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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	1	8	0	6	5	4	10	20	22	9	5	7	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	851	851
Occlusion Within Device	465	465
Activation, Positioning or Separation Problem	407	407
Fracture	272	272
Material Deformation	215	215
Entrapment of Device	90	90
Activation Failure	66	66
Difficult to Remove	62	62
Premature Activation	56	56
Obstruction of Flow	52	52
Improper or Incorrect Procedure or Method	52	52
Device Operates Differently Than Expected	46	46
Insufficient Information	45	45
Off-Label Use	45	45
Stretched	43	43
Difficult or Delayed Positioning	34	34
Break	34	34
Appropriate Term/Code Not Available	31	31
Delivery System Failure	30	30
Positioning Problem	27	27
Failure to Advance	26	26
Difficult to Advance	24	24
Structural Problem	23	23
Bent	19	19
Material Integrity Problem	19	19
Positioning Failure	18	18
Use of Device Problem	16	16
Deformation Due to Compressive Stress	16	16
Difficult or Delayed Activation	15	15
Defective Device	13	13
Detachment of Device or Device Component	10	10
Migration	10	10
Physical Resistance/Sticking	10	10
Device Expiration Issue	8	8
Partial Blockage	6	6
Device-Device Incompatibility	6	6
Difficult to Insert	6	6
No Apparent Adverse Event	5	5
Device Contamination with Chemical or Other Material	5	5
Device Markings/Labelling Problem	5	5
Expiration Date Error	5	5
Kinked	5	5
Packaging Problem	5	5
Patient Device Interaction Problem	5	5
Difficult to Open or Remove Packaging Material	5	5
Retraction Problem	4	4
Poor Visibility	4	4
Therapeutic or Diagnostic Output Failure	4	4
Migration or Expulsion of Device	4	4
Malposition of Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Reocclusion	494	495
No Clinical Signs, Symptoms or Conditions	415	415
No Consequences Or Impact To Patient	345	345
Restenosis	237	237
Occlusion	224	224
No Known Impact Or Consequence To Patient	201	201
Thrombosis	177	177
Claudication	172	173
Surgical procedure, additional	166	166
Obstruction/Occlusion	151	151
Pain	139	139
Thrombosis/Thrombus	126	126
Stenosis	81	82
No Code Available	62	62
Arteriosclerosis/ Atherosclerosis	52	52
Ischemia	50	50
Vascular Dissection	30	30
Aneurysm	28	28
Pseudoaneurysm	28	28
Foreign Body In Patient	27	27
Device Embedded In Tissue or Plaque	27	27
No Information	24	24
Insufficient Information	24	24
Ulcer	16	16
Numbness	16	16
Ulceration	14	14
Swelling/ Edema	13	13
Hemorrhage/Bleeding	12	12
Amputation	11	11
Embolism/Embolus	11	11
Hypersensitivity/Allergic reaction	8	8
Thrombus	8	8
Unspecified Infection	8	8
Ruptured Aneurysm	7	7
Death	7	7
Discomfort	7	7
Embolism	6	6
Inflammation	6	6
Injury	6	6
Necrosis	5	5
Hematoma	5	5
Vasoconstriction	5	5
Unspecified Vascular Problem	5	5
Rash	5	5
Perforation of Vessels	4	4
Hypovolemia	4	4
Failure of Implant	4	4
Therapy/non-surgical treatment, additional	4	4
Disability	4	4
Aspiration/Inhalation	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	May-18-2021
2	Cook, Inc.	I	May-15-2013