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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device iliac covered stent, arterial
Definition For the treatment of de novo or restenotic lesions found in iliac arteries
Product CodePRL
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 7 14 9 6 5 6 9 2

MDR Year MDR Reports MDR Events
2017 91 91
2018 102 102
2019 99 99
2020 183 183
2021 235 235
2022 287 287
2023 303 303
2024 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 597 597
Device-Device Incompatibility 123 123
Adverse Event Without Identified Device or Use Problem 115 115
Complete Blockage 73 73
Obstruction of Flow 71 71
Patient-Device Incompatibility 62 62
Detachment of Device or Device Component 56 56
Failure to Advance 47 47
Material Deformation 40 40
Collapse 34 34
Migration 34 34
Premature Separation 32 32
Insufficient Information 30 30
Retraction Problem 26 26
Activation, Positioning or Separation Problem 26 26
Partial Blockage 22 22
Device Stenosis 20 20
Break 18 18
Material Rupture 18 18
Migration or Expulsion of Device 18 18
Difficult to Advance 18 18
Material Split, Cut or Torn 16 16
Deformation Due to Compressive Stress 15 15
Occlusion Within Device 14 14
Difficult to Insert 14 14
Patient Device Interaction Problem 14 14
Appropriate Term/Code Not Available 13 13
Inflation Problem 13 13
Difficult to Remove 12 12
Separation Problem 12 12
Physical Resistance 11 11
Leak/Splash 11 11
Deflation Problem 11 11
Positioning Failure 10 10
Positioning Problem 10 10
Difficult to Open or Remove Packaging Material 9 9
Malposition of Device 9 9
Fluid/Blood Leak 9 9
Fracture 9 9
Material Separation 8 8
Separation Failure 8 8
Packaging Problem 8 8
Activation Failure 7 7
Improper or Incorrect Procedure or Method 7 7
Inadequacy of Device Shape and/or Size 6 6
Material Invagination 6 6
Detachment Of Device Component 6 6
Unintended Movement 5 5
No Apparent Adverse Event 5 5
Physical Resistance/Sticking 5 5
Device Markings/Labelling Problem 4 4
Sticking 4 4
Component Missing 4 4
Material Puncture/Hole 4 4
Burst Container or Vessel 3 3
Disconnection 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 3 3
Stretched 3 3
Activation Problem 3 3
Failure to Deflate 3 3
Device Handling Problem 2 2
Device Damaged Prior to Use 2 2
Nonstandard Device 2 2
Device Slipped 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 1 1
Optical Decentration 1 1
Perivalvular Leak 1 1
Difficult To Position 1 1
Premature Activation 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Material Fragmentation 1 1
Bent 1 1
Backflow 1 1
Component Falling 1 1
Crack 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1
Failure to Deliver 1 1
Fitting Problem 1 1
Material Perforation 1 1
Difficult or Delayed Activation 1 1
Structural Problem 1 1
Folded 1 1
Delivery System Failure 1 1
Device Operates Differently Than Expected 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1
Torn Material 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Output Problem 1 1
Incomplete or Inadequate Connection 1 1
Incomplete or Inadequate Priming 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 508 508
No Consequences Or Impact To Patient 181 181
Obstruction/Occlusion 118 118
Thrombosis/Thrombus 78 78
No Known Impact Or Consequence To Patient 73 73
Stenosis 64 64
Aneurysm 60 60
No Patient Involvement 56 56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Occlusion 40 40
Insufficient Information 34 34
No Code Available 28 28
Renal Failure 19 19
Foreign Body In Patient 18 18
Vascular Dissection 17 17
Death 17 17
Pain 14 14
Hemorrhage/Bleeding 13 13
Perforation of Vessels 12 12
Injury 12 12
Renal Impairment 10 10
Unspecified Infection 10 10
Ischemia 9 9
No Information 9 9
Unspecified Vascular Problem 8 8
Failure of Implant 7 7
Calcium Deposits/Calcification 6 6
Claudication 6 6
Thrombus 5 5
Device Embedded In Tissue or Plaque 4 4
Blood Loss 3 3
Pseudoaneurysm 3 3
Ruptured Aneurysm 3 3
Rupture 3 3
Paraplegia 3 3
Perforation 3 3
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Stroke/CVA 2 2
Embolism 2 2
Exsanguination 2 2
Hematoma 2 2
Ambulation Difficulties 2 2
Thrombosis 2 2
Nervous System Injury 2 2
Solid Tumour 2 2
Foreign Body Embolism 2 2
Restenosis 2 2
Swelling/ Edema 1 1
Implant Pain 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Not Applicable 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Unspecified Hepatic or Biliary Problem 1 1
Thrombocytopenia 1 1
Transient Ischemic Attack 1 1
Laceration(s) 1 1
Shock 1 1
Complaint, Ill-Defined 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Adhesion(s) 1 1
Extravasation 1 1
Embolus 1 1
Hypovolemic Shock 1 1
Hypersensitivity/Allergic reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Nov-11-2023
2 Bard Peripheral Vascular Inc II Dec-19-2019
3 W L Gore & Associates, Inc. II Oct-08-2021
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