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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Definition An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Product CodePFV
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 1 16 12 6

Device Problems
Failure to deploy 21
Fracture 17
Material perforation 7
Malposition of device 4
Difficult to advance 4
Material deformation 4
Deployment issue 3
Break 3
Detachment of device or device component 2
Difficult to insert 2
Premature deployment 2
Failure to advance 2
Split 1
Device Difficult to Setup or Prepare 1
Material separation 1
Stretched 1
Use of Device Issue 1
Kinked 1
Device operates differently than expected 1
Device-device incompatibility 1
Difficult to deploy 1
Device damaged prior to use 1
Out-of-box failure 1
Total Device Problems 82

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