• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device stent, superficial femoral artery, drug-eluting
Definition Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodeNIU
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 1 8 0 6 5 0

Device Problems
Occlusion within device 296
Fracture 53
Deployment issue 47
Bent 8
Break 7
Device operates differently than expected 7
Difficult to remove 7
No Known Device Problem 7
Difficult to deploy 4
Device expiration issue 4
Not Applicable 3
Entrapment of device or device component 3
No Information 2
Restricted flowrate 2
Kinked 2
Difficult to advance 2
Human-Device Interface Issue 1
Device or device component damaged by another device 1
Stretched 1
Use of Device Issue 1
Implant, removal of 1
Folded 1
Migration of device or device component 1
Failure to deploy 1
Total Device Problems 462

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cook, Inc. I May-15-2013

-
-