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	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	343	343
Adverse Event Without Identified Device or Use Problem	218	218
Material Deformation	116	116
Migration	84	84
Activation, Positioning or Separation Problem	74	74
Fracture	70	71
Improper or Incorrect Procedure or Method	53	53
Positioning Failure	42	42
Migration or Expulsion of Device	40	40
Off-Label Use	40	41
Obstruction of Flow	38	38
Malposition of Device	32	32
Detachment of Device or Device Component	29	29
Use of Device Problem	27	27
Difficult to Remove	25	25
Break	23	23
Misfire	23	23
Deformation Due to Compressive Stress	21	21
Premature Activation	19	19
Difficult to Advance	17	17
Difficult or Delayed Positioning	16	16
Entrapment of Device	15	15
Loss of or Failure to Bond	10	10
Material Twisted/Bent	10	10
Device Markings/Labelling Problem	9	9
Positioning Problem	9	9
Device Damaged by Another Device	9	9
Physical Resistance/Sticking	8	8
Packaging Problem	8	8
Device-Device Incompatibility	7	7
No Apparent Adverse Event	7	7
Device Dislodged or Dislocated	6	6
Difficult or Delayed Activation	6	6
Structural Problem	6	6
Nonstandard Device	5	5
Failure to Advance	5	5
Defective Device	4	4
Material Fragmentation	4	4
Biocompatibility	3	3
Delivered as Unsterile Product	3	3
Device Damaged Prior to Use	3	3
Activation Problem	3	3
Incomplete or Missing Packaging	3	3
Material Too Rigid or Stiff	2	2
Stretched	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Mechanical Problem	2	2
Sharp Edges	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	736	736
Thrombosis/Thrombus	113	114
Obstruction/Occlusion	76	76
Insufficient Information	69	70
Pain	53	53
Restenosis	42	42
Stenosis	36	36
Swelling/ Edema	21	21
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	14	14
Chest Pain	14	14
Dyspnea	12	12
Foreign Body In Patient	10	10
Pulmonary Embolism	9	9
Hypersensitivity/Allergic reaction	8	8
Hemorrhage/Blood Loss/Bleeding	8	8
Hematoma	8	8
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	7	7
Perforation	6	6
Numbness	6	6
Unspecified Infection	5	5
Low Blood Pressure/ Hypotension	5	5
Ulcer	5	5
Failure of Implant	5	5
Embolism/Embolus	5	5
Unintended Radiation Exposure	4	4
Unspecified Heart Problem	4	4
Stroke/CVA	4	4
Local Reaction	4	4
Shaking/Tremors	3	3
Perforation of Vessels	3	3
Tachycardia	3	3
Burning Sensation	3	3
Rash	3	3
Cellulitis	3	3
Superficial (First Degree) Burn	3	3
Pericardial Effusion	3	3
Rupture	3	3
Cholangitis	3	3
Stacking Breaths	3	3
Arrhythmia	3	3
Paresthesia	2	2
Fever	2	2
Paralysis	2	2
Atrial Fibrillation	2	2
Anemia	2	2
Nerve Damage	2	2
Foreign Body Embolism	2	2
Respiratory Insufficiency	2	2
Pseudoaneurysm	2	2

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