TPLC - Total Product Life Cycle

• Device: coronary drug-eluting stent
• Definition: Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
• Product Code: NIQ
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
59	62	63	45	49	23

MDR Year	MDR Reports	MDR Events
2019	7254	7254
2020	6362	6362
2021	5268	5268
2022	4068	4153
2023	3097	3097
2024	2041	2041

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	9159	9159
Material Deformation	8029	8029
Failure to Advance	5206	5206
Device Dislodged or Dislocated	3542	3542
Difficult to Remove	1811	1811
Break	1625	1625
Difficult to Advance	1111	1111
Improper or Incorrect Procedure or Method	483	483
Material Separation	427	427
Fracture	416	416
Material Rupture	411	411
Inflation Problem	398	398
Activation Failure	393	393
Detachment of Device or Device Component	334	334
Device Damaged by Another Device	316	316
Positioning Problem	283	283
Obstruction of Flow	267	267
Deflation Problem	251	251
Activation, Positioning or Separation Problem	244	244
Entrapment of Device	241	241
Leak/Splash	232	232
Burst Container or Vessel	161	161
Patient-Device Incompatibility	151	236
Device-Device Incompatibility	142	142
Defective Device	124	124
Deformation Due to Compressive Stress	121	121
Material Integrity Problem	117	117
Use of Device Problem	103	103
Migration	98	98
Material Split, Cut or Torn	87	87
Positioning Failure	71	71
Stretched	67	67
Difficult to Insert	67	67
Difficult or Delayed Activation	65	65
Failure to Deflate	55	55
Migration or Expulsion of Device	54	54
Patient Device Interaction Problem	52	52
Off-Label Use	46	46
Difficult or Delayed Positioning	41	41
Device Markings/Labelling Problem	38	38
Malposition of Device	36	36
Premature Activation	34	34
Physical Resistance/Sticking	33	33
Device Contamination with Chemical or Other Material	32	32
Contamination	30	30
Insufficient Information	28	28
Product Quality Problem	28	28
Component Missing	25	25
Material Puncture/Hole	21	21
Packaging Problem	20	20

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9226	9226
No Consequences Or Impact To Patient	7510	7510
Vascular Dissection	2710	2710
Myocardial Infarction	2103	2188
Insufficient Information	996	996
Intimal Dissection	995	995
Angina	919	919
Death	803	803
Thrombosis/Thrombus	690	775
Thrombosis	540	540
Stenosis	532	532
No Patient Involvement	416	416
No Known Impact Or Consequence To Patient	392	392
Occlusion	378	378
Injury	376	376
Stroke/CVA	363	448
Obstruction/Occlusion	310	310
Restenosis	305	305
Cardiac Arrest	293	293
Chest Pain	284	284
Thrombus	243	243
No Code Available	228	228
Foreign Body In Patient	224	224
Device Embedded In Tissue or Plaque	220	220
Blood Loss	191	191
Unspecified Tissue Injury	169	169
Ischemia	161	161
Hemorrhage/Bleeding	142	142
Low Blood Pressure/ Hypotension	133	133
Non specific EKG/ECG Changes	131	131
Dyspnea	119	119
Perforation	118	118
Cardiac Enzyme Elevation	93	93
Arteriosclerosis/ Atherosclerosis	82	82
Perforation of Vessels	80	80
Heart Failure/Congestive Heart Failure	79	79
Reocclusion	77	77
Arrhythmia	70	70
Hypersensitivity/Allergic reaction	67	67
Cardiogenic Shock	65	65
Ventricular Fibrillation	64	64
Bradycardia	64	64
Prolapse	62	62
High Blood Pressure/ Hypertension	60	60
Pain	56	56
Embolism	51	51
Patient Problem/Medical Problem	50	50
Heart Failure	48	48
Aneurysm	44	44
Local Reaction	41	41

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular	II	Jun-15-2020