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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-30
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device involved in the event has not been returned; therefore the event cause could not be determined. Correspondence has been sent out for return of the device. Once the device has been received and investigation completed. A supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the medtronic flow diverter pushwire fractured. Prior to the event, the medtronic microcatheter was placed in the m1 segment of the middle cerebral artery (mca) and then the flow diverter was pushed in the cavernous sinus and large resistance was felt. The flow diverter was finally able to reach the m1 segment, but the pushwire could only be pushed to the tip of the microcatheter and could not be pushed out any further. The entire system (flow diverter and microcatheter ) were withdrawn to the internal carotid artery (ica) and that was when the physician noticed that the pushwire had fractured and the flow diverter braid remained in the microcatheter when the whole part was withdrawn. The physician decided to terminate the treatment. The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 11. 69mm x 6. 35mm located in the ophthalmic segment of the left internal carotid artery (ica). The distal and proximal landing zone was 3. 45mm x 4. 48mm. The patient¿s vasculature was moderate in tortuosity. It was unknown if the patient was on dual antiplatelet therapy. There are no images for review.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9633376
MDR Text Key186775841
Report Number2029214-2020-00078
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-30
Device Lot NumberA844330
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 Received02/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2019
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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