TPLC - Total Product Life Cycle

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Device	stent, iliac vein
Definition	A metal scaffold placed via a delivery catheter in the iliac vein to maintain the lumen
Product Code	QAN
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
10	11	5	7	9	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	420	420
Adverse Event Without Identified Device or Use Problem	163	163
Material Deformation	95	95
Migration	89	89
Fracture	67	67
Activation, Positioning or Separation Problem	66	66
Improper or Incorrect Procedure or Method	51	51
Migration or Expulsion of Device	39	39
Off-Label Use	38	38
Positioning Failure	36	36
Malposition of Device	29	29
Entrapment of Device	27	27
Use of Device Problem	27	27
Difficult to Remove	26	26
Misfire	25	25
Break	22	22
Detachment of Device or Device Component	21	21
Difficult or Delayed Positioning	20	20
Deformation Due to Compressive Stress	18	18
Premature Activation	17	17
Obstruction of Flow	15	15
Difficult to Advance	11	11
Material Twisted/Bent	11	11
Device Damaged by Another Device	9	9
Physical Resistance/Sticking	8	8
Device Markings/Labelling Problem	8	8
Positioning Problem	8	8
No Apparent Adverse Event	8	8
Device-Device Incompatibility	7	7
Loss of or Failure to Bond	7	7
Structural Problem	6	6
Mechanical Problem	4	4
Activation Problem	4	4
Appropriate Term/Code Not Available	4	4
Device Dislodged or Dislocated	4	4
Material Fragmentation	4	4
Nonstandard Device	3	3
Failure to Advance	3	3
Packaging Problem	3	3
Delivered as Unsterile Product	3	3
Difficult or Delayed Activation	3	3
Defective Device	3	3
Device Damaged Prior to Use	3	3
Material Too Rigid or Stiff	2	2
Material Separation	2	2
Stretched	2	2
Inaccurate Information	2	2
Biocompatibility	2	2
Sharp Edges	1	1
Material Rupture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	726	726
Thrombosis/Thrombus	85	85
Insufficient Information	59	59
Obstruction/Occlusion	56	56
Pain	38	38
Restenosis	26	26
Stenosis	17	17
No Consequences Or Impact To Patient	16	16
Swelling/ Edema	16	16
Chest Pain	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Dyspnea	12	12
Device Embedded In Tissue or Plaque	9	9
Unspecified Tissue Injury	7	7
Pulmonary Embolism	6	6
Hypersensitivity/Allergic reaction	6	6
Foreign Body In Patient	6	6
Perforation	6	6
Hemorrhage/Bleeding	5	5
No Code Available	5	5
Failure of Implant	5	5
Unintended Radiation Exposure	4	4
Unspecified Heart Problem	4	4
Swelling	4	4
Injury	4	4
Pericardial Effusion	4	4
Stroke/CVA	4	4
Arrhythmia	3	3
Ulcer	3	3
Tachycardia	3	3
No Known Impact Or Consequence To Patient	3	3
Cellulitis	3	3
Stacking Breaths	3	3
Embolism/Embolus	3	3
Thrombosis	3	3
Respiratory Insufficiency	2	2
Unspecified Infection	2	2
Pseudoaneurysm	2	2
Perforation of Vessels	2	2
Pancreatitis	2	2
Nausea	2	2
Foreign Body Embolism	2	2
Nerve Damage	2	2
Fever	2	2
Rash	2	2
Paralysis	2	2
Local Reaction	2	2
Rupture	2	2
Atrial Fibrillation	2	2
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Jun-17-2021
2	Boston Scientific Corporation	I	May-19-2021
3	Medtronic Inc.	II	Mar-19-2024
4	Medtronic Inc.	II	May-05-2021
5	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jan-06-2022