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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, removal, pacemaker electrode, percutaneous
Product CodeMFA
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
1 1 0 1 1 0

MDR Year MDR Reports MDR Events
2020 77 199
2021 83 3011
2022 60 60
2023 55 55
2024 70 70
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 299 2861
Material Separation 26 26
Break 18 384
Deformation Due to Compressive Stress 7 7
Entrapment of Device 3 3
Material Split, Cut or Torn 3 3
Material Puncture/Hole 2 2
Material Deformation 2 2
Mechanical Jam 2 2
Human-Device Interface Problem 1 1
Overheating of Device 1 123
Use of Device Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Great Vessel Perforation 231 2061
Perforation of Vessels 105 1813
Iatrogenic Source 73 317
Pericardial Effusion 68 678
Cardiac Perforation 65 431
Unintended Radiation Exposure 44 410
Death 26 148
Atrial Perforation 14 14
Pleural Effusion 12 134
Cardiac Tamponade 8 130
Radiation Exposure, Unintended 6 128
No Clinical Signs, Symptoms or Conditions 5 127
Hemorrhage/Bleeding 4 4
Hemothorax 4 4
No Known Impact Or Consequence To Patient 3 3
Laceration(s) 3 3
Vascular Dissection 2 124
Embolism/Embolus 2 124
Burning Sensation 2 124
Foreign Body Embolism 2 2
Stroke/CVA 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Mitral Perforation 1 1
Hematoma 1 123
Perforation 1 1
Obstruction/Occlusion 1 123
Low Cardiac Output 1 1
Thrombosis 1 1
Tricuspid Regurgitation 1 1
Pseudoaneurysm 1 1
Low Blood Pressure/ Hypotension 1 1
Embolus 1 1

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