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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drug-eluting peripheral transluminal angioplasty catheter
Definition A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.
Product CodeONU
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 2 17 23 14 12 15 16 21 20 20 7

MDR Year MDR Reports MDR Events
2015 478 478
2016 492 492
2017 590 590
2018 545 545
2019 1054 1054
2020 454 454
2021 306 4950
2022 361 364
2023 485 485
2024 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3736 8139
Material Rupture 322 566
Inflation Problem 205 205
Burst Container or Vessel 139 139
Material Twisted/Bent 101 101
Defective Device 90 90
Leak/Splash 81 81
Difficult to Remove 70 70
Deflation Problem 66 66
Detachment of Device or Device Component 54 54
Occlusion Within Device 40 40
Entrapment of Device 30 30
Insufficient Information 29 29
Device-Device Incompatibility 22 22
Material Deformation 20 20
Difficult to Advance 15 15
Material Separation 15 15
Device Operates Differently Than Expected 14 14
Failure to Advance 13 13
Failure to Deflate 13 13
Break 13 13
Retraction Problem 12 12
Material Integrity Problem 11 11
Use of Device Problem 9 9
Device Expiration Issue 9 9
Fracture 7 7
Difficult to Insert 7 7
Material Split, Cut or Torn 7 7
Torn Material 7 7
Off-Label Use 5 5
Stretched 4 4
Obstruction of Flow 4 4
Appropriate Term/Code Not Available 4 4
Patient-Device Incompatibility 4 4
Device Contamination with Chemical or Other Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Scratched Material 2 2
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 2 2
Infusion or Flow Problem 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Device Difficult to Setup or Prepare 2 2
Improper or Incorrect Procedure or Method 2 2
Material Puncture/Hole 2 2
Crack 2 2
Detachment Of Device Component 1 1
Fluid/Blood Leak 1 1
Flushing Problem 1 1
Kinked 1 1
Delivered as Unsterile Product 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Unsealed Device Packaging 1 1
Unraveled Material 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged by Another Device 1 1
Biocompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Improper Flow or Infusion 1 1
Compatibility Problem 1 1
Physical Resistance/Sticking 1 1
Inaccurate Information 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Output Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reocclusion 1569 1569
Stenosis 670 679
No Consequences Or Impact To Patient 515 515
No Clinical Signs, Symptoms or Conditions 477 721
Death 424 1278
Occlusion 255 255
Vascular Dissection 231 355
Insufficient Information 177 909
Obstruction/Occlusion 129 617
Restenosis 107 107
Intimal Dissection 96 96
Thrombosis 81 81
Ischemia 74 74
Thrombosis/Thrombus 69 69
Pain 64 64
Injury 52 52
Claudication 50 50
Thrombus 47 47
Patient Problem/Medical Problem 41 41
Embolism 36 36
Arteriosclerosis/ Atherosclerosis 32 32
Embolism/Embolus 30 32
Cancer 28 638
Pseudoaneurysm 25 25
Hemorrhage/Bleeding 25 25
Perforation 23 23
Reaction 23 23
Necrosis 22 22
Hypersensitivity/Allergic reaction 22 22
Aneurysm 19 19
Unspecified Infection 18 18
No Known Impact Or Consequence To Patient 18 18
No Code Available 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 384
Gangrene 14 14
Hematoma 14 14
Myocardial Infarction 12 12
Swelling 12 12
Pneumonia 10 132
Stroke/CVA 10 10
No Information 10 10
Unspecified Tissue Injury 9 9
Foreign Body In Patient 9 9
Cardiac Arrest 8 252
Perforation of Vessels 8 8
Renal Failure 7 7
Swelling/ Edema 7 7
Vasoconstriction 6 6
No Patient Involvement 6 6
Heart Failure/Congestive Heart Failure 6 738
Rash 6 6
Peripheral Vascular Disease 6 7
Atherosclerosis 6 6
Cellulitis 6 6
Cardiomyopathy 5 127
Embolus 5 5
Intracranial Hemorrhage 5 5
Rupture 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Post Operative Wound Infection 5 5
Unspecified Vascular Problem 4 4
Ulcer 4 4
Pressure Sores 4 4
Sepsis 4 4
High Blood Pressure/ Hypertension 4 4
Inflammation 4 4
Calcium Deposits/Calcification 4 4
Low Blood Pressure/ Hypotension 3 3
Discomfort 3 3
Cardiovascular Insufficiency 3 3
Vascular System (Circulation), Impaired 3 3
Respiratory Failure 2 2
Numbness 2 2
Device Embedded In Tissue or Plaque 2 2
Respiratory Insufficiency 2 2
Gastrointestinal Hemorrhage 2 124
Multiple Organ Failure 2 2
Constipation 2 2
Bone Fracture(s) 2 2
Dementia 2 2
Pulmonary Embolism 2 2
Vessel Or Plaque, Device Embedded In 2 2
Anemia 2 2
Anaphylactic Shock 1 1
Bradycardia 1 1
Myocardial Contusion 1 1
Cardiopulmonary Arrest 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Dehydration 1 1
Dyspnea 1 1
Edema 1 1
Erythema 1 1
Extravasation 1 1
Fever 1 1
Hyperbilirubinemia 1 1
Liver Damage/Dysfunction 1 1
Muscle Spasm(s) 1 1
Neuropathy 1 1
Skin Discoloration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular, Inc. II May-06-2022
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