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)
2020	2021	2022	2023	2024	2025
21	13	8	8	3	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Advance	817	817
Patient-Device Incompatibility	188	188
Material Deformation	184	186
Adverse Event Without Identified Device or Use Problem	173	173
Improper or Incorrect Procedure or Method	138	138
Device Dislodged or Dislocated	107	107
Material Separation	105	105
Difficult to Advance	74	74
Difficult to Remove	69	69
Off-Label Use	64	64
Deformation Due to Compressive Stress	53	53
Activation Failure	33	33
Break	30	30
Migration	21	21
Fracture	20	20
Material Split, Cut or Torn	18	18
Positioning Failure	17	17
Defective Device	16	16
No Apparent Adverse Event	15	15
Activation, Positioning or Separation Problem	14	14
Material Rupture	12	12
Mechanical Problem	10	10
Premature Activation	7	7
Difficult or Delayed Activation	7	7
Positioning Problem	6	7
Insufficient Information	6	6
Use of Device Problem	6	6
Device Damaged by Another Device	6	7
Difficult or Delayed Positioning	6	6
Deflation Problem	5	5
Therapy Delivered to Incorrect Body Area	5	5
Unintended Movement	5	5
Leak/Splash	5	5
Unstable	5	5
Detachment of Device or Device Component	5	5
Entrapment of Device	5	6
Stretched	4	4
Material Twisted/Bent	4	4
Product Quality Problem	4	4
Migration or Expulsion of Device	4	4
Material Integrity Problem	3	3
Difficult to Insert	3	4
Component Missing	3	3
Material Too Soft/Flexible	3	3
Malposition of Device	3	3
Inflation Problem	2	2
Failure to Deflate	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Physical Resistance/Sticking	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	952	955
No Consequences Or Impact To Patient	299	299
Cardiac Arrest	42	42
Stenosis	42	42
Death	39	39
Angina	38	38
Thrombosis/Thrombus	33	33
Myocardial Infarction	28	28
Insufficient Information	27	27
Perforation	25	25
No Patient Involvement	22	22
Foreign Body In Patient	21	21
Obstruction/Occlusion	21	21
Low Blood Pressure/ Hypotension	20	20
Pericardial Effusion	19	19
Perforation of Vessels	17	17
Cardiac Tamponade	14	14
Hemorrhage/Bleeding	14	14
Thrombosis	12	12
Cardiogenic Shock	12	12
Ventricular Fibrillation	11	11
Pulmonary Edema	10	10
Vascular Dissection	10	10
Ischemia	10	10
Device Embedded In Tissue or Plaque	9	9
No Code Available	9	9
Dyspnea	8	8
Restenosis	8	8
Occlusion	7	7
Tachycardia	6	6
Non specific EKG/ECG Changes	6	6
Swelling/ Edema	6	6
Pain	5	5
Embolism/Embolus	5	5
Intimal Dissection	5	5
Heart Failure/Congestive Heart Failure	5	5
Arrhythmia	5	5
Extravasation	5	5
Shock	4	4
Unspecified Tissue Injury	4	4
Injury	4	4
Unspecified Heart Problem	3	3
Bradycardia	3	3
Cardiac Enzyme Elevation	3	3
No Known Impact Or Consequence To Patient	3	3
Respiratory Failure	3	3
Atrial Fibrillation	3	3
Hematoma	3	3
Stroke/CVA	3	3
Inflammation	2	2