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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary drug-eluting stent
Definition Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product CodeNIQ
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
45 72 53 61 59 2

Device Problems
Adverse Event Without Identified Device or Use Problem 6586
Stent 6262
Bent 4030
Material Deformation 3996
Failure to Advance 3855
Device Dislodged or Dislocated 3149
Catheter 2700
Occlusion Within Device 1410
Break 1192
Device Damaged Prior to Use 971
Difficult to Remove 963
Shaft 857
Device Damaged by Another Device 559
Difficult to Advance 363
Activation, Positioning or Separation Problem 359
Fracture 305
Inflation Problem 239
Material Rupture 227
Balloon 226
Improper or Incorrect Procedure or Method 224
Material Separation 190
Entrapment of Device 182
Obstruction of Flow 175
Deflation Problem 161
Kinked 152
Leak / Splash 138
Detachment of Device or device Component 116
Detachment Of Device Component 113
Material Twisted / Bent 93
Activation Failure Including Expansion Failures 90
Burst Container or Vessel 89
Migration or Expulsion of Device 88
Patient-Device Incompatibility 67
Defective Device 63
Difficult or Delayed Positioning 62
Malposition of device 56
Difficult To Position 55
Device Expiration Issue 48
Deformation Due to Compressive Stress 47
Stretched 41
Migration 38
Positioning Failure 38
Device Contamination with Chemical or Other Material 37
Device-Device Incompatibility 34
Device Markings / Labelling Problem 27
Material Integrity Problem 27
Difficult to Insert 25
Positioning Problem 23
Difficult or Delayed Activation 21
Tip 20
Premature Activation 20
Use of Device Problem 18
Insufficient Information 18
Device Or Device Fragments Location Unknown 17
Defective Component 17
Contamination During Use 14
Contamination / decontamination Problem 13
Inadequacy of Device Shape and/or Size 13
Tear, Rip or Hole in Device Packaging 11
Unintended System Motion 11
Physical Resistance 11
Hole In Material 11
Component Missing 11
Material Split, Cut or Torn 10
Unintended Movement 10
Product Quality Problem 10
Unsealed Device Packaging 9
Off-Label Use 9
Physical Resistance / Sticking 8
Material Distortion 8
Patient Device Interaction Problem 8
Inaccurate Delivery 7
Unstable 6
Device Packaging Compromised 6
Label 6
Material Puncture / Hole 6
Failure To Adhere Or Bond 6
Torn Material 6
Device Operates Differently Than Expected 5
Fluid Leak 5
Failure to Fold 5
Device Slipped 4
Human-Device Interface Problem 4
Packaging Problem 4
Retraction Problem 4
Peeled / Delaminated 4
Crack 3
Hub 3
Expulsion 3
Difficult to Open or Remove Packaging Material 3
Therapy Delivered to Incorrect Body Area 3
Seal 3
No Apparent Adverse Event 3
Appropriate Term/Code Not Available 3
Loose or Intermittent Connection 3
Device Difficult to Setup or Prepare 2
Infusion or Flow Problem 2
Material Perforation 2
Component Misassembled 2
Mechanical Problem 2
Total Device Problems 41161


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