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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hydrocephalus (3272)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. Neurological deterioration is a inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following report: site reported hydrocephalus post procedure. The adverse event onset date is (b)(6) 2018, the patient presented with confusion and dysartria, the ct showed hydrocephalus, the neurosurgeon decided for extracranial ventricular derivation. The ae resolved on (b)(6) 2018. The pseudoaneurysm was in the right vertebral artery. The max diameter was 5 mm, dome height 4 mm, dome width 5 mm, neck size 2. 8 mm, distal landing zone was 2. 5 mm and the proximal was 3 mm.
 
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Brand NamePIPELINE FLEX
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9744989
MDR Text Key180637932
Report Number2029214-2020-00161
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/27/2019
Device Model NumberPED-375-18
Device Lot NumberA394074
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 Received02/14/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/27/2016
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: 02/24/2020 Patient Sequence Number: 1
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