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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
0 0 0 0 0 1 8 0 6 3

Device Problems
Occlusion within device 244
Fracture 43
Deployment issue 33
Device operates differently than expected 7
No Known Device Problem 5
Break 5
Device expiration issue 4
Difficult to remove 4
Not Applicable 3
No Information 2
Kinked 2
Restricted flowrate 2
Bent 2
Difficult to deploy 1
Entrapment of device or device component 1
Use of Device Issue 1
Implant, removal of 1
Folded 1
Migration of device or device component 1
Difficult to advance 1
Human-Device Interface Issue 1
Total Device Problems 364

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

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

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