• 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 PED2-500-30
Device Problems Break (1069); Activation, Positioning or SeparationProblem (2906); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the tip of the pipeline flex with shield technology did not open after it was deployed, and the distal wire disconnected from the pushwire. Re-sheathing was done more than 3 times to attempt to open and deploy it but without success. The pipeline flex with shield technology was also noted to be shortened. The device was removed with snare / collection equipment and replaced by a medtronic product to complete the procedure. It was reported there were difficulties deploying in the distal region of the pipeline flex with shield technology. The pipeline flex with shield technology was deployed less than 50%. In an attempt to deploy the pipeline flex with shield technology, the physician pushed the device with more strength against resistance. Ancillary devices: chikai 14 guidewire, phenom 27 microcatheter, navien 5fr guide catheter, shuttle 6fr sheath follow up response received with the following information: friction was not noticed during delivery or positioning. The pipeline did not jump. Multiple pipelines were not used. The tip of the microcatheter was not under stress. It was reported that the microcatheter dislodged naturally during deployment. Re-sheathing was performed repeatedly. It was confirmed that the distal wire disconnected, and the distal side was deformed. Follow up response received with information that the catheter dislodged spontaneously (unexpectedly) during deployment.
 
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key10499441
MDR Text Key206124655
Report Number2029214-2020-00901
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-30
Device Catalogue NumberPED2-500-30
Device Lot NumberB002405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-