TPLC - Total Product Life Cycle

• 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)
2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	4	10	11	5	7	3

MDR Year	MDR Reports	MDR Events
2019	24	24
2020	117	117
2021	425	425
2022	115	115
2023	208	208
2024	21	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	403	403
Adverse Event Without Identified Device or Use Problem	118	118
Migration	80	80
Material Deformation	77	77
Activation, Positioning or Separation Problem	58	58
Fracture	56	56
Improper or Incorrect Procedure or Method	42	42
Migration or Expulsion of Device	32	32
Off-Label Use	31	31
Positioning Failure	30	30
Entrapment of Device	30	30
Difficult to Remove	25	25
Use of Device Problem	24	24
Misfire	23	23
Difficult or Delayed Positioning	20	20
Break	20	20
Malposition of Device	19	19
Deformation Due to Compressive Stress	18	18
Detachment of Device or Device Component	16	16
Premature Activation	11	11
Obstruction of Flow	11	11
Material Twisted/Bent	10	10
No Apparent Adverse Event	8	8
Positioning Problem	8	8
Device Damaged by Another Device	7	7
Physical Resistance/Sticking	7	7
Device-Device Incompatibility	6	6
Device Markings/Labelling Problem	6	6
Difficult to Advance	5	5
Loss of or Failure to Bond	5	5
Structural Problem	5	5
Activation Problem	4	4
Appropriate Term/Code Not Available	4	4
Mechanical Problem	4	4
Material Fragmentation	4	4
Nonstandard Device	3	3
Defective Device	3	3
Device Damaged Prior to Use	3	3
Failure to Advance	3	3
Material Integrity Problem	3	3
Human-Device Interface Problem	2	2
Retraction Problem	2	2
Device Dislodged or Dislocated	2	2
Delivered as Unsterile Product	2	2
Difficult or Delayed Activation	2	2
Stretched	2	2
Material Too Rigid or Stiff	2	2
Material Separation	2	2
Inaccurate Information	2	2
Mechanical Jam	1	1
Material Protrusion/Extrusion	1	1
Poor Quality Image	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Open or Remove Packaging Material	1	1
Insufficient Information	1	1
Labelling, Instructions for Use or Training Problem	1	1
Biocompatibility	1	1
Fail-Safe Problem	1	1
No Display/Image	1	1
Tear, Rip or Hole in Device Packaging	1	1
Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	630	630
Thrombosis/Thrombus	73	73
Obstruction/Occlusion	41	41
Insufficient Information	39	39
No Consequences Or Impact To Patient	27	27
Pain	26	26
Restenosis	21	21
Stenosis	14	14
Chest Pain	12	12
Dyspnea	11	11
Swelling/ Edema	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Device Embedded In Tissue or Plaque	9	9
No Known Impact Or Consequence To Patient	8	8
Unspecified Tissue Injury	7	7
Perforation	6	6
Swelling	5	5
Hypersensitivity/Allergic reaction	5	5
Failure of Implant	5	5
No Code Available	5	5
Injury	5	5
Foreign Body In Patient	5	5
Unintended Radiation Exposure	4	4
Unspecified Heart Problem	4	4
Stroke/CVA	4	4
Hemorrhage/Bleeding	4	4
Thrombosis	4	4
Reocclusion	4	4
Tachycardia	3	3
Cellulitis	3	3
Pulmonary Embolism	3	3
Stacking Breaths	3	3
Arrhythmia	3	3
Atrial Fibrillation	2	2
Ulcer	2	2
Local Reaction	2	2
Paralysis	2	2
Nerve Damage	2	2
Occlusion	2	2
Respiratory Insufficiency	2	2
Pancreatitis	2	2
No Patient Involvement	2	2
Pericardial Effusion	2	2
Embolism/Embolus	2	2
Foreign Body Embolism	2	2
Hematuria	1	1
Vascular Dissection	1	1
Rash	1	1
Urticaria	1	1
Rupture	1	1
Cardiac Tamponade	1	1
Perforation of Vessels	1	1
Abdominal Pain	1	1
Edema	1	1
Extravasation	1	1
Hematoma	1	1
Intimal Dissection	1	1
Inflammation	1	1
Nausea	1	1
High Blood Pressure/ Hypertension	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