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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)
2014 2015 2016 2017 2018 2019
128 45 72 53 61 32

Device Problems
Stent 6267
Adverse Event Without Identified Device or Use Problem 5669
Bent 4039
Failure to Advance 3523
Material Deformation 3155
Device Dislodged or Dislocated 2842
Catheter 2705
Occlusion Within Device 1448
Break 1062
Device Damaged Prior to Use 972
Shaft 861
Difficult to Remove 838
Device Damaged by Another Device 542
Activation, Positioning or Separation Problem 350
Fracture 282
Difficult to Advance 265
Balloon 226
Inflation Problem 210
Material Rupture 194
Improper or Incorrect Procedure or Method 177
Entrapment of Device 166
Kinked 152
Obstruction of Flow 145
Deflation Problem 140
Material Separation 137
Leak / Splash 127
Detachment Of Device Component 113
Detachment of Device or device Component 97
Material Twisted / Bent 93
Migration or Expulsion of Device 86
Burst Container or Vessel 81
Activation Failure Including Expansion Failures 70
Difficult or Delayed Positioning 56
Patient-Device Incompatibility 56
Difficult To Position 55
Malposition of device 55
Device Expiration Issue 48
Defective Device 46
Stretched 41
Deformation Due to Compressive Stress 37
Device Contamination with Chemical or Other Material 35
Positioning Failure 35
Migration 32
Device Markings / Labelling Problem 25
Difficult to Insert 23
Device-Device Incompatibility 23
Material Integrity Problem 23
Tip 20
Premature Activation 20
Positioning Problem 19
Device Or Device Fragments Location Unknown 17
Difficult or Delayed Activation 16
Defective Component 16
Use of Device Problem 15
Inadequacy of Device Shape and/or Size 13
Insufficient Information 12
Contamination / decontamination Problem 12
Physical Resistance 11
Hole In Material 11
Product Quality Problem 10
Unintended System Motion 10
Component Missing 10
Contamination During Use 9
Tear, Rip or Hole in Device Packaging 9
Material Split, Cut or Torn 8
Unsealed Device Packaging 8
Off-Label Use 8
Material Distortion 8
Inaccurate Delivery 7
Unintended Movement 7
Device Packaging Compromised 6
Torn Material 6
Label 6
Failure To Adhere Or Bond 6
Unstable 6
Device Operates Differently Than Expected 6
Failure to Fold 5
Fluid Leak 5
Physical Resistance / Sticking 5
Peeled / Delaminated 4
Device Slipped 4
Material Puncture / Hole 4
Retraction Problem 4
Seal 3
Crack 3
Difficult to Open or Remove Packaging Material 3
Packaging Problem 3
Hub 3
Therapy Delivered to Incorrect Body Area 3
Expulsion 3
Patient Device Interaction Problem 3
Separation Failure 2
Loose or Intermittent Connection 2
Device Disinfection Or Sterilization Issue 2
Material Perforation 2
Mechanical Problem 2
Incorrect Measurement 2
Device Difficult to Setup or Prepare 2
Appropriate Term/Code Not Available 2
Human-Device Interface Problem 2
Total Device Problems 38009


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