TPLC - Total Product Life Cycle

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Device	stent, superficial femoral artery, drug-eluting
Definition	Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.
Product Code	NIU
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
22	9	5	7	7	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	659	659
Activation, Positioning or Separation Problem	212	212
Material Deformation	193	193
Fracture	111	111
Entrapment of Device	69	69
Activation Failure	65	65
Improper or Incorrect Procedure or Method	53	53
Off-Label Use	51	51
Premature Activation	45	45
Difficult to Remove	32	32
Failure to Advance	25	25
Structural Problem	24	24
Difficult or Delayed Positioning	23	23
Difficult to Advance	22	22
Positioning Problem	21	21
Break	15	15
Material Integrity Problem	15	15
Defective Device	13	13
Positioning Failure	13	13
Obstruction of Flow	13	13
Deformation Due to Compressive Stress	12	12
Difficult or Delayed Activation	12	12
Use of Device Problem	10	10
Physical Resistance/Sticking	8	8
Migration	8	8
Detachment of Device or Device Component	8	8
Device-Device Incompatibility	6	6
Device Markings/Labelling Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Difficult to Insert	5	5
Insufficient Information	4	4
Patient Device Interaction Problem	4	4
Poor Visibility	4	4
Biocompatibility	3	3
Dent in Material	3	3
Contamination	3	3
Expiration Date Error	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Partial Blockage	2	2
Retraction Problem	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Unsealed Device Packaging	2	2
Collapse	2	2
Appropriate Term/Code Not Available	2	2
Activation Problem	2	2
Compatibility Problem	2	2
Material Twisted/Bent	1	1
Stretched	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	458	458
Restenosis	256	256
Obstruction/Occlusion	167	167
Thrombosis/Thrombus	139	139
No Consequences Or Impact To Patient	95	95
Pain	93	93
Thrombosis	63	63
Arteriosclerosis/ Atherosclerosis	57	57
Reocclusion	57	57
Ischemia	40	40
No Known Impact Or Consequence To Patient	40	40
Stenosis	35	35
Occlusion	30	30
Vascular Dissection	26	26
Insufficient Information	25	25
Pseudoaneurysm	22	22
Claudication	21	21
Foreign Body In Patient	21	21
Aneurysm	19	19
No Code Available	18	18
Ulcer	14	14
Numbness	14	14
Swelling/ Edema	13	13
Embolism/Embolus	13	13
No Information	10	10
Hypersensitivity/Allergic reaction	9	9
Hemorrhage/Bleeding	9	9
Ruptured Aneurysm	7	7
Necrosis	6	6
Discomfort	6	6
Unspecified Vascular Problem	5	5
Hematoma	5	5
Muscle Weakness	5	5
Device Embedded In Tissue or Plaque	4	4
Unspecified Tissue Injury	4	4
Vasoconstriction	4	4
Unspecified Infection	4	4
Injury	3	3
Dyspnea	3	3
Paresthesia	3	3
Movement Disorder	3	3
Reaction to Medicinal Component of Device	3	3
Inflammation	3	3
Embolism	3	3
Skin Inflammation/ Irritation	3	3
Thromboembolism	3	3
Post Operative Wound Infection	2	2
Perforation of Vessels	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Perforation	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	May-18-2021