• 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-450-25
Device Problems Break (1069); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
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 the pipeline failed to open in the middle section and was damaged. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ophthalmic artery segment. The max di ameter was 7mm, and the neck diameter was 6mm. The patient's vessel tortuosity was severe. The landing zone was 4mm distal and 4. 5mm proximal. The access vessel was the femoral artery. It was reported that after the microcatheter was in place and the doctor started to deliver the pipeline it was found that the stent was kinked at the horizontal section of c4, and the anterior and posterior sites could be opened. The kink and flattened horizontal section of the stent could not be resolved by pushing and pulling the stent several times. The pipeline was repeatedly retrieved and repositioned to the distal side. After more than two resheathing attempts, it was still kinked at the c4 horizontal segment and could not be deployed normally. It was noted that there were burrs on the tip of the pipeline, so the entire pipeline and microcatheter delivery system were withdrawn. The pipeline was not positioned in a bend when the middle section failed to open, and more than 50% had been deployed at the time. After the whole set was withdrawn from the body, the assistant pulled the pipeline pushwire from the proximal end of the microcatheter so that the pipeline and developing wire at the distal end of the pushwire remained in the micro catheter. In order to remove the stent, the distal end of the microcatheter was cut, but the device was not found. Posterior fluoroscopy revealed that the stent was located in the proximal hub section of the microcatheter. The hub section of the microcatheter was removed to take out the pipeline, and the distal end of the stent was found to be rough. The device was replaced. And the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a phenom 27 microcatheter.
 
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12313350
MDR Text Key266223014
Report Number2029214-2021-01011
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,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberB077662
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 Received08/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-