• 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-425-18
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Perforation (2001)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline flex device has not been returned; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. Mdrs related to this event: 2029214-2019-00487. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report of vessel perforation and extravasation. This event was reported to have occurred during pushing of the delivery wire to advance pipeline in a phenom microcatheter. The vessel was extremely tortuous, and it was difficult to advance. System then suddenly moved forward and caused perforation of m5 vessel. Other details will not be provided due to confidentiality reasons. There was also report of device locked up within the catheter. However, the pipeline was not stuck. The catheter was reported to have been damaged (unknown location). The pipeline and the accessory devices were prepared as indicated in the instructions for use (ifu). The catheter was flushed continuously with heparinized saline. The patient was on dual antiplatelet treatment (dapt). The patient was being treated for right an ophthalmic internal carotid artery (ica). The aneurysm was unruptured and saccular.
 
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 Key8646542
MDR Text Key146252345
Report Number2029214-2019-00486
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
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 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/13/2020
Device Model NumberPED-425-18
Device Lot NumberA413907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/28/2019 Patient Sequence Number: 1
-
-