• 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. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE 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. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-25
Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  Malfunction  
Manufacturer Narrative

No device return so no product analysis could be performed. The cause of the event was not determined. Mdrs related to this event: 2029214-2018-00606 and this report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that a pflex (4. 75 mm x 25 mm) and an unknown pipeline product failed to open during a procedure to address an unruptured fusiform aneurysm located in the internal carotid artery (ica) posterior communicating artery segment. It was confirmed that the pipeline device and its accessories were prepped according to their indications for use (ifu). It was reported that the health care provider (hcp) attempted to open/flower the pipeline device in the m1 segment multiple times, but the device would not open after unsheathing 2/3 of the device; greater than 50% of the device was deployed. The hcp then attempted to position the device in the ica, but it again would not open. The device was removed from the microcatheter and rhv, and it was noted that the proximal end of the device looked crimped; however, only the middle part of the product was placed in a bend. Another device of the same size was used and it also would not open. The same diagnostics/troubleshooting were performed on the replacement device. It was noted, however, that the replacement device appeared normal upon removal and was not crimped. A 4. 5 mm x 25 mm pipeline device was then used and opened on the first attempt. It was confirmed that usage of the new size resulted in a good outcome. The patient's vessel tortuosity was noted as severe; however, there was no known impact or consequence to the patient. No further complications were reported/anticipated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key7673442
MDR Text Key114042284
Report Number2029214-2018-00609
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED-475-25
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 Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-