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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-425-20
Device Problems Break (1069); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
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 could not be opened in the middle third segment despite pulling, pushing, and resheathing maneuvers. They attempted to remove the flow diverter, but it was stuck inside the medtronic microcatheter so both the flow diverter and microcatheter were replaced with new devices to successfully complete the procedure. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 17mm with unknown neck size located in the paraclinoid/ophthalmic segment of the left internal carotid artery (ica). The distal and proximal landing zone diameters were unknown. The patient¿s vasculature was severe in tortuosity. The patient was on dual antiplatelet therapy, but pru levels were unknown. Post procedural angiography was satisfactory. The devices were prepared as indicated in the instructions for use (ifu).
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceLASER THERAPY PRODUCT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key9685691
MDR Text Key198870685
Report Number2029214-2020-00124
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/06/2021
Device Model NumberPED2-425-20
Device Catalogue NumberPED2-425-20
Device Lot NumberA736446
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2018
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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