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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 Problem Brain Injury (2219)
Event Date 09/26/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cherian, j. , srinivasan, v. , froehler, m. T. , grossberg, j. A. , cawley, c. M. , hanel, r. A. , puri, a. , dumont, t. , ducruet, a. F. , albuquerque, f. , arthur, a. , cheema, a. , spiotta, a. , anadani, m. , lopes, d. , saied, a. , kim, l. , kelly, c. M. , chen, p. R. , mocco, j. (2020). Flow diversion for treatment of intracranial aneurysms in pediatric patients: multicenter case series. Neurosurgery, 87(1), 53¿62. Doi:10. 1093/neuros/nyz380 medtronic received a literature article aiming to report technical, angiographic, and clinical outcomes in patients aged 21 or below undergoing flow-diversion treatment for intracranial aneurysms. The article included 39 patients undergoing 46 treatment sessions with pipeline embolization device placement between 2012 and 2018. A total of 50 intracranial aneurysms were treated. The study included a majority male patients. Nonsaccular morphology was seen in half of identified aneurysms. Six aneurysms were giant, and five patients were treated acutely after ruptured presentation. Complete aneurysm occlusion was seen in 74% of treated aneurysms. In the first case related death a (b)(6) yr-old boy presented with severe traumatic brain injury and polytrauma. Workup revealed diffuse subarachnoid hemorrhage with intraventricular extension and hydrocephalus. Noninvasive imaging identified a basilar artery dissect ion with an associated 2. 4mm distal basilar artery aneurysm. The patient underwent uncomplicated placement of a single ped with shield technology spanning the midbasilar to left p2. Despite initial recovery, the patient acutely declined on postprocedure day 19. Imaging revealed rerupture of the dissecting aneurysm with extensive subarachnoid and brainstem hemorrhage. The patient died shortly t hereafter. A in the second case related death a (b)(6) yr-old girl with a history of recurrent pituitary blastoma treated previously with resection, stereotactic radiosurgery, and chemotherapy, presented with headache, seizure, and left hemiparesis. Emergent imaging revealed subarachnoid hemorrhage and a 5mm right internal carotid artery terminus aneurysm. Interval imaging 2 weeks post procedure showed new intraventricular hemorrhage and aneurysmal recurrence. This recurrence was treated with additional coil embolization and pipeline placement. The operation was uncomplicated, and the patient woke at neurologic baseline. However, the patient declined suddenly the following day. Repeat head ct revealed extensive subarachnoid, intraparenchymal, and subdural hemorrhages. The patient ultimately died several days later. A third death occurred in a patient with microcephalic osteodysplastic primordial dwarfism type ii with multiple intracranial aneurysms.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11016902
MDR Text Key221707155
Report Number2029214-2020-01312
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
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 Received11/16/2020
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: 12/16/2020 Patient Sequence Number: 1
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