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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
88	82	97	167	99	128	45	72	53	61	59	62	63	45	49	23

MDR Year	MDR Reports	MDR Events
2014	6664	6664
2015	6142	6142
2016	7233	7233
2017	6786	6786
2018	6817	6817
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	18747	18747
Material Deformation	11437	11437
Failure to Advance	11072	11072
Device Dislodged or Dislocated	7629	7629
Bent	5450	5450
Difficult to Remove	3763	3763
Break	2902	2902
Occlusion Within Device	2281	2281
Difficult to Advance	1327	1327
Improper or Incorrect Procedure or Method	1247	1247
Device Damaged Prior to Use	1146	1146
Detachment Of Device Component	1075	1075
Device Damaged by Another Device	1067	1067
Inflation Problem	860	860
Material Rupture	825	825
Fracture	760	760
Activation, Positioning or Separation Problem	734	734
Leak/Splash	515	515
Deflation Problem	497	497
Material Separation	494	494
Difficult To Position	481	481
Detachment of Device or Device Component	455	455
Kinked	455	455
Entrapment of Device	450	450
Activation Failure	425	425
Obstruction of Flow	370	370
Positioning Problem	307	307
Difficult or Delayed Positioning	301	301
Burst Container or Vessel	254	254
Migration or Expulsion of Device	217	217
Positioning Failure	217	217
Physical Resistance	207	207
Defective Device	173	173
Patient-Device Incompatibility	173	258
Device-Device Incompatibility	149	149
Deformation Due to Compressive Stress	147	147
Device Expiration Issue	137	137
Material Integrity Problem	135	135
Stretched	130	130
Material Twisted/Bent	116	116
Use of Device Problem	111	111
Difficult to Insert	111	111
Migration	111	111
Unstable	108	108
Malposition of Device	93	93
Material Split, Cut or Torn	92	92
Device Contamination with Chemical or Other Material	90	90
Insufficient Information	89	89
Torn Material	87	87
Physical Resistance/Sticking	84	84

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	24712	24713
No Clinical Signs, Symptoms or Conditions	9226	9226
Myocardial Infarction	4268	4354
Intimal Dissection	3877	3877
Death	3278	3278
Vascular Dissection	2850	2850
Angina	2774	2774
No Patient Involvement	2663	2663
Thrombosis	2447	2447
Reocclusion	1475	1475
Stenosis	1457	1457
Chest Pain	1283	1283
No Known Impact Or Consequence To Patient	1096	1098
Occlusion	1073	1073
Insufficient Information	998	998
Cardiac Arrest	699	699
Thrombus	696	696
Dyspnea	694	694
Stroke/CVA	692	777
Thrombosis/Thrombus	690	775
Patient Problem/Medical Problem	659	659
Cardiac Enzyme Elevation	610	610
Obstruction/Occlusion	549	549
Foreign Body In Patient	464	464
Device Embedded In Tissue or Plaque	419	419
Blood Loss	413	413
Non specific EKG/ECG Changes	391	391
Injury	389	389
No Code Available	381	381
Ischemia	370	370
Low Blood Pressure/ Hypotension	366	366
Restenosis	307	307
ST Segment Elevation	297	297
Perforation	258	258
Hypersensitivity/Allergic reaction	217	217
Ventricular Fibrillation	194	194
Bradycardia	193	193
Hemorrhage/Bleeding	186	186
Heart Failure	183	184
Cardiogenic Shock	180	180
Arrhythmia	175	175
Unspecified Tissue Injury	169	169
Nausea	164	164
Vessel Or Plaque, Device Embedded In	162	162
Perforation of Vessels	152	152
Pain	135	135
High Blood Pressure/ Hypertension	133	133
Reaction	130	130
Congestive Heart Failure	119	119
Ventricular Tachycardia	117	117

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular	II	Jun-15-2020
2	Medtronic Vascular Galway Limited	II	Aug-21-2009
3	Medtronic Vascular, Inc.	II	Nov-05-2013