• 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 PED2-400-12
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline device that failed to open and became stuck within the phenom-27 microcatheter during retrieval. The patient was being treated for an unruptured wide-necked fusiform aneurysm of the right internal carotid artery below the posterior communicating segment. The aneurysm neck diameter was 3 mm. The distal landing zone was 3. 11 mm and the proximal landing zone was 4. 07 mm. Vessel tortuosity was normal. Dual antiplatelet treatment (dapt) was administered with pru level 27 which was noted to be normal. It was reported that all devices were prepared as indicated in the instructions for use (ifu). The pipeline failed to open along the entire device. The pipeline was positioned in a vessel bend. The pipeline was unsheathed in a straight vessel segment to ensure the ptfe/protective sleeves did not cover the tip of the pipeline. The physician then attempted simultaneous pull and unsheath, attempted drag-and-drop technique, unsheathed and resheathed, try to push the device with a wire or catheter to encourage opening, left in place to allow time, but the pipeline would not open. During resheathing and retrieval of the pipeline, it became stuck in the middle section of the phenom-27 microcatheter. The physician attempt to release the slack in the system but this did not resolve the issue. The catheter was flushed continuously with heparinized saline during the procedure. No damage was observed to the phenom catheter but there was damage to the distal end of the pipeline pushwire. More than 50% of the pipeline had been deployed when it failed to open. The pipeline was resheathed more than two times. The pipeline and phenom catheter were removed together and were replaced to complete the procedure. There was no harm or injury to the patient. The patient did not experience any related symptoms. Ancillary device: navien 058 155cm intracranial support catheter.
 
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 Key10951197
MDR Text Key219883034
Report Number2029214-2020-01236
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSZ
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2021
Device Model NumberPED2-400-12
Device Catalogue NumberPED2-400-12
Device Lot NumberA729556
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-