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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-425-16
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2020
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. The pipeline flex pushwire was returned outside the medtronic catheter. The pushwire was found to be separated/broken proximal to the dps sleeves. The tip coil and dps sleeves were not returned for analysis and the reason was not provided. No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper. The hypotube was found to be stretched. No bend or kink were observed on the pushwire. The catheter was then tested by running an in-house mandrel through catheter tip and hub to remove the braid. The mandrel successfully passed through the catheter hub and tip without any resistance and the braid pushed out from the catheter with no issues. The distal and proximal ends of the pipeline flex braid were found opened and moderately frayed. The pushwire broken segment sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analysis. Per the sem result features observed indicate the wire failed via torsional overload failure mechanism. From the damages seen on the catheter body (kinking), pipeline flex braid (fraying) and hypotube (stretching); it is likely high force used during the delivery. It is likely that the patient tortuous anatomy may have contributed to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pipeline flex stuck (locked up) in catheter or resistance in medtronic catheter. It was reported that heavy resistance in insertions of pipeline into the catheter immediately felt heavy resistance. The catheter flushed continuously with heparanized saline. Reported device and any accessory devices were prepared as indicated in the ifu. Removed and replaced the both devices. Once devices replaced new pipeline and medtroinc worked without issue. The patient was being treated for a 5mm aneurysm of the left internal carotid artery. The vessel tortuosity was moderate, there were no patient symptoms, complications, or involvement. 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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10350834
MDR Text Key202378367
Report Number2029214-2020-00759
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536016149
UDI-Public00847536016149
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 08/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/07/2021
Device Model NumberPED-425-16
Device Catalogue NumberPED-425-16
Device Lot NumberA704308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2018
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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