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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent, iliac vein
Definition A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Product CodeQAN
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
0 0 0 4 10 6

MDR Year MDR Reports MDR Events
2019 24 24
2020 117 117
2021 363 363

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 293 293
Adverse Event Without Identified Device or Use Problem 51 51
Material Deformation 36 36
Fracture 34 34
Migration 31 31
Positioning Failure 27 27
Activation, Positioning or SeparationProblem 26 26
Entrapment of Device 25 25
Misfire 19 19
Migration or Expulsion of Device 14 14
Difficult to Remove 13 13
Difficult or Delayed Positioning 10 10
Malposition of Device 10 10
Break 9 9
Material Twisted/Bent 8 8
Obstruction of Flow 7 7
Detachment of Device or Device Component 6 6
Positioning Problem 5 5
Device Markings/Labelling Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Appropriate Term/Code Not Available 4 4
Loss of or Failure to Bond 4 4
Off-Label Use 4 4
Use of Device Problem 3 3
Premature Activation 3 3
Deformation Due to Compressive Stress 3 3
Device-Device Incompatibility 3 3
Material Integrity Problem 3 3
Failure to Advance 2 2
Device Damaged by Another Device 2 2
Human-Device Interface Problem 2 2
Inaccurate Information 2 2
Mechanical Problem 2 2
Retraction Problem 2 2
Nonstandard Device 2 2
Labelling, Instructions for Use or Training Problem 1 1
No Display/Image 1 1
Material Too Rigid or Stiff 1 1
Material Separation 1 1
Activation Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Difficult or Delayed Activation 1 1
Device Damaged Prior to Use 1 1
Poor Quality Image 1 1
Device Contamination with Chemical or Other Material 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 358 358
Thrombosis/Thrombus 33 33
No Consequences Or Impact To Patient 27 27
Obstruction/Occlusion 18 18
Pain 13 13
Chest Pain 8 8
No Known Impact Or Consequence To Patient 8 8
Stenosis 8 8
Insufficient Information 8 8
Swelling/ Edema 5 5
Injury 5 5
No Code Available 5 5
Dyspnea 5 5
Swelling 5 5
Reocclusion 4 4
Thrombosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Tissue Injury 4 4
Restenosis 3 3
Device Embedded In Tissue or Plaque 3 3
Cellulitis 3 3
Hemorrhage/Bleeding 3 3
Hypersensitivity/Allergic reaction 2 2
Occlusion 2 2
Failure of Implant 2 2
Pericardial Effusion 2 2
Embolism/Embolus 2 2
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Ulcer 2 2
Unspecified Heart Problem 2 2
Respiratory Insufficiency 2 2
Perforation of Vessels 1 1
Cardiac Tamponade 1 1
Hematuria 1 1
Inflammation 1 1
Nerve Damage 1 1
Tachycardia 1 1
Paralysis 1 1
High Blood Pressure/ Hypertension 1 1
Intimal Dissection 1 1
Arrhythmia 1 1
Edema 1 1
Extravasation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Jun-17-2021
2 Boston Scientific Corporation I May-19-2021
3 Medtronic Inc. II May-05-2021
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