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	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	935	935
Activation Failure	818	818
Material Deformation	433	433
Break	418	418
Material Separation	403	403
Fracture	352	352
Difficult to Remove	320	320
Activation, Positioning or Separation Problem	284	284
Premature Activation	277	277
Detachment of Device or Device Component	257	257
Stretched	204	204
Difficult or Delayed Activation	198	198
Improper or Incorrect Procedure or Method	192	192
Mechanical Jam	188	188
Difficult to Advance	159	159
Failure to Advance	147	147
Physical Resistance/Sticking	125	125
Positioning Failure	115	115
Malposition of Device	103	103
Obstruction of Flow	102	102
Migration	91	91
Material Twisted/Bent	89	89
Entrapment of Device	72	72
Complete Blockage	70	70
Patient-Device Incompatibility	65	65
Misfire	63	63
Defective Device	63	63
Difficult or Delayed Positioning	62	62
Positioning Problem	62	62
Insufficient Information	58	58
Device Dislodged or Dislocated	51	51
Device Stenosis	49	49
Deformation Due to Compressive Stress	36	36
Activation Problem	32	32
Device Damaged by Another Device	27	27
Off-Label Use	26	26
Use of Device Problem	23	23
Partial Blockage	23	23
Separation Failure	22	22
Device-Device Incompatibility	22	22
Difficult to Insert	20	20
Material Split, Cut or Torn	17	17
Loss of or Failure to Bond	16	16
Device Markings/Labelling Problem	16	16
Material Fragmentation	15	15
Noise, Audible	14	14
Separation Problem	13	13
Failure to Eject	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	2305	2305
No Consequences Or Impact To Patient	412	412
Restenosis	381	381
Obstruction/Occlusion	338	338
Pain	230	230
Thrombosis/Thrombus	214	214
Stenosis	170	170
Foreign Body In Patient	156	156
Insufficient Information	151	151
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	80	80
Ischemia	72	72
Occlusion	67	67
Device Embedded In Tissue or Plaque	66	66
Vascular Dissection	56	56
Reocclusion	46	46
Unspecified Infection	43	43
Pseudoaneurysm	39	39
Hemorrhage/Bleeding	33	33
Embolism/Embolus	31	31
Aneurysm	30	30
No Known Impact Or Consequence To Patient	29	29
Perforation of Vessels	29	29
Unspecified Tissue Injury	28	28
Thrombosis	27	27
Hematoma	24	24
Injury	23	23
Claudication	22	22
Death	21	21
Perforation	20	20
No Code Available	20	20
Stroke/CVA	20	20
No Patient Involvement	19	19
Unspecified Vascular Problem	18	18
Myocardial Infarction	18	18
Failure of Implant	16	16
Swelling/ Edema	14	14
Bacterial Infection	11	11
Renal Failure	11	11
Discomfort	10	10
Tissue Breakdown	9	9
Embolism	9	9
Skin Discoloration	9	9
Ischemia Stroke	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Arteriosclerosis/ Atherosclerosis	8	8
Numbness	7	7
Thrombocytopenia	7	7
Thrombus	7	7
Rupture	7	7
Intimal Dissection	7	7