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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 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 618 618
Device-Device Incompatibility 127 127
Adverse Event Without Identified Device or Use Problem 119 119
Complete Blockage 78 78
Obstruction of Flow 72 72
Patient-Device Incompatibility 62 62
Detachment of Device or Device Component 58 58
Failure to Advance 50 50
Material Deformation 40 40
Collapse 34 34
Migration 34 34
Premature Separation 32 32
Insufficient Information 30 30
Retraction Problem 28 28
Activation, Positioning or Separation Problem 27 27
Partial Blockage 22 22
Migration or Expulsion of Device 21 21
Device Stenosis 21 21
Material Rupture 19 19
Break 19 19
Difficult to Advance 19 19
Material Split, Cut or Torn 16 16
Appropriate Term/Code Not Available 15 15
Deformation Due to Compressive Stress 15 15
Occlusion Within Device 14 14
Difficult to Insert 14 14
Patient Device Interaction Problem 14 14
Inflation Problem 13 13
Difficult to Remove 12 12
Separation Problem 12 12
Physical Resistance 11 11
Deflation Problem 11 11
Leak/Splash 11 11
Positioning Failure 10 10
Fracture 10 10
Malposition of Device 10 10
Positioning Problem 10 10
Difficult to Open or Remove Packaging Material 9 9
Fluid/Blood Leak 9 9
Material Separation 8 8
Packaging Problem 8 8
Separation Failure 8 8
Improper or Incorrect Procedure or Method 7 7
Activation Failure 7 7
No Apparent Adverse Event 6 6
Inadequacy of Device Shape and/or Size 6 6
Material Invagination 6 6
Detachment Of Device Component 6 6
Unintended Movement 5 5
Physical Resistance/Sticking 5 5
Material Puncture/Hole 4 4
Sticking 4 4
Component Missing 4 4
Device Markings/Labelling Problem 4 4
Stretched 3 3
Burst Container or Vessel 3 3
Disconnection 3 3
Entrapment of Device 3 3
Difficult or Delayed Positioning 3 3
Activation Problem 3 3
Failure to Deflate 3 3
Device Handling Problem 2 2
Nonstandard Device 2 2
Loose or Intermittent Connection 2 2
Device Slipped 2 2
Premature Activation 2 2
Device Damaged Prior to Use 2 2
Defective Component 1 1
Microbial Contamination of Device 1 1
Fitting Problem 1 1
Material Perforation 1 1
Device Contamination with Body Fluid 1 1
Failure to Deliver 1 1
Structural Problem 1 1
Difficult or Delayed Activation 1 1
Folded 1 1
Device Operates Differently Than Expected 1 1
Delivery System Failure 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
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Perivalvular Leak 1 1
Difficult To Position 1 1
Mechanical Problem 1 1
Optical Decentration 1 1
Material Fragmentation 1 1
Bent 1 1
Backflow 1 1
Component Falling 1 1
Crack 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 536 536
No Consequences Or Impact To Patient 181 181
Obstruction/Occlusion 122 122
Thrombosis/Thrombus 79 79
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 35 35
No Code Available 28 28
Renal Failure 20 20
Foreign Body In Patient 19 19
Vascular Dissection 18 18
Death 17 17
Pain 15 15
Hemorrhage/Bleeding 13 13
Injury 12 12
Perforation of Vessels 12 12
Renal Impairment 11 11
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
Paraplegia 3 3
Ruptured Aneurysm 3 3
Perforation 3 3
Rupture 3 3
Thrombosis 2 2
Rash 2 2
Stroke/CVA 2 2
Abdominal Pain 2 2
Embolism 2 2
Exsanguination 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Foreign Body Embolism 2 2
Nervous System Injury 2 2
Ambulation Difficulties 2 2
Solid Tumour 2 2
Restenosis 2 2
Swelling/ Edema 1 1
Implant Pain 1 1
Unspecified Hepatic or Biliary Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Not Applicable 1 1
Thrombocytopenia 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Hypovolemic Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Extravasation 1 1
Embolus 1 1
Adhesion(s) 1 1
Transient Ischemic Attack 1 1
Shock 1 1
Complaint, Ill-Defined 1 1
Cardiogenic Shock 1 1
Jaundice 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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