TPLC - Total Product Life Cycle

show TPLC since

Device	stent, superficial femoral artery
Definition	Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Product Code	NIP
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
26	26	27	29	34	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	903	903
Adverse Event Without Identified Device or Use Problem	864	876
Break	444	444
Material Deformation	419	419
Material Separation	374	376
Fracture	336	340
Difficult to Remove	288	289
Detachment of Device or Device Component	269	271
Activation, Positioning or Separation Problem	264	266
Premature Activation	251	253
Stretched	191	192
Difficult or Delayed Activation	181	182
Improper or Incorrect Procedure or Method	167	169
Failure to Advance	152	152
Mechanical Jam	149	150
Difficult to Advance	143	144
Physical Resistance/Sticking	114	114
Positioning Failure	106	106
Obstruction of Flow	105	105
Material Twisted/Bent	98	98
Malposition of Device	95	95
Migration	85	87
Device Stenosis	66	68
Complete Blockage	66	70
Insufficient Information	66	66
Difficult or Delayed Positioning	64	64
Entrapment of Device	63	63
Misfire	62	62
Patient-Device Incompatibility	55	59
Defective Device	53	53
Device Dislodged or Dislocated	51	52
Deformation Due to Compressive Stress	46	46
Positioning Problem	41	41
Activation Problem	37	37
Separation Failure	28	28
Material Fragmentation	26	26
Off-Label Use	25	25
Use of Device Problem	24	24
Device Damaged by Another Device	23	23
Difficult to Insert	22	22
Device-Device Incompatibility	19	19
Device Markings/Labelling Problem	18	18
Separation Problem	18	19
Material Split, Cut or Torn	18	18
Loss of or Failure to Bond	18	18
Partial Blockage	17	17
Patient Device Interaction Problem	13	15
Difficult or Delayed Separation	13	13
Leak/Splash	11	11
Noise, Audible	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2734	2741
Obstruction/Occlusion	377	387
Restenosis	367	367
Thrombosis/Thrombus	246	251
Pain	244	244
Insufficient Information	179	180
Stenosis	172	174
Foreign Body In Patient	156	157
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	81	81
Ischemia	72	73
Device Embedded In Tissue or Plaque	54	54
Vascular Dissection	54	55
Unspecified Infection	46	46
Pseudoaneurysm	39	39
Hemorrhage/Bleeding	36	38
Perforation of Vessels	34	35
Embolism/Embolus	31	32
Unspecified Tissue Injury	29	29
Aneurysm	24	24
Hematoma	22	22
Unspecified Vascular Problem	21	21
No Consequences Or Impact To Patient	20	20
Stroke/CVA	20	26
Failure of Implant	18	19
Myocardial Infarction	16	16
Swelling/ Edema	14	14
Bacterial Infection	11	11
Discomfort	10	10
Skin Discoloration	9	9
Tissue Breakdown	9	9
Ischemia Stroke	9	9
Renal Impairment	9	9
Renal Failure	9	11
Cramp(s) /Muscle Spasm(s)	8	8
Perforation	7	7
Numbness	7	7
Thrombocytopenia	7	7
Arteriosclerosis/ Atherosclerosis	7	7
Unspecified Heart Problem	6	6
Necrosis	6	6
Rupture	6	6
Ruptured Aneurysm	6	6
Cardiac Arrest	6	6
Calcium Deposits/Calcification	6	6
Foreign Body Embolism	5	5
Abscess	5	5
Hypersensitivity/Allergic reaction	5	5
Impaired Healing	5	5
Pallor	5	5
Dyspnea	4	4