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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-450-40
Device Problems Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)
Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that at the 6 month follow-up appointment after a pipeline stent (model: ped3-027-450-40, lot: a942457) was implanted, dsa noted "endoleak and stretchingof the left ica pipeline¿. The patient was asymptomatic and no additional medical interventions were performed. The patient had been treated with flow diversion for an unruptured saccular aneurysm of the c5. The aneurysm max diameter was 5. 3mm and the neck diameter was 1. 3mm. Vessel tortuosity was minimal. Dual antiplatelet treatment (dapt) was administered with pru level of 94. Post-operative angiography revealed raymond and royal class 3 - residual aneurysm with complete aneurysm neck coverage of a minimum of 3mm at each side of the aneurysm neck. Additional information received reported that 180 day follow-up imaging to the core lab did not note ¿endoleak or stretching,¿ however they did note the in-stent stenosis, device flattening, and incomplete wall apposition. The target intracranial unruptured saccular aneurysm was located at the left internal carotid artery segment (c5) measuring 5. 3x4. 0mm with dome-to-neck ratio 1. 3.
 
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Brand NamePIPELINE VANTAGE WITH SHIELD TECHNOLOGY
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 Key11070165
MDR Text Key225564894
Report Number2029214-2020-01366
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,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-40
Device Catalogue NumberPED3-027-450-40
Device Lot NumberA942457
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 Received02/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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