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)
2018	2019	2020	2021	2022	2023
0	4	10	11	5	6

MDR Year	MDR Reports	MDR Events
2019	24	24
2020	117	117
2021	425	425
2022	115	115
2023	178	178

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	386	386
Adverse Event Without Identified Device or Use Problem	107	107
Migration	79	79
Material Deformation	69	69
Activation, Positioning or Separation Problem	53	53
Fracture	51	51
Improper or Incorrect Procedure or Method	39	39
Migration or Expulsion of Device	32	32
Positioning Failure	30	30
Off-Label Use	29	29
Entrapment of Device	28	28
Difficult to Remove	23	23
Misfire	23	23
Difficult or Delayed Positioning	19	19
Malposition of Device	18	18
Break	17	17
Deformation Due to Compressive Stress	16	16
Use of Device Problem	14	14
Detachment of Device or Device Component	14	14
Obstruction of Flow	11	11
Material Twisted/Bent	9	9
No Apparent Adverse Event	8	8
Premature Activation	8	8
Device Damaged by Another Device	7	7
Positioning Problem	7	7
Physical Resistance/Sticking	7	7
Device Markings/Labelling Problem	6	6
Device-Device Incompatibility	6	6
Difficult to Advance	5	5
Structural Problem	5	5
Loss of or Failure to Bond	5	5
Material Fragmentation	4	4
Mechanical Problem	4	4
Appropriate Term/Code Not Available	4	4
Material Integrity Problem	3	3
Activation Problem	3	3
Nonstandard Device	3	3
Failure to Advance	3	3
Device Damaged Prior to Use	3	3
Stretched	2	2
Difficult or Delayed Activation	2	2
Defective Device	2	2
Retraction Problem	2	2
Material Too Rigid or Stiff	2	2
Material Separation	2	2
Inaccurate Information	2	2
Human-Device Interface Problem	2	2
Compatibility Problem	1	1
Material Protrusion/Extrusion	1	1
Mechanical Jam	1	1
Insufficient Information	1	1
Inadequacy of Device Shape and/or Size	1	1
Poor Quality Image	1	1
Labelling, Instructions for Use or Training Problem	1	1
No Display/Image	1	1
Tear, Rip or Hole in Device Packaging	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Dislodged or Dislocated	1	1
Device Contamination with Chemical or Other Material	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	592	592
Thrombosis/Thrombus	65	65
Obstruction/Occlusion	41	41
Insufficient Information	37	37
No Consequences Or Impact To Patient	27	27
Pain	24	24
Restenosis	19	19
Stenosis	13	13
Chest Pain	11	11
Swelling/ Edema	11	11
Device Embedded In Tissue or Plaque	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Dyspnea	9	9
No Known Impact Or Consequence To Patient	8	8
Unspecified Tissue Injury	7	7
Foreign Body In Patient	5	5
No Code Available	5	5
Hypersensitivity/Allergic reaction	5	5
Failure of Implant	5	5
Injury	5	5
Perforation	5	5
Swelling	5	5
Thrombosis	4	4
Reocclusion	4	4
Stroke/CVA	4	4
Hemorrhage/Bleeding	4	4
Unintended Radiation Exposure	4	4
Unspecified Heart Problem	4	4
Cellulitis	3	3
Pulmonary Embolism	3	3
Stacking Breaths	3	3
Arrhythmia	3	3
Tachycardia	3	3
Paralysis	2	2
Nerve Damage	2	2
Occlusion	2	2
Ulcer	2	2
Atrial Fibrillation	2	2
Respiratory Insufficiency	2	2
Pancreatitis	2	2
Pericardial Effusion	2	2
Embolism/Embolus	2	2
Foreign Body Embolism	2	2
No Patient Involvement	2	2
Vascular Dissection	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
Urticaria	1	1
Rupture	1	1
Cardiac Tamponade	1	1
Hematuria	1	1
Perforation of Vessels	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	May-05-2021
4	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	II	Jan-06-2022