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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-500-30
Device Problems Retraction Problem (1536); Migration (4003)
Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. Per the instructions for use (ifu): do not place the pipeline flex embolization device with shield technology in patients whom a p re-existing stent is in place in the parent artery at the target aneurysm location. Caution: the presence of other indwelling endovascular stents may interfere with proper deployment and function of the pipeline flex embolization device with shield technology. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that two pipeline flex devices were deployed and then while removing the system, the ptfe sleeve of the pipeline device did not close and trap the microcatheter, causing the entire system to fall, and the devices to remain inside the aneurysm. Furthermore, two derivos devices were requested, where one was implanted in the distal part of the artery and the other in the proximal part. The pipelines were among the derivos in the final image. No patient injury was reported as a result of the procedure. The patient was undergoing embolization treatment of an unruptured fusiform aneurysm measuring 40mm x 25mm located in the basilar artery. The distal and proximal landing zone were 5mm x 5mm. The patient¿s vasculature was severe in tortuosity. The patient was on dual antiplatelet therapy.
 
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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
7635263305
MDR Report Key8421175
MDR Text Key138812875
Report Number2029214-2019-00201
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Model NumberPED-500-30
Device Lot NumberA532519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1
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