• 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 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 LASER THERAPY PRODUCT Back to Search Results
Model Number PED-375-35
Device Problems Break (1069); Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/24/2020
Event Type  Injury  
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 had resistance with a marksman microcatheter and became broken. The patient was being treated for an unruptured saccular aneurysm of the left cavernous sinus artery. The aneurysm max diameter was 25mm and the neck diameter was 6mm. Vessel tortuosity was minimal. It was reported that the marksman microcatheter navigated to the m2 segment of the middle cerebral artery. While the pipeline was being advanced through the marksman catheter there was significant resistance starting at the middle section of the catheter through to the end. When the pipeline was being deployed, it was noted that the distal end of the pipeline was not opening completely. It was resheathed and deployment attempted multiple times but was still not opening as desired. The surgeon withdrew the catheter and pipeline together and noted that there was resistance with withdrawal as well. After removal from the patient, it was observed that the protective sheath and part of the pipeline were partly broken and it appeared the portion of the pipeline that had deployed remained implanted in the patient. The surgeon was concerned about potential for injury to the patient's vessels but angio revealed that there was no obstruction of the patient's vessels. A new marksman and pipeline were then placed immediately. There was no harm or injury to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10089580
MDR Text Key192151884
Report Number2029214-2020-00490
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 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-35
Device Catalogue NumberPED-375-35
Device Lot NumberA887314
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/26/2020 Patient Sequence Number: 1
-
-