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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)
2019 2020 2021 2022 2023 2024
9 6 5 6 9 2

MDR Year MDR Reports MDR Events
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 509 509
Adverse Event Without Identified Device or Use Problem 108 108
Device-Device Incompatibility 83 83
Complete Blockage 73 73
Obstruction of Flow 64 64
Patient-Device Incompatibility 60 60
Detachment of Device or Device Component 55 55
Material Deformation 39 39
Migration 34 34
Failure to Advance 34 34
Collapse 34 34
Premature Separation 32 32
Insufficient Information 28 28
Retraction Problem 25 25
Partial Blockage 22 22
Activation, Positioning or Separation Problem 20 20
Device Stenosis 20 20
Difficult to Advance 16 16
Break 16 16
Material Rupture 16 16
Migration or Expulsion of Device 15 15
Deformation Due to Compressive Stress 15 15
Material Split, Cut or Torn 14 14
Patient Device Interaction Problem 14 14
Inflation Problem 13 13
Separation Problem 12 12
Leak/Splash 11 11
Deflation Problem 11 11
Positioning Failure 10 10
Difficult to Remove 10 10
Appropriate Term/Code Not Available 10 10
Difficult to Open or Remove Packaging Material 9 9
Malposition of Device 9 9
Difficult to Insert 9 9
Fluid/Blood Leak 9 9
Fracture 9 9
Material Separation 8 8
Separation Failure 8 8
Packaging Problem 8 8
Positioning 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
Physical Resistance/Sticking 5 5
Device Markings/Labelling Problem 4 4
Material Puncture/Hole 4 4
Stretched 3 3
Disconnection 3 3
Difficult or Delayed Positioning 3 3
Component Missing 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Failure to Deflate 3 3
Unintended Movement 2 2
Device Handling Problem 2 2
Entrapment of Device 2 2
Device Damaged Prior to Use 2 2
Defective Component 1 1
Microbial Contamination of Device 1 1
Material Perforation 1 1
Backflow 1 1
Device Slipped 1 1
Nonstandard Device 1 1
Perivalvular Leak 1 1
Premature Activation 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Burst Container or Vessel 1 1
Crack 1 1
Material Fragmentation 1 1
Optical Decentration 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 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
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Difficult or Delayed Activation 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 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
Obstruction/Occlusion 118 118
No Consequences Or Impact To Patient 97 97
Thrombosis/Thrombus 78 78
Aneurysm 59 59
Stenosis 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Occlusion 38 38
No Patient Involvement 37 37
Insufficient Information 34 34
No Code Available 25 25
No Known Impact Or Consequence To Patient 22 22
Renal Failure 18 18
Vascular Dissection 17 17
Foreign Body In Patient 16 16
Pain 13 13
Hemorrhage/Bleeding 13 13
Death 13 13
Injury 11 11
Renal Impairment 10 10
Unspecified Infection 10 10
Perforation of Vessels 10 10
Ischemia 8 8
Unspecified Vascular Problem 8 8
Failure of Implant 6 6
Thrombus 3 3
Rupture 3 3
Paraplegia 3 3
Calcium Deposits/Calcification 3 3
Perforation 3 3
Ruptured Aneurysm 3 3
Blood Loss 3 3
Device Embedded In Tissue or Plaque 3 3
Pseudoaneurysm 2 2
Nervous System Injury 2 2
No Information 2 2
Solid Tumour 2 2
Foreign Body Embolism 2 2
Restenosis 2 2
Rash 2 2
Low Blood Pressure/ Hypotension 2 2
Stroke/CVA 2 2
Hematoma 2 2
Embolism 2 2
Exsanguination 2 2
Claudication 2 2
Thrombosis 2 2
Transient Ischemic Attack 1 1
Laceration(s) 1 1
Shock 1 1
Complaint, Ill-Defined 1 1
Cardiogenic Shock 1 1
Jaundice 1 1
Extravasation 1 1
Adhesion(s) 1 1
Hypovolemic Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Swelling/ Edema 1 1
Implant Pain 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Thrombocytopenia 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Unspecified Hepatic or Biliary Problem 1 1
Not Applicable 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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