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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
Device Problems Activation, Positioning or SeparationProblem (2906); Migration (4003)
Patient Problems Death (1802); Hydrocephalus (3272)
Event Type  Death  
Manufacturer Narrative
However, since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Interv neuroradiol. 2019 aug;25(4):407-413. Doi: 10. 1177/1591019918824003. Epub 2019 feb 25. ¿treatment of posterior inferior cerebellar artery aneurysms using flow-diverter stents: a single-center experience¿ su¨kru¨ og¿uz and hasan dinc. Medtronic received the following report through literature review: eight patients with eight aneurysms related to the pica were treated with a flow-diverter stent between september 2013 and may 2017. Half of the patients were female, and the mean age was 55 years (range, 34 to 71). Procedural success was 100% (8/8), and there were no ischemic complications. In two cases the proximal part of the stent shortened and migrated. Case #3: in one patient, we deployed a second stent telescopically. This patient presented with sah and was treated in the acute period but died because of rebleeding two weeks after the procedure (mrs, 6). Case #4: a (b)(6)-year-old male patient who had a right vertebral artery v4 segment incidental fusiform aneurysm. Digital subtraction angiography (dsa) image demonstrating a right vertebral artery v4 segment fusiform aneurysm involving the right posterior inferior cerebellar artery (pica) origin. The road-map image shows that the stent was dropped into the aneurysm sac, which passed near the stent. Fluoroscopic, dsa and dyna computed tomography images showing the final state; the second stent and the first stent were jailed in the aneurysm. (f) at the six-month follow-up dsa, the aneurysm was totally occluded, and the pica was patent. Four patients presented with sah, and three of them (case nos. 2, 3 and 8) developed impairment of consciousness secondary to acute hydrocephalus. Lumbar drainage was performed at regular intervals considering the changes in the patient¿s state of consciousness. Hydrocephalus did not persist in the chronic period in any patient, and external ventricular drainage was not necessary. Other than case #3, all the patient mrs scores were zero at discharge and at the clinical follow-up period.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9848715
MDR Text Key183930609
Report Number2029214-2020-00252
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received03/05/2020
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: 03/18/2020 Patient Sequence Number: 1
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