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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Stenosis (2263)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kühn, a. L. , kan, p. , henninger, n. , srinivasan, v. , rodrigues, k. D. M. , wakhloo, a. K. , ¿ puri, a. S. (2019). Impact of age on cerebral aneurysm occlusion after flow diversion. Journal of clinical neuroscience, 65, 23¿27. Doi: 10. 1016/j. Jocn. 2019. 04. 024. Medtronic literature review found reports of patient complications after pipeline implantation. The purpose of this article was to evaluate the safety and efficacy of the pipeline (ped) in different patient age groups with unruptured intracranial aneurysms. The authors reviewed the results of 260 patients: 52 patients in the young age group, 144 middle age, 64 in the older age group. Male-to-female ratio was 1:6. The article notes the following outcomes: - 35 patients experienced mild to severe intimal hyperplasia - 3 patients experienced intraparenchymal hemorrhage.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9927101
MDR Text Key193404868
Report Number2029214-2020-00332
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2020
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 Received03/10/2020
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: 04/05/2020 Patient Sequence Number: 1
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