• 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 PED2-400-25
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the pipeline prematurely opened inside the microcatheter. The physician reported pipeline released from the silicone ped, still inside the microcatheter. There was no possibility to redeem the device. As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required. Additional information was required to investigate the event and/or determine the cause of the event. The hcp was contacted to help with the investigation and information was received stating that the pipeline was implanted within the patient. It was implanted as near as possible to the aneurysm. The vessel anatomy was reported to have been normal. A continuous flush was used. Difficulty was experienced within the catheter, upon deployment. A second pipeline was required to achieve full neck coverage. The device did open fully. As the device remains in the patient, no analysis could be performed. There was no indication that the event was related to a possible manufacturing issue, so a device history record review was not performed. The investigation determined that this was a known event. Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that this medtronic flow diverter device encountered difficulties when it was implanted. The device did not provide enough aneurysm neck coverage, which required a second flow diverter to achieve full neck coverage. The patient was undergoing treatment of an unruptured internal carotid artery (ica) aneurysm located in ophthalmic segment. No patient injury was reported. Reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
 
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key9106740
MDR Text Key165129426
Report Number2029214-2019-00945
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2021
Device Model NumberPED2-400-25
Device Catalogue NumberPED2-400-25
Device Lot NumberA589923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-