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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Advance	756	756
Patient-Device Incompatibility	186	186
Material Deformation	179	179
Adverse Event Without Identified Device or Use Problem	165	165
Improper or Incorrect Procedure or Method	134	134
Device Dislodged or Dislocated	98	98
Material Separation	98	98
Difficult to Advance	67	67
Difficult to Remove	66	66
Off-Label Use	58	58
Deformation Due to Compressive Stress	49	49
Activation Failure	30	30
Break	28	28
Migration	21	21
Fracture	20	20
Positioning Failure	16	16
No Apparent Adverse Event	15	15
Activation, Positioning or Separation Problem	14	14
Material Split, Cut or Torn	14	14
Defective Device	14	14
Material Rupture	12	12
Mechanical Problem	10	10
Premature Activation	7	7
Difficult or Delayed Activation	7	7
Positioning Problem	6	6
Use of Device Problem	6	6
Device Damaged by Another Device	6	6
Difficult or Delayed Positioning	6	6
Deflation Problem	5	5
Insufficient Information	5	5
Therapy Delivered to Incorrect Body Area	5	5
Unintended Movement	5	5
Unstable	5	5
Detachment of Device or Device Component	5	5
Stretched	4	4
Leak/Splash	4	4
Material Twisted/Bent	4	4
Product Quality Problem	4	4
Entrapment of Device	4	4
Migration or Expulsion of Device	4	4
Material Integrity Problem	3	3
Difficult to Insert	3	3
Component Missing	3	3
Malposition of Device	3	3
Inflation Problem	2	2
Material Too Soft/Flexible	2	2
Crack	2	2
Device-Device Incompatibility	2	2
Fluid/Blood Leak	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	878	878
No Consequences Or Impact To Patient	299	299
Cardiac Arrest	41	41
Stenosis	40	40
Death	39	39
Angina	36	36
Thrombosis/Thrombus	31	31
Myocardial Infarction	25	25
Insufficient Information	24	24
Perforation	24	24
No Patient Involvement	22	22
Foreign Body In Patient	21	21
Low Blood Pressure/ Hypotension	20	20
Pericardial Effusion	18	18
Obstruction/Occlusion	18	18
Perforation of Vessels	18	18
Cardiac Tamponade	15	15
Hemorrhage/Bleeding	13	13
Thrombosis	12	12
Cardiogenic Shock	11	11
Ventricular Fibrillation	11	11
Ischemia	10	10
Pulmonary Edema	10	10
Vascular Dissection	9	9
No Code Available	9	9
Occlusion	7	7
Device Embedded In Tissue or Plaque	7	7
Restenosis	7	7
Tachycardia	6	6
Swelling/ Edema	6	6
Dyspnea	6	6
Non specific EKG/ECG Changes	6	6
Extravasation	5	5
Pain	5	5
Intimal Dissection	5	5
Unspecified Tissue Injury	4	4
Shock	4	4
Embolism/Embolus	4	4
Arrhythmia	4	4
Injury	4	4
Bradycardia	3	3
No Known Impact Or Consequence To Patient	3	3
Atrial Fibrillation	3	3
Hematoma	3	3
Unspecified Heart Problem	3	3
Cardiac Enzyme Elevation	3	3
Respiratory Failure	3	3
Pneumonia	2	2
Heart Failure/Congestive Heart Failure	2	2
Low Oxygen Saturation	2	2