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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, iliac
Definition Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Product CodeNIO
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
27 22 18 16 22 0

Device Problems
Stent 336
Device Dislodged or Dislocated 197
Adverse Event Without Identified Device or Use Problem 194
Difficult to Remove 122
Activation, Positioning or Separation Problem 121
Premature Activation 79
Difficult or Delayed Positioning 74
Detachment of Device or device Component 68
Failure to Advance 60
Material Deformation 56
Catheter 54
Difficult to Advance 52
Positioning Failure 52
Fracture 48
Bent 42
Break 41
Occlusion Within Device 40
Improper or Incorrect Procedure or Method 40
Migration or Expulsion of Device 33
Activation Failure Including Expansion Failures 28
Device Contaminated during manufacture or shipping 28
Obstruction of Flow 28
Off-Label Use 25
Device Damaged Prior to Use 23
Entrapment of Device 23
Tip 21
Detachment Of Device Component 19
Material Frayed 18
Collapse 18
Difficult or Delayed Activation 17
Positioning Problem 17
Patient-Device Incompatibility 16
Material Separation 15
Mechanical Jam 15
Insufficient Information 14
Shaft 14
Difficult To Position 14
Malposition of device 14
Deformation Due to Compressive Stress 13
Device Expiration Issue 13
Torn Material 11
Device Damaged by Another Device 10
Material Rupture 10
Misfire 10
Device Markings / Labelling Problem 10
Stretched 10
Defective Component 10
Migration 9
Defective Device 9
Partial Blockage 9
Premature Separation 9
Device Operates Differently Than Expected 8
Device Contamination with Chemical or Other Material 7
Balloon 7
Delivery System Failure 7
Physical Resistance / Sticking 7
Unsealed Device Packaging 6
Device Deployer 6
Complete Blockage 6
Use of Device Problem 6
Inflation Problem 5
Sticking 5
Appropriate Term/Code Not Available 5
Material Split, Cut or Torn 5
Burst Container or Vessel 5
Kinked 5
Inaccurate Delivery 4
Inadequacy of Device Shape and/or Size 4
Failure To Adhere Or Bond 4
Material Integrity Problem 4
Deflation Problem 4
Retraction Problem 4
Patient Device Interaction Problem 3
Material Twisted / Bent 3
Physical Resistance 3
Unstable 3
Leak / Splash 3
Component Missing 3
Contamination / decontamination Problem 2
Material Fragmentation 2
Difficult to Insert 2
Tear, Rip or Hole in Device Packaging 2
Packaging Problem 2
Unintended Movement 2
Guidewire 2
Misassembled 1
Compatibility Problem 1
Product Quality Problem 1
Accessory Incompatible 1
Crack 1
Unintended System Motion 1
Unintended Ejection 1
Failure to Disconnect 1
Device-Device Incompatibility 1
Noise, Audible 1
Flushing problem 1
Separation Problem 1
Labelling, Instructions for Use or Training Problem 1
Therapy Delivered to Incorrect Body Area 1
Device Slipped 1
Total Device Problems 2370

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Dec-20-2019
2 Cook Medical Incorporated II Jan-22-2016

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