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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problems Break (1069); Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Fei liang, yupeng zhang, feng guo, yuxiang zhang, peng yan, shikai liang, yuhua jiang, peng jiang, chuhan jiang. (2018). Pipeline embolization device for posterior circulation aneurysms: single-center experiences with comparison with anterior circulation aneurysms, 112. Doi: 10. 1016/j. Wneu. 2018. 01. 129 medtronic literature review found a report of patient complications after pipeline implantation. The purpose of the article was to evaluate the performance of the pipeline embolization device (ped) for posterior circulation aneurysms. The authors retrospectively reviewed the results of 35 patients with 38 posterior circulation aneurysms who underwent treatment with the ped and compared them to 163 anterior circulation aneurysms. The article describes the following posterior circulation aneurysm events: - 1 patient encountered ped foreshortening. The article describes the following anterior circulation aneurysm events: -16 patients encountered malposition. - 3 patients encountered ped migration. - 3 patients encountered ped foreshortening. - 1 patient had the delivery wire fracture during the procedure.
 
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Brand NamePIPELINE 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 Key9167938
MDR Text Key168453320
Report Number2029214-2019-00999
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S004
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 10/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-REP
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 Received09/19/2019
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

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