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	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	452	452
Difficult to Remove	174	174
Activation, Positioning or Separation Problem	151	151
Difficult or Delayed Positioning	117	117
Entrapment of Device	105	105
Activation Failure	99	99
Material Deformation	98	98
Difficult to Advance	71	71
Break	68	68
Premature Activation	64	64
Positioning Failure	47	47
Insufficient Information	43	43
Mechanical Problem	39	39
Material Separation	37	37
Detachment of Device or Device Component	37	37
Positioning Problem	36	36
Defective Device	28	28
Fracture	24	24
Mechanical Jam	24	24
Failure to Advance	23	23
Migration	21	21
Malposition of Device	19	19
Device Markings/Labelling Problem	17	17
Device-Device Incompatibility	15	15
Material Integrity Problem	13	13
Difficult to Insert	13	13
Patient-Device Incompatibility	12	12
Physical Resistance/Sticking	12	12
Peeled/Delaminated	11	11
Difficult to Open or Close	11	11
Difficult or Delayed Activation	11	11
Deformation Due to Compressive Stress	10	10
Device Dislodged or Dislocated	8	8
Unsealed Device Packaging	7	7
Improper or Incorrect Procedure or Method	7	7
Material Split, Cut or Torn	7	8
Device Contamination with Chemical or Other Material	6	6
Loss of or Failure to Bond	6	6
Nonstandard Device	5	5
Migration or Expulsion of Device	5	5
Use of Device Problem	5	5
Appropriate Term/Code Not Available	4	4
Crack	4	4
Material Frayed	4	5
Obstruction of Flow	3	3
Component Missing	3	3
Tear, Rip or Hole in Device Packaging	3	3
Contamination	3	3
Defective Component	3	3
Device Damaged by Another Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	981	982
Thrombosis/Thrombus	171	171
Stroke/CVA	135	135
Ischemia Stroke	114	114
Obstruction/Occlusion	63	63
Restenosis	43	43
Transient Ischemic Attack	42	42
Myocardial Infarction	39	39
Stenosis	39	39
Muscle Weakness	36	36
Vascular Dissection	31	31
Insufficient Information	30	30
Low Blood Pressure/ Hypotension	28	28
Dysphasia	20	20
Intracranial Hemorrhage	18	18
Hematoma	17	17
Embolism/Embolus	17	17
Hemorrhage/Bleeding	13	13
High Blood Pressure/ Hypertension	13	13
Bradycardia	13	13
Hemorrhagic Stroke	12	12
Unspecified Tissue Injury	11	11
Foreign Body In Patient	10	10
Paresis	8	8
Speech Disorder	7	7
Perforation of Vessels	7	7
Paralysis	7	7
Headache	6	6
Convulsion/Seizure	6	6
Brain Injury	6	6
Pain	6	6
Ischemia	6	6
Vasoconstriction	6	6
Dizziness	5	5
Arrhythmia	5	5
Confusion/ Disorientation	4	4
Nervous System Injury	4	4
Swelling/ Edema	4	4
Aneurysm	4	4
Unspecified Nervous System Problem	3	3
Cardiac Arrest	3	3
Cerebral Hyperperfusion Syndrome	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Loss of consciousness	3	3
Visual Impairment	3	3
Loss of Vision	3	3
Pseudoaneurysm	3	3
Hypersensitivity/Allergic reaction	3	3
Neurological Deficit/Dysfunction	2	2
Device Embedded In Tissue or Plaque	2	2

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	Silk Road Medical Inc	II	Feb-23-2021