• 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 PED2-400-20
Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that during a procedure, two pipeline shield devices had difficulty opening and with positioning. The patient was undergoing a procedure for flow diversion treatment of a ruptured blister aneurysm of the left internal carotid artery (ica) distal supraclinoid. The aneurysm max diameter was 1. 6mm and the neck diameter was 1. 6mm. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered. It was reported that due to the severe tortuosity of the ica, the guide catheter was parked at the ica origin. The navien 5f intracranial support catheter was tracked over the phenom 27 microcatheter to the supraclinoid syphon. At the supraclinoid level, a tight double bend in the vessel was present. The phenom microcatheter was parked at the m2 superior branch and the ped2-400-20 was loaded. The pipeline began opening well at the m1. The physician pulled it back below the terminal ica and the pipeline anchored very well. However, after 8-10mm of the device was deployed, the middle and proximal segment of pipeline were positioned in the bend and did not open and was moving independently in the opposite direction of the catheter. The physician attempted to resheath and redeploy twice but could not resolve the issue or fully resheath, even with attempt to use the navien. The ped2-400-20 was able to be half resheathed and was removed successfully from the patient's body. Once removed, the pipeline still could not be opened on the table. A ped2-400-18 was then introduced and deployment was attempted from the mid m1 to the proximal ica. This pipeline also opened well at the distal end but failed to open at the distal supraclinoid. Tried resheathing 3 times without resolving the issue. The physician deceived to remove the pipeline and end the procedure but while withdrawing the device, the physician was unaware the pipeline had be deployed from the phenom beyond the resheathing marker and the device proximal end opened in the navien. The pipeline was half deployed in the patient's ica proximal to the aneurysm and half deployed in the navien. Attempts to recapture the pipeline with a snare were unsuccessful to it was implanted, fully open, in the patient's ica without coverage of the aneurysm. The case was then abandoned. It was noted there was moderate friction with the pipelines and the phenom catheter during the procedure. The pushwire was not rota ted or pulled back at any time. All devices were prepared and the catheter flushed as indicated in the instructions for use (ifu). There were no patient symptoms or complication associated with the event. Post-procedure angiography results showed the ped2-400-18 fully open proximal to the aneurysm.
 
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 Key12233479
MDR Text Key264151000
Report Number2029214-2021-00935
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-20
Device Catalogue NumberPED2-400-20
Device Lot NumberB037650
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 Received07/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-