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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	411	411
Adverse Event Without Identified Device or Use Problem	322	322
Difficult to Remove	206	206
Activation Failure	188	188
Off-Label Use	181	181
Material Deformation	174	174
Difficult to Advance	153	153
Failure to Advance	146	146
Premature Activation	138	138
Improper or Incorrect Procedure or Method	121	121
Detachment of Device or Device Component	108	108
Break	92	92
Positioning Problem	86	86
Positioning Failure	86	86
Misfire	83	83
Mechanical Jam	74	74
Fracture	68	68
Migration	60	60
Difficult or Delayed Positioning	56	56
Activation, Positioning or Separation Problem	55	55
Material Separation	52	52
Difficult or Delayed Activation	42	42
Entrapment of Device	40	40
Physical Resistance/Sticking	36	36
Malposition of Device	33	33
Device-Device Incompatibility	30	30
Stretched	30	30
Material Rupture	29	30
Deformation Due to Compressive Stress	22	22
Defective Device	22	22
Leak/Splash	22	22
Difficult to Insert	22	22
Insufficient Information	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	17	17
Device Damaged Prior to Use	14	14
Device Damaged by Another Device	14	14
Poor Visibility	14	14
Material Integrity Problem	13	13
Material Twisted/Bent	12	12
Burst Container or Vessel	12	12
Obstruction of Flow	11	11
Complete Blockage	10	10
Material Frayed	10	10
Structural Problem	9	9
Device Markings/Labelling Problem	9	9
Premature Separation	9	9
Inflation Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1325	1328
No Consequences Or Impact To Patient	161	161
Obstruction/Occlusion	91	91
Insufficient Information	69	69
Foreign Body In Patient	65	65
Restenosis	58	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
Thrombosis/Thrombus	52	52
Stenosis	51	51
No Known Impact Or Consequence To Patient	49	49
Vascular Dissection	47	47
Device Embedded In Tissue or Plaque	45	45
No Information	38	38
Occlusion	36	36
Ischemia	35	35
Death	33	33
Hematoma	31	31
Hemorrhage/Bleeding	25	25
Pain	25	25
Blood Loss	25	25
No Code Available	24	24
Embolism/Embolus	21	21
Unspecified Tissue Injury	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
High Blood Pressure/ Hypertension	6	6
Embolism	6	6
Fistula	5	5
Renal Impairment	5	5
Valvular Stenosis	5	5
Failure of Implant	4	4
Dyspnea	4	4
Seroma	4	4
Low Blood Pressure/ Hypotension	4	4
Respiratory Failure	4	4
Vessel Or Plaque, Device Embedded In	4	4
Thrombus	3	3

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