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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-375-35
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2019
Event Type  malfunction  
Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description. The pipeline flex device pushwire found broken. This condition was not reported at time of the event. As received, the pipeline flex braid was found within the medtronic catheter hub. The pipeline flex braid appears to be stuck inside the catheter hub. In order to remove the braid from the hub, the catheter was cut, and the braid was then able to be removed. The proximal end of the pipeline flex braid was found fully open but frayed. The distal end of the pipeline flex braid was found constrained by the dps sleeves. The dps sleeves were removed from the distal end of the braid. The dps sleeves were found intact but damaged. The proximal dps restraint was found within the braid. The tip coil and distal dps restraints were found to be missing. The ends of the broken pushwire were sent out for sem (scanning electron micrographic) analysis. Per the sem analysis report, no original fracture features were available to determine failure mode. Therefore, no definitive conclusions can be provided. Based on the investigation conducted, use condition such as excessive force and patient vessel tortuosity can contribute to the event. Separation can occur if excessive force is used exceeding the tensile strength of the material. From the damages seen on the pipeline delivery system tip coil (missing) and pusher (broken); it appears there was high force used. It is likely these damages occurred when the customer attempted to advance the pipeline flex through the catheter against resistance. However, the cause of the event could not be determined. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the pipeline flex encountered resistance when advanced within the proximal and middle section of the medtronic catheter. This event occurred during advancement in the supraclinoid region after taking a big curve. New flow diverter was used to treat the patient. No patient injury occurred. The vessel anatomy was normal in tortuosity. Evaluation of the returned device found that the pipeline flex device pushwire found broken.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9459725
MDR Text Key206799626
Report Number2029214-2019-01221
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-35
Device Lot NumberA712071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
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

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