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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Neurogenic Shock (2265)
Event Date 01/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Fujii, t. , oishi, h. , teranishi, k. , yatomi, k. , suzuki, k. , & arai, h. (2020). Outcome of flow diverter placement for intracranial aneurysm with dual antiplatelet therapy and oral anticoagulant therapy.  interventional neuroradiology, 26(5), 532¿538. Https:/ /doi. Org/10. 1177/1591019920947878. This retrospective study evaluated the complications and obliteration rates after flow diverter placement in patients taking anticoagulants. A total of 155 cases were treated by pipeline flex placement for unruptured large and giant cerebral aneurysms in our hospital between october 2015 and june 2019. The groups of 8 patients taking anticoagulants before operation and 147 patients not taking anticoagulants were compared. Additional coiling was performed in one patient in the anticoagulant group, and 46 patients in the nonanticoagulant group. Distal p arenchymal hemorrhage was observed in no patients in the anticoagulant group, and 5 patients in the non-anticoagulant group. Symptomatic ischemic complications were observed in no patients in the anticoagulant group, and 9 patients in the non-anticoagulant group. Delayed aneurysm rupture was observed in 2 patients in the anticoagulant group, but none in the nonanticoagulant group. Additional treatment was given to 3 patients in the anticoagulant group, and 7 patients in the non-anticoagulant group. Postoperative worsening of neurological symptoms was observed in 2 patients in the anticoagulant group, and 6 patients in the nonanticoagulant group. At the time of the final follow up, incomplete obliteration was found in 6 patients in the anticoagulant group, and 40 patients in the non-anticoagulant group. No procedure-related deaths occurred in this study.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key10999331
MDR Text Key221226210
Report Number2029214-2020-01289
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
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: 12/13/2020 Patient Sequence Number: 1
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