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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, angioplasty, laser, coronary
Product CodeLPC
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
7 10 8 2 1 2

MDR Year MDR Reports MDR Events
2016 12 12
2017 21 21
2018 16 16
2019 19 19
2020 7 7
2021 5 127

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 14 14
Detachment of Device or Device Component 10 10
Material Deformation 5 5
Material Split, Cut or Torn 4 4
Device Dislodged or Dislocated 3 3
Break 3 3
Device Displays Incorrect Message 3 3
Material Integrity Problem 2 2
Detachment Of Device Component 2 2
Difficult to Remove 2 2
Material Protrusion/Extrusion 2 2
Device Operates Differently Than Expected 2 2
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Separation 1 1
Use of Device Problem 1 1
Failure to Calibrate 1 1
Incorrect Or Inadequate Test Results 1 1
Defective Device 1 1
Crack 1 1
Failure to Cycle 1 1
Failure to Deliver Energy 1 123
Fracture 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Component Falling 1 1
Material Frayed 1 1
Sticking 1 1
Solder Joint Fracture 1 1
Failure to Advance 1 1
Failure to Fire 1 1
Pressure Problem 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 24 24
Iatrogenic Source 18 18
No Known Impact Or Consequence To Patient 13 13
Radiation Exposure, Unintended 9 9
Death 8 8
Perforation of Vessels 7 7
No Consequences Or Impact To Patient 7 7
Cardiac Perforation 6 6
Hemorrhage/Bleeding 5 5
Device Embedded In Tissue or Plaque 5 5
Injury 3 3
Vascular Dissection 3 3
Insufficient Information 2 2
Low Blood Pressure/ Hypotension 2 2
Occlusion 1 1
Aneurysm 1 1
No Clinical Signs, Symptoms or Conditions 1 123
Cardiac Tamponade 1 1
Atrial Perforation 1 1
No Information 1 1
Angina 1 1
Chest Pain 1 1
Shock 1 1
Stenosis 1 1
Pseudoaneurysm 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spectranetics Corporation II Nov-28-2016
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