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	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	475	475
Adverse Event Without Identified Device or Use Problem	394	394
Activation Failure	304	310
Difficult to Remove	243	245
Material Deformation	207	208
Off-Label Use	199	201
Premature Activation	186	191
Difficult to Advance	183	185
Failure to Advance	174	175
Improper or Incorrect Procedure or Method	170	172
Mechanical Jam	159	163
Detachment of Device or Device Component	130	130
Break	115	116
Positioning Failure	100	100
Misfire	91	91
Positioning Problem	91	91
Material Separation	85	92
Difficult or Delayed Activation	80	80
Fracture	71	72
Difficult or Delayed Positioning	66	66
Physical Resistance/Sticking	65	65
Migration	64	64
Activation, Positioning or Separation Problem	56	56
Entrapment of Device	50	50
Stretched	46	46
Material Rupture	37	39
Malposition of Device	36	36
Device-Device Incompatibility	32	33
Deformation Due to Compressive Stress	27	27
Defective Device	24	24
Leak/Splash	23	23
Difficult to Insert	23	24
Use of Device Problem	22	22
Patient-Device Incompatibility	21	22
Material Split, Cut or Torn	21	21
Insufficient Information	21	21
Migration or Expulsion of Device	20	20
Device Damaged by Another Device	17	17
Device Damaged Prior to Use	15	15
Poor Visibility	15	15
Material Integrity Problem	15	15
Material Twisted/Bent	14	15
Device Markings/Labelling Problem	13	13
Burst Container or Vessel	13	13
Structural Problem	13	13
Obstruction of Flow	11	11
Material Frayed	11	11
Complete Blockage	10	10
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	1655	1667
No Consequences Or Impact To Patient	161	161
Obstruction/Occlusion	126	126
Foreign Body In Patient	80	81
Thrombosis/Thrombus	73	75
Insufficient Information	71	71
Restenosis	68	69
Stenosis	67	67
Device Embedded In Tissue or Plaque	57	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Vascular Dissection	54	55
No Known Impact Or Consequence To Patient	49	49
Ischemia	41	41
Pain	39	39
No Information	38	38
Occlusion	36	36
Death	33	33
Hematoma	32	32
Hemorrhage/Bleeding	28	28
Embolism/Embolus	26	26
Blood Loss	25	25
No Code Available	24	24
Unspecified Tissue Injury	22	22
No Patient Involvement	19	19
Unspecified Infection	19	19
Renal Failure	18	18
Aneurysm	16	16
Pseudoaneurysm	15	15
Thrombosis	14	14
Stroke/CVA	13	13
Perforation of Vessels	12	12
Myocardial Infarction	10	10
Rupture	10	10
Injury	10	10
Perforation	8	8
Thromboembolism	7	7
Hypersensitivity/Allergic reaction	7	7
High Blood Pressure/ Hypertension	7	7
Embolism	6	6
Reocclusion	6	6
Renal Impairment	6	6
Dyspnea	6	6
Respiratory Failure	6	6
Fistula	6	6
Valvular Stenosis	5	5
Cardiac Arrest	4	4
Seroma	4	4
Vessel Or Plaque, Device Embedded In	4	4
Low Blood Pressure/ Hypotension	4	4
Failure of Implant	4	4

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