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)
2021	2022	2023	2024	2025	2026
13	17	14	21	24	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	487	487
Difficult to Remove	181	181
Activation, Positioning or Separation Problem	160	160
Difficult or Delayed Positioning	126	126
Activation Failure	110	110
Entrapment of Device	108	108
Material Deformation	98	98
Difficult to Advance	78	78
Break	72	72
Premature Activation	67	67
Positioning Failure	47	47
Insufficient Device Problem Information	43	43
Mechanical Problem	41	41
Positioning Problem	40	40
Detachment of Device or Device Component	39	39
Material Separation	37	37
Defective Device	28	28
Mechanical Jam	27	27
Fracture	24	24
Failure to Advance	23	23
Malposition of Device	22	22
Migration	21	21
Device Markings/Labelling Problem	18	18
Device-Device Incompatibility	16	16
Difficult or Delayed Activation	16	16
Patient-Device Incompatibility	15	15
Difficult to Insert	14	14
Material Integrity Problem	13	13
Physical Resistance/Sticking	13	13
Deformation Due to Compressive Stress	13	13
Peeled/Delaminated	11	11
Difficult to Open or Close	11	11
Device Dislodged or Dislocated	8	8
Loss of or Failure to Bond	8	8
Unsealed Device Packaging	7	7
Improper or Incorrect Procedure or Method	7	7
Material Split, Cut or Torn	7	8
Use of Device Problem	7	7
Nonstandard Device	6	6
Device Contamination with Chemical or Other Material	6	6
Migration or Expulsion of Device	5	5
Appropriate Device Problem Term/Code Not Available	4	4
Component Missing	4	4
Crack	4	4
Material Frayed	4	5
Obstruction of Flow	3	3
Tear, Rip or Hole in Device Packaging	3	3
Contamination	3	3
Defective Component	3	3
Off-Label Use	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1044	1045
Thrombosis/Thrombus	179	179
Stroke/CVA	142	142
Ischemia Stroke	117	117
Obstruction/Occlusion	67	67
Restenosis	48	48
Transient Ischemic Attack	45	45
Myocardial Infarction	39	39
Stenosis	39	39
Muscle Weakness/Atrophy	37	37
Low Blood Pressure/ Hypotension	34	34
Vascular Dissection	32	32
Insufficient Information	30	30
Dysphasia	23	23
Intracranial Hemorrhage	18	18
Hematoma	17	17
Embolism/Embolus	17	17
Hemorrhagic Stroke	16	16
High Blood Pressure/ Hypertension	16	16
Hemorrhage/Blood Loss/Bleeding	13	13
Bradycardia	13	13
Unspecified Tissue Injury	11	11
Paralysis	10	10
Paresis	10	10
Foreign Body In Patient	10	10
Headache	9	9
Speech Disorder	8	8
Convulsion/Seizure	7	7
Perforation of Vessels	7	7
Pain	7	7
Vasoconstriction	6	6
Brain Injury	6	6
Ischemia	6	6
Arrhythmia	5	5
Dizziness	5	5
Swelling/ Edema	5	5
Facial Paralysis	5	5
Cerebral Hyperperfusion Syndrome	4	4
Nervous System Injury	4	4
Confusion/ Disorientation	4	4
Inflammation	4	4
Hypersensitivity/Allergic reaction	4	4
Aneurysm	4	4
Cardiac Arrest	3	3
Perforation	3	3
Visual Impairment	3	3
Loss of Vision	3	3
Pseudoaneurysm	3	3
Loss of consciousness	3	3
Cerebral Edema	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Aug-08-2025
2	Contego Medical LLC	II	Oct-10-2025
3	Cordis Corporation	I	Mar-15-2021
4	INSPIREMD Inc	II	Jun-05-2026
5	Silk Road Medical Inc	II	Feb-23-2021