number2029214-2020-01242
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
Device Lot NumberUNKNOWN
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 Received12/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/07/2020 Patient Sequence Number: 1
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