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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-400-20
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation. There was no pipeline flex braid returned with the pushwire. The pipeline flex pushwire was found outside of the phenom 27 catheter. The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. The ends of the detached pushwire were sent out for sem/eds analysis. Based on the analysis findings and sem/eds analyses, the pipeline flex was confirmed to have "pushwire detached at hypotube proximal to the wire weld". A review of the manufacturing process and lot history record did not uncover any deficiencies. In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline flex distal tip of the delivery system separated. The device separation occurred after deployment of the device and during recapture of the delivery wire. The separation occurred within the catheter. The device tip and the devilry system will be returned for analysis. There was no patient impact as a result of this event. The vessel anatomy was moderate. This event occurred in the left vertebral. A continuous flushed was used during the case. The devices were prepared and used per the instructions for use (ifu). Resistance was felt when the delivery wire was retrieved.
 
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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 Key9836907
MDR Text Key184451570
Report Number2029214-2020-00236
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 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberA837027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/24/2019
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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