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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-475-20
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report if pipeline flex incomplete opening during a procedure. The patient was undergiong treatment of an unruptured, saccular aneurysm in the cavernous internal carotid artery (ica. ) vessel tortuosity was described as severe. The devices were prepared as indicated in the ifu. A continuous flush was maintained. During the procedure, the cook shuttle and neuro microcatheter was advanced to the desired location, then the marksman was navigated to the m1 middle cerebral artery (mca). The pipeline flex was advanced smoothly until the distal marker coincided with the marksman distal marker. The ped was opened 5mm in straight segment. Post opening of distal end of the stent, the whole device was pulled to the landing zone from where the deployment need to be started. The device opened well at the distal end but had difficulty opening it in mid segment. It was reported that maneuvering was attempted, the device was resheathed twice and re-deployed; the device would not open in the mid-segment. The ped and marksman were removed. The device was replaced with other manufacturer's device to continue the procedure. There were no reports of patient injury.
 
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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 Key9526710
MDR Text Key198551254
Report Number2029214-2019-01302
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 03/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2021
Device Model NumberPED-475-20
Device Lot NumberA725751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2018
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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