TPLC - Total Product Life Cycle

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Device	stent, iliac
Definition	Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
Product Code	NIO
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
21	12	15	16	12	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	400	400
Adverse Event Without Identified Device or Use Problem	301	301
Difficult to Remove	200	200
Off-Label Use	179	179
Activation Failure	172	172
Material Deformation	168	168
Difficult to Advance	146	146
Failure to Advance	142	142
Premature Activation	134	134
Improper or Incorrect Procedure or Method	114	114
Detachment of Device or Device Component	107	107
Break	88	88
Positioning Problem	86	86
Positioning Failure	85	85
Misfire	80	80
Fracture	67	67
Mechanical Jam	63	63
Migration	60	60
Difficult or Delayed Positioning	56	56
Activation, Positioning or Separation Problem	55	55
Material Separation	46	46
Entrapment of Device	40	40
Difficult or Delayed Activation	38	38
Physical Resistance/Sticking	33	33
Malposition of Device	32	32
Device-Device Incompatibility	30	30
Material Rupture	29	30
Stretched	28	28
Defective Device	22	22
Leak/Splash	22	22
Difficult to Insert	22	22
Insufficient Information	21	21
Deformation Due to Compressive Stress	21	21
Migration or Expulsion of Device	20	20
Patient-Device Incompatibility	19	19
Use of Device Problem	17	17
Material Split, Cut or Torn	16	16
Poor Visibility	14	14
Device Damaged by Another Device	14	14
Device Damaged Prior to Use	13	13
Material Integrity Problem	13	13
Burst Container or Vessel	12	12
Material Twisted/Bent	12	12
Obstruction of Flow	11	11
Material Frayed	10	10
Complete Blockage	10	10
Structural Problem	9	9
Premature Separation	9	9
Inflation Problem	9	9
Device Markings/Labelling Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1281	1284
No Consequences Or Impact To Patient	161	161
Obstruction/Occlusion	89	89
Insufficient Information	69	69
Foreign Body In Patient	63	63
Restenosis	56	56
Thrombosis/Thrombus	51	51
Stenosis	50	50
No Known Impact Or Consequence To Patient	49	49
Vascular Dissection	44	44
Device Embedded In Tissue or Plaque	41	41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	41	41
No Information	38	38
Occlusion	36	36
Ischemia	34	34
Death	33	33
Hematoma	28	28
Hemorrhage/Bleeding	25	25
Pain	25	25
Blood Loss	25	25
No Code Available	24	24
Unspecified Tissue Injury	20	20
Embolism/Embolus	20	20
No Patient Involvement	19	19
Unspecified Infection	18	18
Renal Failure	16	16
Aneurysm	15	15
Pseudoaneurysm	14	14
Thrombosis	14	14
Stroke/CVA	13	13
Rupture	10	10
Perforation of Vessels	10	10
Injury	10	10
Perforation	8	8
Myocardial Infarction	8	8
Thromboembolism	7	7
Reocclusion	6	6
Hypersensitivity/Allergic reaction	6	6
Embolism	6	6
High Blood Pressure/ Hypertension	5	5
Fistula	5	5
Valvular Stenosis	5	5
Vessel Or Plaque, Device Embedded In	4	4
Respiratory Failure	4	4
Low Blood Pressure/ Hypotension	4	4
Renal Impairment	4	4
Seroma	4	4
Failure of Implant	4	4
Dyspnea	4	4
Pneumonia	3	3