• 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 W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

  • 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 W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-250-16
Device Problem Break (1069)
Patient Problems Paresis (1998); Device Embedded In Tissue or Plaque (3165)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that pipeline pushwire broke and the patient experienced paresis. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the anterior communicating (acom) artery with a max diameter of 2mm and a 2mm neck diameter. It was reported that all devices were prepared per the instructions for use (ifu), and the pipeline was implanted successfully. During retrieval, the distal segment of the pushwire broke, and the flaps blocked the artery. The physician tried to withdraw the broken segment using a solitaire, but was unsuccessful. The artery was unblocked by pushing the tip of the guide to the most distal portion, but the broken segment of the pushwire was left in the left cerebral artery - a2. The remainder of the pipeline pushwire was discarded. The patient experienced paresis on the right side and remained under observation in intensive care. Post-procedure angiographic results showed revascularization and the tip coil stayed on the patient's head. Ancillary devices include a xt 27 - stryker microcatheter, synchro 0 ,014" guidewire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceLASER THERAPY PRODUCT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10360413
MDR Text Key202779006
Report Number2029214-2020-00765
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-250-16
Device Catalogue NumberPED2-250-16
Device Lot NumberA830768
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-