• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-20
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2019
Event Type  malfunction  
Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description. The pipeline flex device the tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint). This condition was not reported at time of the event. The pipeline flex and medtronic catheter were returned for analysis. The pushwire coil tip was pushed outside of the catheter tip. Resistance was encountered when attempting to advance or retract the braid out of the micro catheter. The braid was pushed out the distal end. The pushwire was retracked out of the hub of the catheter. No damages or irregularities were found with the pipeline flex pushwire; however, the tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint). The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact. The distal and proximal braid sections did not fully open, and dried blood was found on the braid. The middle section of the braid was found fully opened. The distal wire was found stuck within the braid. The braid was put into cleaner to remove the dried blood. The proximal braid fully opened however the braid was found slightly tapered. The distal braid section fully opened; fraying and damages were observed with the braid tips. The pad assembly came off the distal wire due to the separation but was found intact. From the damages seen on the pipeline flex braid (frayed/damaged distal end) and pushwire (separation at solder joint); it appears there was high force used. It is likely these damages occurred when the customer attempted to advance and retract the pipeline flex through the marksman catheter against resistance. The end of the detached distal wire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis. The elemental analysis of the detached pushwire end showed presence of tin (sn). Separation can occur if excessive force is used exceeding the tensile strength of the material. Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning. As the analysis 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 information that during procedure, the pipeline couldn't be pushed out from marksman normally. Replaced with a new one and the procedure completed normally. The patient underwent embolization treatment for an aneurysm. The vessel tortuosity was normal. There were not any patient symptoms or complications associated with this event. No patient injury was reported. Reported device and any accessory devices were prepared as indicated in the ifu. The catheter flushed as indicated in the ifu. Evaluation of the returned device found that the pipeline flex pushwire, tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9862400
MDR Text Key190008397
Report Number2029214-2020-00270
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 03/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model NumberPED-425-20
Device Lot NumberA823551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-