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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Advance	733	733
Patient-Device Incompatibility	182	182
Material Deformation	178	178
Adverse Event Without Identified Device or Use Problem	164	164
Improper or Incorrect Procedure or Method	133	133
Device Dislodged or Dislocated	97	97
Material Separation	95	95
Difficult to Advance	65	65
Difficult to Remove	64	64
Off-Label Use	56	56
Deformation Due to Compressive Stress	47	47
Activation Failure	30	30
Break	28	28
Migration	21	21
Fracture	20	20
No Apparent Adverse Event	15	15
Positioning Failure	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
Difficult or Delayed Activation	7	7
Premature Activation	6	6
Positioning Problem	6	6
Device Damaged by Another Device	6	6
Use of Device Problem	6	6
Therapy Delivered to Incorrect Body Area	5	5
Detachment of Device or Device Component	5	5
Deflation Problem	5	5
Insufficient Information	5	5
Unintended Movement	5	5
Unstable	5	5
Stretched	4	4
Material Twisted/Bent	4	4
Difficult or Delayed Positioning	4	4
Product Quality Problem	4	4
Migration or Expulsion of Device	4	4
Entrapment of Device	4	4
Leak/Splash	4	4
Difficult to Insert	3	3
Component Missing	3	3
Material Integrity Problem	3	3
Malposition of Device	3	3
Inflation Problem	2	2
Crack	2	2
Material Too Soft/Flexible	2	2
Device-Device Incompatibility	2	2
Failure to Deliver	1	1
Failure to Fold	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	847	847
No Consequences Or Impact To Patient	299	299
Cardiac Arrest	41	41
Stenosis	40	40
Death	39	39
Angina	36	36
Thrombosis/Thrombus	30	30
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
Obstruction/Occlusion	18	18
Pericardial Effusion	18	18
Perforation of Vessels	16	16
Cardiac Tamponade	14	14
Hemorrhage/Bleeding	12	12
Thrombosis	12	12
Ventricular Fibrillation	11	11
Cardiogenic Shock	11	11
Pulmonary Edema	10	10
Ischemia	10	10
No Code Available	9	9
Vascular Dissection	8	8
Occlusion	7	7
Device Embedded In Tissue or Plaque	7	7
Restenosis	7	7
Dyspnea	6	6
Tachycardia	6	6
Swelling/ Edema	6	6
Non specific EKG/ECG Changes	6	6
Pain	5	5
Extravasation	5	5
Intimal Dissection	5	5
Unspecified Tissue Injury	4	4
Arrhythmia	4	4
Injury	4	4
Bradycardia	3	3
Unspecified Heart Problem	3	3
Cardiac Enzyme Elevation	3	3
Respiratory Failure	3	3
No Known Impact Or Consequence To Patient	3	3
Atrial Fibrillation	3	3
Embolism/Embolus	3	3
Hematoma	3	3
Inflammation	2	2
Vessel Or Plaque, Device Embedded In	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Low Oxygen Saturation	2	2