TPLC - Total Product Life Cycle

show TPLC since

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	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	325	325
Activation, Positioning or Separation Problem	126	126
Difficult or Delayed Positioning	98	98
Material Deformation	85	85
Break	59	59
Difficult to Advance	57	57
Premature Activation	56	56
Difficult to Remove	56	56
Positioning Failure	50	50
Activation Failure	48	48
Material Separation	37	37
Detachment of Device or Device Component	36	36
Mechanical Problem	25	25
Fracture	25	25
Entrapment of Device	24	24
Failure to Advance	20	20
Positioning Problem	19	19
Malposition of Device	18	18
Mechanical Jam	17	17
Device Markings/Labelling Problem	16	16
Defective Device	14	14
Physical Resistance/Sticking	12	12
Material Integrity Problem	11	11
Migration	10	10
Device Dislodged or Dislocated	9	9
Patient-Device Incompatibility	9	9
Difficult to Insert	9	9
Deformation Due to Compressive Stress	7	7
Peeled/Delaminated	7	7
Difficult or Delayed Activation	7	7
Device-Device Incompatibility	6	6
Material Split, Cut or Torn	6	6
Migration or Expulsion of Device	6	6
Improper or Incorrect Procedure or Method	6	6
Device Contamination with Chemical or Other Material	6	6
Use of Device Problem	6	6
Crack	5	5
Loss of or Failure to Bond	4	4
Unsealed Device Packaging	4	4
Material Frayed	4	4
Obstruction of Flow	3	3
Component Missing	3	3
Appropriate Term/Code Not Available	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
Tear, Rip or Hole in Device Packaging	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	548	548
Thrombosis/Thrombus	146	146
Stroke/CVA	100	100
No Consequences Or Impact To Patient	93	93
Ischemia Stroke	87	87
Obstruction/Occlusion	44	44
Stenosis	37	37
Transient Ischemic Attack	34	34
Myocardial Infarction	27	27
Restenosis	25	25
Vascular Dissection	25	25
Muscle Weakness	23	23
Low Blood Pressure/ Hypotension	19	19
Insufficient Information	19	19
Dysphasia	14	14
Bradycardia	14	14
Brain Injury	14	14
Foreign Body In Patient	12	12
Intracranial Hemorrhage	12	12
Hematoma	12	12
Embolism/Embolus	11	11
Unspecified Tissue Injury	11	11
Hemorrhage/Bleeding	9	9
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
Convulsion/Seizure	5	5
Perforation of Vessels	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
High Blood Pressure/ Hypertension	4	4
Aneurysm	3	3
Headache	3	3
Visual Impairment	3	3
Loss of consciousness	3	3
Thrombus	3	3
Unspecified Infection	3	3
Unspecified Nervous System Problem	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Death	3	3
Confusion/ Disorientation	3	3
Seizures	3	3