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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); Intracranial Hemorrhage (1891); Vasoconstriction (2126); Thromboembolism (2654)
Event Date 11/04/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Almatter m, aguilar pérez m, hellstern v, et al. Flow diversion for treatment of acutely ruptured intracranial aneurysms: a single center experience from 45 consecutive cases. Clinical neuroradiology. 2020;30(4):835-842. Doi:10. 1007/s00062-019-00846-5. Medtronic literature review found a report of patient complications in association with a pipeline procedure. The purpose of this article was to review complication rates and clinical and radiologic outcomes for the use of flow diverter stents (fds) in the acute setting of subarachnoid hemorrhage (sah). In this study 45 patients (48. 9% females; mean age 58. 8± 12. 4 years) were included. Nine of the patient¿s were implanted with a pipeline embolization device, and the rest used a phenox p64 flow modulation device. The clinical condition on presentation was good (hunt and hess, hh i¿ii), moderate (hh iii) and poor (hh iv¿v) in 21 (46. 7%), 13 (28. 9%), and 11 (24. 4%) patients, respectively. The ruptured aneurysms were saccular, blister-like, fusiform and dissecting in 18 (40%), 5 (11. 1%), 7 (15. 6%), and 15 (33. 3%) cases, respectively. Of the aneurysms 22 (48. 9%) were in the posterior circulation (45% of which were at the basilar artery) and of these 18 (81. 8%) were non-saccular. The mean size of the saccular aneurysms was 6. 1± 5. 3mm (2¿25mm), all with a dome to neck ratio <(><<)>1. 5. The article does not state any technical issues during use of the pipeline device. The following intra- or post-procedural outcomes were noted: intraprocedural rebleeding from the dissected right v4 segment occurred in one case before catheterization and resulted in massive and fatal raise of the intracranial pressure despite the already inserted external ventricle drainage (evd). - in one case, a combination of stent thrombosis and refractory cerebral vasospasm (cvs) resulted in fatal middle cerebral artery (mca) infarction. Intraprocedural thrombus formation in or in the vicinity of the device(s) was observed in two cases (4. 4%) and both resolved after an intravenous bolus of eptifibatide with no resultant ischemia. - in one case, incompliance with the dapt resulted in asymptomatic stent thrombosis, which was discovered on a routine angiographic follow-up. Minor hemorrhage along the evd tract was noticed on cross-sectional imaging in 3 (13%) cases. There were, however, no records of major hemorrhagic complications requiring surgical intervention. Reduced filling and unchanged filling of the aneurysm were observed in 29 (64. 4%), and 10 (22. 2%) cases, respectively.
 
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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 Key11616320
MDR Text Key243847207
Report Number2029214-2021-00396
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
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 Received03/15/2021
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: 04/05/2021 Patient Sequence Number: 1
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