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)
2021	2022	2023	2024	2025	2026
26	26	27	29	34	19

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	1018	1018
Adverse Event Without Identified Device or Use Problem	898	910
Break	464	464
Material Deformation	445	445
Material Separation	422	423
Fracture	346	349
Detachment of Device or Device Component	313	316
Difficult to Remove	310	310
Activation, Positioning or Separation Problem	275	277
Premature Activation	260	262
Stretched	213	214
Difficult or Delayed Activation	193	194
Improper or Incorrect Procedure or Method	179	181
Failure to Advance	161	161
Difficult to Advance	155	156
Mechanical Jam	149	150
Physical Resistance/Sticking	123	123
Positioning Failure	113	113
Obstruction of Flow	108	108
Material Twisted/Bent	101	101
Malposition of Device	98	98
Migration	93	95
Device Stenosis	74	76
Difficult or Delayed Positioning	68	68
Insufficient Device Problem Information	68	68
Complete Blockage	68	72
Misfire	67	67
Entrapment of Device	59	59
Patient-Device Incompatibility	59	63
Deformation Due to Compressive Stress	53	53
Defective Device	52	52
Device Dislodged or Dislocated	47	48
Positioning Problem	43	43
Loss of or Failure to Bond	37	38
Activation Problem	35	35
Material Fragmentation	28	28
Use of Device Problem	27	27
Separation Failure	27	27
Off-Label Use	26	26
Device Damaged by Another Device	24	24
Device Endoleak	23	24
Difficult to Insert	22	22
Device-Device Incompatibility	22	22
Material Split, Cut or Torn	20	20
Separation Problem	19	20
Device Markings/Labelling Problem	18	18
Partial Blockage	17	17
Difficult or Delayed Separation	14	14
Patient Device Interaction Problem	13	15
No Apparent Adverse Event	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2977	2984
Obstruction/Occlusion	396	406
Restenosis	377	377
Thrombosis/Thrombus	258	263
Pain	247	247
Insufficient Information	195	196
Stenosis	187	189
Foreign Body In Patient	173	174
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	83	83
Ischemia	77	78
Vascular Dissection	58	59
Device Embedded In Tissue or Plaque	57	57
Clinical Endoleak	49	52
Unspecified Infection	47	47
Pseudoaneurysm	41	41
Hemorrhage/Blood Loss/Bleeding	38	40
Perforation of Vessels	35	36
Embolism/Embolus	31	32
Unspecified Tissue Injury	30	30
Aneurysm	26	26
Hematoma	25	25
Stroke/CVA	23	29
Unspecified Vascular Problem	23	23
Reduced Blood Flow	21	21
No Consequences Or Impact To Patient	20	20
Failure of Implant	19	20
Myocardial Infarction	16	16
Swelling/ Edema	14	14
Ischemia Stroke	12	12
Bacterial Infection	12	12
Discomfort	11	11
Renal Impairment	9	9
Renal Failure	9	11
Skin Discoloration	9	9
Rupture	9	9
Tissue Breakdown	9	9
Cramp(s) /Muscle Spasm(s)	8	8
Arteriosclerosis/ Atherosclerosis	7	7
Thrombocytopenia	7	7
Numbness	7	7
Foreign Body Embolism	7	7
Necrosis	6	6
Aneurysm expansion	6	6
Cardiac Arrest	6	6
Ruptured Aneurysm	6	6
Unspecified Heart Problem	6	6
Perforation	6	6
Calcium Deposits/Calcification	6	6
Pallor	5	5
Thromboembolism	5	5