• 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 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 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-35
Device Problems Break (1069); Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex braid will not be returned for investigation was it remains in the patient; however, pushwire is expected to be returned. Upon receipt of the device a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that upon retrieval of the pipeline flex pushwires broke. The aneurysm was reported to be giant and in the vertebrobasilar junction. The max diameter was 34mm. The distal landing zone was 4. 1mm and the proximal was 4. 8mm. The anatomy was reported to have been severe in tortuosity. It was reported that post successful pipeline deployment, while retracting the pipeline pushwire, the pushwire met resistance and would not come completely out of the mid - proximal end of the medtronic catheter. The physician pulled hard on the proximal end of the pushwire and it broke off at the hub of the catheter. Removed the catheter with part of the pipeline pushwire still in the catheter at this point access was lost through the pipeline construct. The physician was successful to rewire the pipeline construct and advance non-medtronic guidewire distal to the aneurysm. Additional pipelines were implanted. The vertebral artery was very tortuous. The patient was successfully treated with 6 pipelines devices and 1 micro vascular plug (mvp) device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
7635263305
MDR Report Key8592626
MDR Text Key144565081
Report Number2029214-2019-00449
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/18/2020
Device Model NumberPED-475-35
Device Catalogue NumberPED-475-35
Device Lot NumberA477840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-