TPLC - Total Product Life Cycle

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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)
2019	2020	2021	2022	2023	2024
46	33	26	26	27	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1032	1032
Activation Failure	744	744
Material Separation	476	476
Material Deformation	464	464
Break	405	405
Difficult to Remove	364	364
Fracture	361	361
Activation, Positioning or Separation Problem	301	301
Premature Activation	295	295
Difficult or Delayed Activation	239	239
Improper or Incorrect Procedure or Method	235	235
Detachment of Device or Device Component	229	229
Stretched	228	228
Mechanical Jam	194	194
Difficult to Advance	180	180
Failure to Advance	145	145
Physical Resistance/Sticking	141	141
Positioning Failure	126	126
Malposition of Device	108	108
Obstruction of Flow	103	103
Migration	102	102
Material Twisted/Bent	89	89
Entrapment of Device	87	87
Positioning Problem	77	77
Patient-Device Incompatibility	76	76
Misfire	75	75
Defective Device	69	69
Complete Blockage	68	68
Difficult or Delayed Positioning	62	62
Insufficient Information	53	53
Device Dislodged or Dislocated	53	53
Deformation Due to Compressive Stress	38	38
Device Damaged by Another Device	36	36
Activation Problem	35	35
Device Stenosis	34	34
Off-Label Use	31	31
Device-Device Incompatibility	24	24
Use of Device Problem	23	23
Partial Blockage	22	22
Difficult to Insert	22	22
Separation Failure	21	21
Tear, Rip or Hole in Device Packaging	19	19
Material Split, Cut or Torn	17	17
Device Markings/Labelling Problem	16	16
Noise, Audible	14	14
Material Integrity Problem	14	14
Loss of or Failure to Bond	13	13
Failure to Eject	13	13
Patient Device Interaction Problem	12	12
Material Fragmentation	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1972	1972
No Consequences Or Impact To Patient	761	761
Restenosis	331	331
Obstruction/Occlusion	303	303
Pain	224	224
Thrombosis/Thrombus	175	175
Reocclusion	166	166
Stenosis	164	164
Foreign Body In Patient	158	158
Claudication	148	148
Insufficient Information	140	140
Occlusion	105	105
Device Embedded In Tissue or Plaque	83	83
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	77	77
Ischemia	72	72
Thrombosis	63	63
No Patient Involvement	57	57
Vascular Dissection	56	56
No Known Impact Or Consequence To Patient	48	48
Unspecified Infection	46	46
Injury	39	39
Pseudoaneurysm	36	36
Hemorrhage/Bleeding	33	33
Death	31	31
Patient Problem/Medical Problem	30	30
No Code Available	29	29
Embolism/Embolus	28	28
Unspecified Tissue Injury	28	28
Aneurysm	28	28
Hematoma	27	27
Perforation	25	25
Perforation of Vessels	25	25
Stroke/CVA	19	19
Myocardial Infarction	17	17
Failure of Implant	16	16
Unspecified Vascular Problem	16	16
Embolism	16	16
Renal Failure	13	13
Vessel Or Plaque, Device Embedded In	13	13
Bacterial Infection	11	11
Swelling/ Edema	11	11
Thrombus	11	11
Numbness	10	10
Intimal Dissection	9	9
Discomfort	9	9
Tissue Breakdown	9	9
Sepsis	8	8
Arteriosclerosis/ Atherosclerosis	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Rupture	7	7