• 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 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. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-20
Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2018
Event Type  Malfunction  
Manufacturer Narrative

No device return so no product analysis could be performed. The cause of the event was not determined. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-425-20. Mdrs related to this event: this report, 2029214-2018-00623 and 2029214-2018-00624. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information that during deployment of a pipeline product, the device would not open in the middle section. The pipeline devices were not used off-label and were prepared according to their indications for use (ifu). The product was also noted to have been manipulated normally while the middle section of the device was being deployed around a bend. The accessory products included the following: 6fr shuttle sheath, 5fr sophia. It was also confirmed that the patient's anatomy was normal. It was reported that upon deployment of a pipeline stent for a right internal carotid artery (ica) blister / unruptured aneurism, the product did not open more than 50% in the middle section. It was also noted that the product was twisted and flattened out. The product was re-sheathed twice and deployed again without success. The pipeline device was removed from the patient and it was discovered that it was "jammed in the marksman" catheter. Two addition pipeline devices and marksman guide catheters were used but the same issue occurred. An lvis jrn product was then inserted and removed as the event recurred again. 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 W/SHIELD TECHNOLOGY
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7688920
MDR Text Key114676424
Report Number2029214-2018-00622
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP100018.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,Followup
Report Date 10/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/19/2020
Device MODEL NumberPED2-425-20
Device Catalogue NumberPED2-425-20
Device LOT NumberA448269
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/27/2018
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? Yes
Date Device Manufactured04/20/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-