• 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 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 W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-25
Device Problems Positioning Failure (1158); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
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 distal part of the pipeline failed to open. The patient was undergoing treatment for an unruptured, primarily saccular aneurysm with a fusiform neck component located in the right cavernous ica. The max diameter was 15. 5mm, and the neck diameter was 6. 5mm. The patient's vessel tortuosity was severe. The landing zone was 3. 8mm distal and 4. 2mm proximal. Dual antiplatelet treatment was administered, and the act value was 197. It was reported that difficulty was noted as the pipeline passed through the cervical segment due to the patient's anatomy. The distal part of the pipeline was observed to have lazy opening, and the physician questioned whether the stent was twisted as it appeared to show difficulty opening on the anterior x-ray. Angiographic imaging was unable to confirm twisting of the stent; however, due to the confirmation of lateral x-ray plane not showing a ribboning effect, a note was made that the anatomy was extremely tortuous and had multiple turns in multiple directions. It was noted that 3d imaging available could suggest a vascular anomaly that could have been causing the pipeline to appear as though it was not opening all the way. Two resheathing attempts and minor adjustments in the landing zone were made, but neither resolved the visualization of the pipeline. The physician decided to remove the pipeline, and a new device was successfully placed. It was noted that the distal end of the pipeline was placed in a bend, and no other steps were taken to open the device. More than 50% had been deployed when it failed to open.  the patient did not experience any injury or complications. Angiographic results post procedure showed successful placement of the pipeline with no vascular abnormalities. The devices were flushed and prepared according to the instructions for use (ifu). Ancillary devices include a penumbra bmx sheath, phenom plus guide catheter, synchro 14 guidewire, phenom 27 microcatheter, axium frame coils, stryker xl coils, echelon 10 catheter, and stryker transform balloons.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key12538362
MDR Text Key273588385
Report Number2029214-2021-01211
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-25
Device Catalogue NumberPED2-450-25
Device Lot NumberB193956
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 Received09/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-