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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-450-16
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device has been received and is pending evaluation. Once the evaluation is complete, 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 it was difficult to advance the flow diverter to the distal part of the microcatheter. They noticed buckling in the system at the microcatheter hub. The procedure needed to be aborted and the flow diverter became stuck inside the microcatheter. After the devices were removed from the patient, the physician attempted to remove the flow diverter and the delivery wire from the microcatheter but could not. The physician proceeded to pull on the delivery wire with the hemostats to unlock it from the microcatheter and the pushwire broke. A new medtronic flow diverter and medtronic microcatheter was used to complete the procedure. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of an unruptured amorphous aneurysm measuring 7mm x 6mm located in the supraclinoid segment of the right internal carotid artery (ica). This distal and proximal landing zone was 3. 00mm x 4. 00mm. The patient¿s vasculature was severe in tortuosity so use of the pipeline flex was against indications. The patient was on dual antiplatelet therapy. The pru level was 42. There are no images for review.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10222304
MDR Text Key199457025
Report Number2029214-2020-00646
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-16
Device Catalogue NumberPED-450-16
Device Lot NumberA894163
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/08/2019
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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