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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device stent, superficial femoral artery
Definition Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Product CodeNIP
Device Class 3

Premarket Approvals (PMA)
2013 2014 2015 2016 2017 2018
21 42 40 50 34 17

Device Problems
Fracture 280
Deployment issue 278
Failure to deploy 165
Occlusion within device 162
No Known Device Problem 147
Difficult to remove 110
Break 104
Bent 80
Entrapment of device or device component 69
Premature deployment 68
Stretched 68
Material torqued 64
Device operates differently than expected 62
Material twisted 61
Difficult to deploy 57
Detachment of device component 53
Material deformation 41
Failure to advance 35
Detachment of device or device component 29
Retraction problem 18
Kinked 15
Misfire 14
Torn material 12
Malposition of device 10
Difficult to advance 10
Blockage within device or device component 10
Leak 10
No Information 9
Dislodged or dislocated 9
Migration of device or device component 9
Positioning Issue 8
Improper or incorrect procedure or method 7
Delivered as unsterile product 7
Failure to expand 6
Component missing 6
Inaccurate delivery 6
Mechanical issue 6
Difficult to position 6
Sticking 6
Mechanical jam 6
Device or device component damaged by another device 5
Device expiration issue 5
Device damaged prior to use 5
Physical resistance 5
Loss of or failure to bond 4
Device markings issue 4
Dent in material 4
Material separation 3
Defective component 3
Tear, rip or hole in device packaging 2
Contamination during use 2
Device inoperable 2
Incompatibility problem 2
Use of Device Issue 2
Obstruction within device 2
Peeled 2
Therapy delivered to incorrect body area 2
Size incorrect for patient 2
Difficult to insert 2
Instruction for use issue 2
Improper flow or infusion 2
Delivery system failure 1
Failure to disconnect 1
Material Distortion 1
Scratched material 1
Device misassembled during manufacturing or shipping 1
Foreign material present in device 1
Failure to separate 1
Hole in material 1
Material rigid or stiff 1
Device packaging compromised 1
Device clogged 1
Buckled material 1
Delamination 1
No code available 1
Material integrity issue 1
Total Device Problems 2200

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc I Oct-10-2013
2 Boston Scientific Corporation II Feb-22-2018
3 Cordis Corporation II Jun-06-2013
4 Ev3, Inc. II Jun-23-2016
5 Medtronic Inc. II Nov-29-2017
6 Terumo Medical Corp II Nov-29-2016

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