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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
Model Number NV UNK PIPELINE
Device Problem No Apparent Adverse Event (3189)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891)
Event Type  Death  
Manufacturer Narrative
See related regulatory report 2029214-2020-00267. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Griffin a, reese v, hüseyinoglu z, et al. Predictors of clinical outcome after treatment of intracranial aneurysms with the pipeline embolization device.  world neurosurgery. 2019;130: e666-e671. Doi: 10. 1016/j. Wneu. 2019. 06. 185. Medtronic received a literature article pertaining to a study to identify predictors of adverse events associated with the pipeline. In this study the mean age was 56. 3, 80% female. The study took place between january 2014 and september 2018. 204 aneurysms in 170 patients were treated with the pipeline. 181 aneurysms were located in the anterior circulation, and 23 were found in the posterior circulation. 82% of aneurysms were saccular, followed by 11% fusiform and 4% blister. (11%). The mean aneurysm size was 8. 2mm. The neurologic mortality rate was 1. 8%, occurring in 3 patients, with deaths due to stroke, iph, or aneurysm rupture. The all-cause mortality was 2. 9%, occurring in 5 patients.
 
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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 Key9860861
MDR Text Key184303782
Report Number2029214-2020-00268
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
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 Received03/09/2020
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: 03/20/2020 Patient Sequence Number: 1
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