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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Advance	648	648
Patient-Device Incompatibility	139	139
Adverse Event Without Identified Device or Use Problem	125	125
Material Deformation	116	118
Improper or Incorrect Procedure or Method	99	99
Material Separation	84	84
Difficult to Advance	60	60
Device Dislodged or Dislocated	55	55
Difficult to Remove	53	53
Off-Label Use	46	46
Deformation Due to Compressive Stress	44	44
Activation Failure	29	29
Break	17	17
Material Split, Cut or Torn	16	16
Fracture	16	16
Positioning Failure	15	15
Migration	14	14
No Apparent Adverse Event	14	14
Activation, Positioning or Separation Problem	13	13
Defective Device	13	13
Mechanical Problem	8	8
Material Rupture	8	8
Difficult or Delayed Positioning	6	6
Therapy Delivered to Incorrect Body Area	5	5
Premature Activation	5	5
Positioning Problem	5	6
Use of Device Problem	4	4
Stretched	4	4
Deflation Problem	4	4
Insufficient Information	4	4
Unintended Movement	4	4
Leak/Splash	4	4
Difficult to Insert	3	4
Device Damaged by Another Device	3	4
Material Integrity Problem	3	3
Migration or Expulsion of Device	3	3
Entrapment of Device	3	4
Difficult or Delayed Activation	2	2
Material Twisted/Bent	2	2
Crack	2	2
Material Too Soft/Flexible	2	2
Failure to Deflate	2	2
Unstable	2	2
Failure to Deliver	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Wrong Label	1	1
Inflation Problem	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	934	937
Thrombosis/Thrombus	33	33
Angina	29	29
Insufficient Information	28	28
Myocardial Infarction	23	23
Stenosis	23	23
Obstruction/Occlusion	22	22
Cardiac Arrest	21	21
Perforation of Vessels	18	18
Pericardial Effusion	16	16
Perforation	13	13
Low Blood Pressure/ Hypotension	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/Bleeding	9	9
Ventricular Fibrillation	8	8
Restenosis	8	8
Ischemia	7	7
Dyspnea	7	7
Non specific EKG/ECG Changes	6	6
Pain	6	6
Tachycardia	6	6
Device Embedded In Tissue or Plaque	6	6
Unspecified Heart Problem	6	6
Swelling/ Edema	6	6
Embolism/Embolus	5	5
Heart Failure/Congestive Heart Failure	5	5
Cardiac Tamponade	5	5
Extravasation	5	5
Arrhythmia	5	5
Unspecified Tissue Injury	4	4
Atrial Fibrillation	3	3
Stroke/CVA	3	3
Cardiac Enzyme Elevation	3	3
Sepsis	3	3
Shock	2	2
Thrombosis	2	2
Vasoconstriction	2	2
Diaphoresis	2	2
Low Oxygen Saturation	2	2
No Patient Involvement	2	2
Hematoma	2	2
Bradycardia	2	2
Nausea	2	2
Pneumonia	2	2
Hypersensitivity/Allergic reaction	2	2
High Blood Pressure/ Hypertension	2	2