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)
2019	2020	2021	2022	2023	2024
20	22	9	5	7	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	781	781
Activation, Positioning or Separation Problem	239	239
Material Deformation	212	212
Fracture	130	130
Entrapment of Device	77	77
Activation Failure	66	66
Improper or Incorrect Procedure or Method	53	53
Premature Activation	50	50
Off-Label Use	49	49
Difficult to Remove	38	38
Obstruction of Flow	33	33
Failure to Advance	27	27
Difficult or Delayed Positioning	26	26
Structural Problem	24	24
Positioning Problem	24	24
Appropriate Term/Code Not Available	22	22
Difficult to Advance	22	22
Break	19	19
Material Integrity Problem	18	18
Deformation Due to Compressive Stress	15	15
Difficult or Delayed Activation	15	15
Use of Device Problem	14	14
Positioning Failure	13	13
Defective Device	12	12
Detachment of Device or Device Component	10	10
Physical Resistance/Sticking	10	10
Migration	9	9
Insufficient Information	8	8
Difficult to Insert	6	6
Device-Device Incompatibility	6	6
Stretched	5	5
Patient Device Interaction Problem	5	5
Device Markings/Labelling Problem	5	5
Expiration Date Error	4	4
Poor Visibility	4	4
Retraction Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Dent in Material	3	3
Biocompatibility	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Contamination	2	2
Material Twisted/Bent	2	2
Unsealed Device Packaging	2	2
Partial Blockage	2	2
Material Separation	2	2
Collapse	2	2
Activation Problem	2	2
Compatibility Problem	2	2
Material Fragmentation	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	433	433
Restenosis	243	243
No Consequences Or Impact To Patient	164	164
Obstruction/Occlusion	161	161
Thrombosis/Thrombus	127	127
Reocclusion	121	121
Pain	108	108
Thrombosis	100	100
Occlusion	81	81
No Known Impact Or Consequence To Patient	73	73
Arteriosclerosis/ Atherosclerosis	53	53
Ischemia	46	46
Stenosis	42	42
No Code Available	35	35
Claudication	32	32
Vascular Dissection	28	28
Insufficient Information	24	24
Aneurysm	23	23
Pseudoaneurysm	22	22
Foreign Body In Patient	19	19
No Information	19	19
Numbness	15	15
Ulcer	14	14
Swelling/ Edema	13	13
Embolism/Embolus	12	12
Hemorrhage/Bleeding	10	10
Hypersensitivity/Allergic reaction	8	8
Ruptured Aneurysm	7	7
Necrosis	6	6
Discomfort	6	6
Device Embedded In Tissue or Plaque	6	6
Hematoma	5	5
Inflammation	5	5
Embolism	5	5
Injury	5	5
Unspecified Vascular Problem	5	5
Vasoconstriction	4	4
Muscle Weakness	4	4
Disability	4	4
Failure of Implant	4	4
Death	4	4
Hypovolemia	4	4
Unspecified Infection	4	4
Unspecified Tissue Injury	3	3
Dyspnea	3	3
Movement Disorder	3	3
Paresthesia	3	3
Reaction to Medicinal Component of Device	3	3
Skin Inflammation/ Irritation	3	3
Post Operative Wound Infection	2	2

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