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)
2021	2022	2023	2024	2025	2026
12	15	16	12	14	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	442	442
Adverse Event Without Identified Device or Use Problem	363	363
Activation Failure	342	348
Difficult to Remove	225	227
Material Deformation	204	205
Difficult to Advance	195	197
Premature Activation	192	197
Mechanical Jam	190	194
Off-Label Use	186	188
Improper or Incorrect Procedure or Method	173	175
Failure to Advance	171	173
Detachment of Device or Device Component	117	117
Break	114	115
Difficult or Delayed Activation	99	99
Material Separation	97	104
Positioning Failure	93	93
Physical Resistance/Sticking	83	83
Misfire	82	82
Positioning Problem	77	77
Migration	65	65
Difficult or Delayed Positioning	60	60
Fracture	59	60
Stretched	54	54
Entrapment of Device	48	48
Activation, Positioning or Separation Problem	44	44
Material Rupture	31	33
Malposition of Device	30	30
Device-Device Incompatibility	28	29
Deformation Due to Compressive Stress	27	27
Difficult to Insert	26	27
Defective Device	23	23
Device Damaged by Another Device	20	20
Use of Device Problem	20	20
Material Split, Cut or Torn	18	18
Insufficient Information	17	18
Poor Visibility	15	15
Device Damaged Prior to Use	14	14
Material Integrity Problem	14	14
Leak/Splash	14	14
Device Markings/Labelling Problem	13	13
Material Twisted/Bent	13	14
Patient-Device Incompatibility	12	13
Structural Problem	11	11
Migration or Expulsion of Device	10	10
Premature Separation	9	9
Defective Component	9	9
Burst Container or Vessel	9	9
Material Frayed	7	7
Unsealed Device Packaging	7	7
Inflation Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1840	1857
Obstruction/Occlusion	123	124
Foreign Body In Patient	82	83
Thrombosis/Thrombus	75	77
Restenosis	66	67
Insufficient Information	66	66
Stenosis	61	61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Device Embedded In Tissue or Plaque	56	59
Vascular Dissection	50	51
Pain	41	41
Ischemia	34	34
Embolism/Embolus	29	29
Hemorrhage/Bleeding	28	28
Hematoma	28	28
Unspecified Tissue Injury	26	26
Renal Failure	18	18
Unspecified Infection	15	15
Perforation of Vessels	13	13
Death	12	12
No Consequences Or Impact To Patient	11	11
Stroke/CVA	10	10
Aneurysm	10	10
Pseudoaneurysm	9	9
Occlusion	9	9
Rupture	9	9
Myocardial Infarction	7	7
No Known Impact Or Consequence To Patient	7	7
Fistula	6	6
Respiratory Failure	6	6
Hypersensitivity/Allergic reaction	6	6
Renal Impairment	6	6
Blood Loss	6	6
Valvular Stenosis	5	5
Dyspnea	5	5
High Blood Pressure/ Hypertension	5	5
Perforation	5	5
Cardiac Arrest	4	4
Failure of Implant	4	4
Swelling/ Edema	4	4
Numbness	4	4
Pulmonary Embolism	3	3
Thrombus	3	3
Low Blood Pressure/ Hypotension	3	3
Unspecified Vascular Problem	3	3
Thromboembolism	3	3
Unspecified Heart Problem	3	3
Hypoxia	3	3
Embolism	3	3
Calcium Deposits/Calcification	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Cordis US Corp	II	Apr-03-2025