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)
2020	2021	2022	2023	2024	2025
62	63	45	49	35	27

MDR Year	MDR Reports	MDR Events
2020	6362	6363
2021	5268	5270
2022	4068	4156
2023	3097	3099
2024	3041	3043
2025	2277	2278

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7909	7911
Material Deformation	6504	6504
Failure to Advance	4508	4508
Device Dislodged or Dislocated	3382	3383
Difficult to Remove	1715	1716
Break	1519	1521
Difficult to Advance	1033	1034
Positioning Problem	490	490
Improper or Incorrect Procedure or Method	456	457
Fracture	437	437
Material Rupture	433	435
Activation Failure	416	416
Inflation Problem	387	387
Detachment of Device or Device Component	360	360
Material Separation	351	351
Device Damaged by Another Device	324	324
Activation, Positioning or Separation Problem	273	273
Leak/Splash	269	269
Entrapment of Device	234	234
Deflation Problem	204	204
Obstruction of Flow	198	198
Deformation Due to Compressive Stress	180	180
Burst Container or Vessel	179	179
Device-Device Incompatibility	127	127
Patient-Device Incompatibility	118	206
Material Integrity Problem	114	114
Defective Device	113	113
Use of Device Problem	108	108
Material Split, Cut or Torn	107	107
Failure to Deflate	89	89
Migration	86	86
Positioning Failure	79	79
Stretched	77	77
Difficult to Insert	71	71
Migration or Expulsion of Device	60	60
Difficult or Delayed Activation	56	56
Patient Device Interaction Problem	53	53
Off-Label Use	51	51
Device Markings/Labelling Problem	37	37
Difficult or Delayed Positioning	36	36
Premature Activation	36	36
Device Contamination with Chemical or Other Material	30	30
Malposition of Device	29	29
Physical Resistance/Sticking	28	28
Contamination	28	28
Product Quality Problem	25	25
Component Missing	25	25
Insufficient Information	22	22
Difficult to Open or Remove Packaging Material	21	21
Material Twisted/Bent	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10920	10924
No Consequences Or Impact To Patient	3649	3649
Vascular Dissection	3194	3194
Myocardial Infarction	1429	1519
Insufficient Information	1200	1200
Thrombosis/Thrombus	869	959
Angina	804	804
Intimal Dissection	496	496
Death	444	444
Stenosis	435	435
Restenosis	422	422
Obstruction/Occlusion	396	397
Cardiac Arrest	329	329
Chest Pain	316	317
Thrombosis	306	306
Stroke/CVA	288	373
Device Embedded In Tissue or Plaque	285	285
Foreign Body In Patient	245	246
No Patient Involvement	208	208
Injury	198	198
Ischemia	195	195
Hemorrhage/Bleeding	191	191
No Known Impact Or Consequence To Patient	190	190
Unspecified Tissue Injury	178	178
Low Blood Pressure/ Hypotension	136	137
Non specific EKG/ECG Changes	136	136
Occlusion	130	130
Heart Failure/Congestive Heart Failure	119	119
No Code Available	116	116
Perforation of Vessels	113	113
Dyspnea	111	111
Perforation	95	95
Arteriosclerosis/ Atherosclerosis	95	95
Arrhythmia	82	82
Thrombus	79	79
Pain	78	78
Cardiac Enzyme Elevation	77	77
Ventricular Fibrillation	72	72
Cardiogenic Shock	71	71
Hematoma	62	62
Unspecified Heart Problem	61	61
Hypersensitivity/Allergic reaction	58	61
Bradycardia	54	54
Blood Loss	50	50
High Blood Pressure/ Hypertension	48	48
Prolapse	47	47
Aneurysm	46	46
Local Reaction	42	42
Embolism/Embolus	39	39
Atrial Fibrillation	38	38

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