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)
2020	2021	2022	2023	2024	2025
33	26	26	27	29	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	921	921
Activation Failure	767	767
Material Deformation	416	416
Material Separation	396	396
Break	395	395
Fracture	340	340
Difficult to Remove	314	314
Activation, Positioning or Separation Problem	277	277
Premature Activation	274	274
Detachment of Device or Device Component	241	241
Stretched	202	202
Difficult or Delayed Activation	197	197
Improper or Incorrect Procedure or Method	191	191
Mechanical Jam	186	186
Difficult to Advance	156	156
Failure to Advance	139	139
Physical Resistance/Sticking	123	123
Positioning Failure	109	109
Malposition of Device	101	101
Obstruction of Flow	100	100
Migration	89	89
Material Twisted/Bent	84	84
Entrapment of Device	71	71
Complete Blockage	70	70
Patient-Device Incompatibility	65	65
Misfire	63	63
Defective Device	63	63
Positioning Problem	62	62
Difficult or Delayed Positioning	59	59
Insufficient Information	57	57
Device Dislodged or Dislocated	50	50
Device Stenosis	42	42
Deformation Due to Compressive Stress	34	34
Activation Problem	32	32
Device Damaged by Another Device	27	27
Off-Label Use	25	25
Partial Blockage	23	23
Use of Device Problem	23	23
Device-Device Incompatibility	22	22
Separation Failure	21	21
Difficult to Insert	20	20
Material Split, Cut or Torn	17	17
Device Markings/Labelling Problem	16	16
Loss of or Failure to Bond	15	15
Material Fragmentation	14	14
Noise, Audible	14	14
Failure to Eject	13	13
Separation Problem	13	13
Material Integrity Problem	12	12
Difficult or Delayed Separation	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2198	2198
No Consequences Or Impact To Patient	412	412
Restenosis	375	375
Obstruction/Occlusion	332	332
Pain	227	227
Thrombosis/Thrombus	207	207
Stenosis	168	168
Foreign Body In Patient	152	152
Insufficient Information	149	149
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	79	79
Ischemia	72	72
Occlusion	67	67
Device Embedded In Tissue or Plaque	66	66
Vascular Dissection	56	56
Reocclusion	46	46
Unspecified Infection	41	41
Pseudoaneurysm	36	36
Hemorrhage/Bleeding	33	33
Embolism/Embolus	31	31
Aneurysm	30	30
No Known Impact Or Consequence To Patient	29	29
Perforation of Vessels	28	28
Unspecified Tissue Injury	28	28
Thrombosis	27	27
Injury	23	23
Hematoma	23	23
Claudication	22	22
Death	21	21
No Code Available	20	20
Perforation	20	20
Stroke/CVA	20	20
No Patient Involvement	19	19
Unspecified Vascular Problem	18	18
Failure of Implant	16	16
Myocardial Infarction	16	16
Swelling/ Edema	13	13
Bacterial Infection	11	11
Renal Failure	11	11
Discomfort	9	9
Skin Discoloration	9	9
Embolism	9	9
Tissue Breakdown	9	9
Cramp(s) /Muscle Spasm(s)	8	8
Arteriosclerosis/ Atherosclerosis	8	8
Ischemia Stroke	8	8
Rupture	7	7
Thrombocytopenia	7	7
Intimal Dissection	7	7
Numbness	7	7
Thrombus	7	7