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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)
2019 2020 2021 2022 2023 2024
15 16 21 20 20 7

MDR Year MDR Reports MDR Events
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 2115 6518
Material Rupture 235 479
Inflation Problem 95 95
Burst Container or Vessel 90 90
Material Twisted/Bent 89 89
Leak/Splash 61 61
Deflation Problem 40 40
Difficult to Remove 40 40
Detachment of Device or Device Component 36 36
Entrapment of Device 30 30
Device-Device Incompatibility 16 16
Material Separation 15 15
Failure to Deflate 13 13
Material Integrity Problem 11 11
Failure to Advance 11 11
Break 11 11
Difficult to Advance 10 10
Material Deformation 9 9
Use of Device Problem 9 9
Difficult to Insert 7 7
Fracture 7 7
Off-Label Use 4 4
Retraction Problem 4 4
Obstruction of Flow 4 4
Material Split, Cut or Torn 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Material Puncture/Hole 2 2
Device Difficult to Setup or Prepare 2 2
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
Flushing Problem 1 1
Difficult or Delayed Positioning 1 1
Crack 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Stretched 1 1
Unraveled Material 1 1
Insufficient 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
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Physical Resistance/Sticking 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reocclusion 856 856
No Clinical Signs, Symptoms or Conditions 477 721
Death 306 1160
Stenosis 261 270
Vascular Dissection 197 321
Insufficient Information 177 909
No Consequences Or Impact To Patient 140 140
Obstruction/Occlusion 129 617
Restenosis 107 107
Thrombosis/Thrombus 69 69
Ischemia 62 62
Pain 45 45
Injury 44 44
Occlusion 34 34
Arteriosclerosis/ Atherosclerosis 32 32
Embolism/Embolus 30 32
Hemorrhage/Bleeding 22 22
Cancer 21 631
Aneurysm 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 384
Necrosis 16 16
Patient Problem/Medical Problem 16 16
Pseudoaneurysm 16 16
Perforation 15 15
Unspecified Infection 14 14
Thrombosis 14 14
Embolism 13 13
Hematoma 12 12
Intimal Dissection 11 11
Gangrene 10 10
Thrombus 10 10
Unspecified Tissue Injury 9 9
Foreign Body In Patient 8 8
Hypersensitivity/Allergic reaction 8 8
Pneumonia 7 129
Renal Failure 7 7
Swelling/ Edema 7 7
Heart Failure/Congestive Heart Failure 6 738
Perforation of Vessels 6 6
No Known Impact Or Consequence To Patient 6 6
Myocardial Infarction 6 6
Cellulitis 6 6
Cardiac Arrest 6 250
Cardiomyopathy 5 127
Stroke/CVA 5 5
Intracranial Hemorrhage 5 5
Claudication 5 5
Post Operative Wound Infection 5 5
Chronic Obstructive Pulmonary Disease (COPD) 5 5
Rupture 4 4
Pressure Sores 4 4
Sepsis 4 4
Inflammation 4 4
Atherosclerosis 4 4
Unspecified Vascular Problem 4 4
Cardiovascular Insufficiency 3 3
Low Blood Pressure/ Hypotension 3 3
Discomfort 3 3
Ulcer 2 2
Swelling 2 2
Respiratory Failure 2 2
No Patient Involvement 2 2
Numbness 2 2
Anemia 2 2
No Information 2 2
Multiple Organ Failure 2 2
Respiratory Insufficiency 2 2
Gastrointestinal Hemorrhage 2 124
Cramp(s) /Muscle Spasm(s) 1 1
Pulmonary Hypertension 1 1
Myocardial Contusion 1 1
Bradycardia 1 1
Pulmonary Embolism 1 1
Anaphylactic Shock 1 1
Chest Pain 1 1
Dyspnea 1 1
Erythema 1 1
Extravasation 1 1
Pulmonary Edema 1 1
Local Reaction 1 1
Neuropathy 1 1
Peripheral Vascular Disease 1 1
Impaired Healing 1 1
Reaction 1 1
Movement Disorder 1 1
Hemorrhagic Stroke 1 1
Paresthesia 1 1
Electrolyte Imbalance 1 1
Urinary Tract Infection 1 1
Vasoconstriction 1 1
Cardiogenic Shock 1 1

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