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)
2021	2022	2023	2024	2025	2026
11	5	7	9	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	348	348
Adverse Event Without Identified Device or Use Problem	202	202
Material Deformation	109	109
Migration	91	91
Activation, Positioning or Separation Problem	73	73
Fracture	70	72
Improper or Incorrect Procedure or Method	53	53
Migration or Expulsion of Device	42	42
Positioning Failure	40	40
Off-Label Use	40	41
Obstruction of Flow	39	40
Malposition of Device	29	29
Detachment of Device or Device Component	28	28
Use of Device Problem	27	27
Difficult to Remove	23	23
Break	23	23
Misfire	21	21
Deformation Due to Compressive Stress	21	21
Premature Activation	19	19
Entrapment of Device	17	17
Difficult or Delayed Positioning	17	17
Difficult to Advance	16	16
Material Twisted/Bent	10	10
Device Markings/Labelling Problem	9	9
Device Damaged by Another Device	9	9
Physical Resistance/Sticking	9	9
Positioning Problem	8	8
Loss of or Failure to Bond	8	8
Nonstandard Device	7	7
No Apparent Adverse Event	7	7
Packaging Problem	7	7
Device-Device Incompatibility	7	7
Device Dislodged or Dislocated	6	6
Difficult or Delayed Activation	6	6
Structural Problem	6	6
Failure to Advance	5	5
Defective Device	4	4
Material Fragmentation	4	4
Activation Problem	4	4
Biocompatibility	3	3
Delivered as Unsterile Product	3	3
Mechanical Problem	3	3
Device Damaged Prior to Use	3	3
Incomplete or Missing Packaging	3	3
Material Too Rigid or Stiff	2	2
Stretched	2	2
Material Separation	2	2
Appropriate Term/Code Not Available	2	2
Failure to Eject	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	717	717
Thrombosis/Thrombus	111	112
Obstruction/Occlusion	73	73
Insufficient Information	69	70
Pain	51	51
Restenosis	40	40
Stenosis	30	30
Swelling/ Edema	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Chest Pain	14	14
Dyspnea	12	12
Foreign Body In Patient	10	10
Pulmonary Embolism	9	9
Hematoma	8	8
Hemorrhage/Bleeding	8	8
Hypersensitivity/Allergic reaction	8	8
Unspecified Tissue Injury	7	7
Device Embedded In Tissue or Plaque	7	7
Perforation	6	6
Numbness	6	6
Ulcer	5	5
Failure of Implant	5	5
Unspecified Infection	5	5
Unspecified Heart Problem	4	4
Stroke/CVA	4	4
Local Reaction	4	4
Unintended Radiation Exposure	4	4
Embolism/Embolus	3	3
Perforation of Vessels	3	3
Tachycardia	3	3
Arrhythmia	3	3
Stacking Breaths	3	3
Rupture	3	3
Low Blood Pressure/ Hypotension	3	3
Pericardial Effusion	3	3
Cellulitis	3	3
Rash	3	3
Pseudoaneurysm	2	2
Respiratory Insufficiency	2	2
Foreign Body Embolism	2	2
Nerve Damage	2	2
Paralysis	2	2
Fever	2	2
Paresthesia	2	2
Atrial Fibrillation	2	2
Anemia	2	2
No Code Available	2	2
Nausea	2	2
Pancreatitis	2	2
Cardiac Arrest	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	Jan-15-2026
4	Medtronic Inc.	II	Mar-19-2024
5	Medtronic Inc.	II	May-05-2021
6	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jan-06-2022