TPLC - Total Product Life Cycle

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Device	stent, carotid
Definition	Stent, Carotid -- a metal scaffold placed via a delivery catheter into the carotid artery to maintain the lumen
Product Code	NIM
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
7	13	17	14	21	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	352	352
Activation, Positioning or Separation Problem	149	149
Difficult or Delayed Positioning	109	109
Material Deformation	97	97
Difficult to Remove	70	70
Break	69	69
Activation Failure	62	62
Difficult to Advance	61	61
Premature Activation	59	59
Positioning Failure	52	52
Detachment of Device or Device Component	41	41
Entrapment of Device	40	40
Material Separation	38	38
Mechanical Problem	30	30
Fracture	28	28
Failure to Advance	22	22
Positioning Problem	22	22
Defective Device	20	20
Malposition of Device	18	18
Mechanical Jam	18	18
Device Markings/Labelling Problem	16	16
Migration	12	12
Physical Resistance/Sticking	12	12
Material Integrity Problem	12	12
Peeled/Delaminated	10	10
Device Dislodged or Dislocated	10	10
Patient-Device Incompatibility	10	10
Device-Device Incompatibility	9	9
Deformation Due to Compressive Stress	9	9
Difficult to Insert	9	9
Material Split, Cut or Torn	7	7
Difficult or Delayed Activation	7	7
Migration or Expulsion of Device	6	6
Device Contamination with Chemical or Other Material	6	6
Use of Device Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Loss of or Failure to Bond	5	5
Crack	5	5
Unsealed Device Packaging	4	4
Appropriate Term/Code Not Available	4	4
Material Frayed	4	4
Component Missing	3	3
Obstruction of Flow	3	3
Difficult to Open or Remove Packaging Material	3	3
Off-Label Use	3	3
Device Difficult to Setup or Prepare	2	2
Contamination	2	2
Therapeutic or Diagnostic Output Failure	2	2
Loose or Intermittent Connection	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	642	642
Thrombosis/Thrombus	152	152
Stroke/CVA	103	103
Ischemia Stroke	94	94
No Consequences Or Impact To Patient	93	93
Obstruction/Occlusion	52	52
Stenosis	40	40
Transient Ischemic Attack	35	35
Restenosis	30	30
Myocardial Infarction	29	29
Vascular Dissection	27	27
Muscle Weakness	24	24
Low Blood Pressure/ Hypotension	22	22
Insufficient Information	19	19
Dysphasia	15	15
Bradycardia	14	14
Brain Injury	14	14
Intracranial Hemorrhage	13	13
Hematoma	13	13
Foreign Body In Patient	12	12
Embolism/Embolus	11	11
Unspecified Tissue Injury	11	11
Hemorrhage/Bleeding	11	11
Perforation of Vessels	7	7
No Patient Involvement	7	7
No Known Impact Or Consequence To Patient	7	7
Dizziness	6	6
Thrombosis	6	6
Patient Problem/Medical Problem	6	6
High Blood Pressure/ Hypertension	6	6
Convulsion/Seizure	5	5
Speech Disorder	5	5
Paresis	5	5
Pain	5	5
Occlusion	4	4
Vasoconstriction	4	4
Swelling/ Edema	4	4
Extravasation	4	4
Nervous System Injury	4	4
Aneurysm	3	3
Headache	3	3
Visual Impairment	3	3
Loss of consciousness	3	3
Thrombus	3	3
Unspecified Nervous System Problem	3	3
Confusion/ Disorientation	3	3
Unspecified Infection	3	3
Cardiac Arrest	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hemorrhagic Stroke	3	3