TPLC - Total Product Life Cycle

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Device	stent, coronary
Definition	The formerly known device, Cardiovascular Stent, coded as "MAF" has been modified and is currently known and classified as a "Coronary Stent". This device is a metal scaffold placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen.
Product Code	MAF
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
13	8	8	3	2	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Advance	644	644
Patient-Device Incompatibility	139	139
Adverse Event Without Identified Device or Use Problem	129	129
Material Deformation	113	115
Improper or Incorrect Procedure or Method	101	101
Material Separation	84	84
Difficult to Advance	59	59
Difficult to Remove	55	55
Device Dislodged or Dislocated	54	54
Off-Label Use	47	47
Deformation Due to Compressive Stress	45	45
Activation Failure	31	31
Break	18	18
Material Split, Cut or Torn	16	16
Fracture	16	16
Positioning Failure	15	15
Activation, Positioning or Separation Problem	14	14
Migration	14	14
No Apparent Adverse Event	14	14
Defective Device	13	13
Mechanical Problem	8	8
Material Rupture	8	8
Premature Activation	6	6
Difficult or Delayed Positioning	6	6
Therapy Delivered to Incorrect Body Area	5	5
Positioning Problem	5	6
Insufficient Device Problem Information	4	4
Use of Device Problem	4	4
Stretched	4	4
Deflation Problem	4	4
Unintended Movement	4	4
Leak/Splash	4	4
Device Damaged by Another Device	3	4
Difficult to Insert	3	4
Material Integrity Problem	3	3
Entrapment of Device	3	4
Difficult or Delayed Activation	2	2
Material Twisted/Bent	2	2
Crack	2	2
Migration or Expulsion of Device	2	2
Material Too Soft/Flexible	2	2
Failure to Deflate	2	2
Unstable	2	2
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Inflation Problem	1	1
Wrong Label	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	941	944
Thrombosis/Thrombus	33	33
Angina	29	29
Insufficient Information	28	28
Stenosis	25	25
Myocardial Infarction	23	23
Obstruction/Occlusion	23	23
Cardiac Arrest	21	21
Perforation of Vessels	18	18
Pericardial Effusion	16	16
Low Blood Pressure/ Hypotension	13	13
Perforation	13	13
No Consequences Or Impact To Patient	12	12
Cardiogenic Shock	11	11
Foreign Body In Patient	11	11
Vascular Dissection	10	10
Pulmonary Edema	9	9
Hemorrhage/Blood Loss/Bleeding	9	9
Ischemia	8	8
Restenosis	8	8
Dyspnea	8	8
Ventricular Fibrillation	8	8
Non specific EKG/ECG Changes	6	6
Unspecified Heart Problem	6	6
Swelling/ Edema	6	6
Tachycardia	6	6
Pain	6	6
Device Embedded In Tissue or Plaque	6	6
Arrhythmia	5	5
Stroke/CVA	5	5
Extravasation	5	5
Heart Failure/Congestive Heart Failure	5	5
Embolism/Embolus	5	5
Cardiac Tamponade	5	5
Unspecified Tissue Injury	4	4
Cardiac Enzyme Elevation	3	3
Atrial Fibrillation	3	3
Sepsis	3	3
Chest Pain	2	2
Thrombosis	2	2
No Patient Involvement	2	2
Low Oxygen Saturation	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Vasoconstriction	2	2
Inflammation	2	2
Bradycardia	2	2
Pneumonia	2	2
Hematoma	2	2
Shock	2	2
Diaphoresis	2	2