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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Ischemia (1942)
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. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Ajnr am j neuroradiol. 2019 mar;40(3):524-530. Doi: 10. 3174/ajnr. A5973. Epub 2019 feb 7. ¿comparison of pipeline embolization device sizing based on conventional 2d measurements and virtual simulation using the sim & size software: an agreement study¿ x j. M. Ospel, x g. Gascou, x v. Costalat, x l. Piergallini, x k. A. Blackham, and x d. W. Zumofen seventy-four consecutive patients from 2 tertiary neurovascular centers were included. Center a contributed 63 patients (85. 1%), and center b contributed the remaining 11 patients (14. 9%). While the mean age distribution between the 2 centers was not different (overall: 58. 6 _ 13. 3 years; center a: 58. 6 _ 14. 0 years; center b: 58. 5 _ 8. 6 years). Ischemia in the same territory as pipeline (ped) deployment (4), and hemorrhage in the same territory as the ped deployment (2).
 
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Brand NamePIPELINE
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 Key9850586
MDR Text Key192055085
Report Number2029214-2020-00255
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,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/05/2020
Was Device Evaluated by Manufacturer? No
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: 03/18/2020 Patient Sequence Number: 1
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