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)
2019	2020	2021	2022	2023	2024
11	7	13	17	14	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	333	333
Activation, Positioning or Separation Problem	117	117
Difficult or Delayed Positioning	108	108
Material Deformation	90	90
Difficult to Remove	60	60
Premature Activation	57	57
Activation Failure	57	57
Break	55	55
Difficult to Advance	55	55
Detachment of Device or Device Component	48	48
Positioning Failure	46	46
Material Separation	45	45
Entrapment of Device	25	25
Mechanical Problem	24	24
Fracture	24	24
Failure to Advance	23	23
Malposition of Device	21	21
Mechanical Jam	20	20
Positioning Problem	17	17
Defective Device	13	13
Migration	12	12
Physical Resistance/Sticking	12	12
Material Integrity Problem	11	11
Deformation Due to Compressive Stress	10	10
Device Dislodged or Dislocated	9	9
Material Split, Cut or Torn	9	9
Patient-Device Incompatibility	8	8
Device Contamination with Chemical or Other Material	7	7
Difficult or Delayed Activation	7	7
Device-Device Incompatibility	7	7
Migration or Expulsion of Device	7	7
Peeled/Delaminated	7	7
Improper or Incorrect Procedure or Method	6	6
Difficult to Insert	6	6
Crack	6	6
Material Frayed	5	5
Loss of or Failure to Bond	4	4
Leak/Splash	4	4
Off-Label Use	4	4
Use of Device Problem	4	4
Unsealed Device Packaging	3	3
Appropriate Term/Code Not Available	3	3
Difficult to Open or Remove Packaging Material	3	3
Tear, Rip or Hole in Device Packaging	3	3
Loose or Intermittent Connection	2	2
Activation Problem	2	2
Device Markings/Labelling Problem	2	2
Difficult to Flush	2	2
Device Damaged by Another Device	2	2
Obstruction of Flow	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	450	450
No Consequences Or Impact To Patient	180	180
Thrombosis/Thrombus	124	124
Stroke/CVA	97	97
Ischemia Stroke	76	76
Transient Ischemic Attack	41	41
Stenosis	37	37
Patient Problem/Medical Problem	36	36
Vascular Dissection	31	31
Obstruction/Occlusion	30	30
Myocardial Infarction	28	28
Restenosis	24	24
Low Blood Pressure/ Hypotension	24	24
Thrombosis	21	21
No Patient Involvement	19	19
Insufficient Information	17	17
Hematoma	17	17
Brain Injury	16	16
Foreign Body In Patient	16	16
Bradycardia	15	15
Occlusion	14	14
Pain	13	13
No Known Impact Or Consequence To Patient	13	13
Muscle Weakness	11	11
Intracranial Hemorrhage	11	11
Thrombus	10	10
Dysphasia	9	9
Unspecified Tissue Injury	9	9
Embolism/Embolus	9	9
Death	8	8
Embolism	8	8
Blood Loss	8	8
Arrhythmia	7	7
Renal Failure	7	7
High Blood Pressure/ Hypertension	6	6
Hemorrhage/Bleeding	6	6
Device Embedded In Tissue or Plaque	5	5
Convulsion/Seizure	5	5
Dizziness	5	5
Vasoconstriction	5	5
Nervous System Injury	4	4
Speech Disorder	4	4
Neurological Deficit/Dysfunction	4	4
Swelling/ Edema	4	4
Extravasation	4	4
Perforation of Vessels	4	4
Reocclusion	4	4
Ischemia	4	4
Paresis	4	4
Unspecified Infection	3	3