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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia (1942)
Event Date 04/19/2019
Event Type  Injury  
Manufacturer Narrative
The report is submitted at this time based on new information received about the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the patient experienced headaches with nausea on (b)(6) 2020. An mri performed on (b)(6) 2019 also showed an acute ischemic cerebrovascular accident in the left middle cerebral artery territory. Additional information received reported that the main sub- and supratentorial brain structures were visualized in a series of brain mr images in axial, saggital, and coronary views, in ¿1 and ¿2-weighted images. No shifting of midline structures was found. No dropsy. A discrete area has been identified of subcortical ischemic changes in the posterior sections of the right frontal lobe, spreading from the posterior sections of the sylvian fissure. It was concluded that there was an acute ischemic cerebrovascular accident in the left middle cerebral artery basin. The devices were prepared as indicated in the instructions for use (ifu). The patient was being treated for a saccular aneurysm located in the left ica c6. The aneurysm size of the first aneurysm treated was 13. 9mm, and the neck size was 9. 5mm. Additional information received reported the patient had undergone pipeline implantation of two pipeline devices, the first on (b)(6) 2019 and the second on (b)(6) 2019, to treat 3 aneurysms. On (b)(6) 2019, mri revealed acute ischemic cerebrovascular incident in the left middle cerebral artery. The event was not reported to be life threatening and there was no noted patient disability. However, it did result in prolonged hospitalization of the patient who was discharged on (b)(6) 2019. Assessment determined the event was unlikely due to the pipeline device(s) but had a causal relationship with the procedure. It was also noted that the event was probably related to the disease under study but not to any additional underlying patient disease or condition.
 
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Brand NamePIPELINE FLEX
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 Key11422668
MDR Text Key234986378
Report Number2029214-2021-00251
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberA755202
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 Received03/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2018
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: 03/05/2021 Patient Sequence Number: 1
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