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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Type  Injury  
Manufacturer Narrative
Citation: world neurosurgery, pervinder bhogal, oliver ganslandt, hansjo¨ rg bazner et. Al. The fate of side branches covered by flow diverters results from 140 patients the purpose of this article is flow diverter stents (fds) are a recognized treatment option for intracranial aneurysms. There remain ongoing concerns regarding the safety of fds, especially regarding the fate of covered side branches. This article reports the patency of side branches covered by fds. The article identified 140 patients, with 147 aneurysms, the mean average age was 56. 2 +/- 13. 7 years, male patient 31(21. 9%). The devices will not be returned for evaluation as they remain implanted; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, there is no evidence suggesting that the device was defective, but rather a patient's condition. Additional information has been requested from the author of this article regarding this case. Should it become available a supplemental report will be submitted. Related mdrs for this event: 2029214-2017-00885 2029214-2017-00886.
 
Event Description
Medtronic received information through literature review that approximately 18 months after implanting 2 pipeline embolization devices (peds) to treat an incidental achoa aneurysm, the patient was advised to stop clopidogrel and there were no complications. However, 1 year later, the patient discontinued aspirin and reported vague visual symptoms. Angiography showed minor thrombi adherent to the posterior-inferior wall of the ped. Mri performed on the same day showed multiple restricted diffusion deficits consistent with emboli. The patient was immediately restarted on aspirin and prasurgrel. Repeat angiogram 1 week later showed resolution of the thrombus. The patient was asymptomatic (mrs score, 0).
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6703162
MDR Text Key79732760
Report Number2029214-2017-00886
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberNOT REPORTED
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 Received06/13/2017
Was Device Evaluated by Manufacturer? No
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: 07/11/2017 Patient Sequence Number: 1
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