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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)
2020 2021 2022 2023 2024 2025
6 5 6 9 8 0

MDR Year MDR Reports MDR Events
2020 183 183
2021 235 235
2022 287 287
2023 303 303
2024 448 448
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 593 593
Adverse Event Without Identified Device or Use Problem 125 125
Complete Blockage 103 103
Device-Device Incompatibility 95 95
Material Deformation 80 80
Obstruction of Flow 76 76
Detachment of Device or Device Component 73 73
Patient-Device Incompatibility 65 65
Retraction Problem 48 48
Failure to Advance 44 44
Premature Separation 44 44
Migration 44 44
Device Stenosis 43 43
Collapse 40 40
Insufficient Information 35 35
Difficult to Advance 25 25
Partial Blockage 24 24
Break 23 23
Activation, Positioning or Separation Problem 23 23
Material Rupture 22 22
Difficult to Open or Remove Packaging Material 20 20
Appropriate Term/Code Not Available 20 20
Fracture 17 17
Migration or Expulsion of Device 17 17
Difficult to Remove 17 17
Malposition of Device 15 15
Separation Failure 15 15
Deformation Due to Compressive Stress 15 15
Positioning Failure 14 14
Difficult to Insert 13 13
Patient Device Interaction Problem 13 13
Deflation Problem 13 13
Inflation Problem 12 12
Separation Problem 12 12
Inaccurate Information 12 12
Expiration Date Error 12 12
Material Split, Cut or Torn 11 11
Leak/Splash 11 11
Fluid/Blood Leak 11 11
Material Separation 10 10
Positioning Problem 10 10
Activation Failure 10 10
Material Integrity Problem 9 9
Packaging Problem 8 8
Improper or Incorrect Procedure or Method 8 8
Inadequacy of Device Shape and/or Size 7 7
Material Invagination 6 6
No Apparent Adverse Event 6 6
Physical Resistance/Sticking 5 5
Premature Activation 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 763 763
Obstruction/Occlusion 153 153
Thrombosis/Thrombus 95 95
Aneurysm 58 58
Insufficient Information 55 55
Stenosis 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
No Consequences Or Impact To Patient 43 43
Occlusion 36 36
No Code Available 24 24
Foreign Body In Patient 22 22
Renal Impairment 21 21
No Known Impact Or Consequence To Patient 21 21
Renal Failure 20 20
Vascular Dissection 20 20
Perforation of Vessels 18 18
Hemorrhage/Bleeding 17 17
Pain 15 15
No Patient Involvement 13 13
Low Blood Pressure/ Hypotension 10 10
Unspecified Infection 10 10
Ischemia 8 8
Unspecified Vascular Problem 8 8
Death 7 7
Failure of Implant 5 5
Pseudoaneurysm 5 5
Injury 4 4
Device Embedded In Tissue or Plaque 4 4
Paraplegia 3 3
Rupture 3 3
Thrombus 3 3
Perforation 3 3
Foreign Body Embolism 3 3
Ruptured Aneurysm 3 3
Blood Loss 3 3
Restenosis 3 3
Hematoma 3 3
Calcium Deposits/Calcification 3 3
Abdominal Pain 3 3
No Information 2 2
Nervous System Injury 2 2
Multiple Organ Failure 2 2
Solid Tumour 2 2
Thrombosis 2 2
Exsanguination 2 2
Stroke/CVA 2 2
Claudication 2 2
Not Applicable 1 1
Thrombocytopenia 1 1
Arteriosclerosis/ Atherosclerosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Oct-07-2024
2 Atrium Medical Corporation II Nov-11-2023
3 W L Gore & Associates, Inc. II Aug-30-2024
4 W L Gore & Associates, Inc. II Oct-08-2021
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