• 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-325-20
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pipeline flex device stuck inside the medtronic catheter and distal part of the pushwire along with the pipeline got detached inside the catheter during removal. The patient was undergoing embolization treatment for a flow diversion of a small unruptured 2 blister aneurysm located in internal carotid artery (ica) bifurcation and middle cerebral artery (mca). Measuring 2. 5 mm x 2. 5mm, 2mm x 1. 5mm, neck diameter (mm) 2. 5mm, 1. 5mm. Landing zone distal 3mm proximal 3. 27mm. The vessel was observed severely tortuous. It was reported that left ica was accessed with guide sheath and medtronic distal access catheter. There was an acute bend in the cavernous segment and this was not an issue to take medtronic catheter and non-medtronic guidewire across and beyond aneurysm and to the distal landing zone. When pipeline flex device was tried to navigate to its target position, the physician felt hard to navigate beyond terminal ica. It was observed the device getting twisted and the physician decided not to proceed further and removed the device. While removing he observed the pipeline flex had got detached in the catheter itself. Another pipeline device and another medtronic catheter was used and completed the procedure successfully. The angiographic result post procedure shows stasis after second device deployed. There were no reports of patient injury in association with this event.
 
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
7635263305
MDR Report Key8809906
MDR Text Key153123648
Report Number2029214-2019-00763
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCE
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 10/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-325-20
Device Lot NumberA395077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
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

-
-