TPLC - Total Product Life Cycle

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Device	iliac covered stent, arterial
Definition	For the treatment of de novo or restenotic lesions found in iliac arteries
Product Code	PRL
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
5	6	9	8	9	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	849	850
Adverse Event Without Identified Device or Use Problem	165	165
Material Deformation	145	145
Complete Blockage	132	132
Device-Device Incompatibility	114	114
Obstruction of Flow	94	94
Detachment of Device or Device Component	93	94
Premature Separation	67	69
Device Stenosis	67	67
Patient-Device Incompatibility	63	64
Failure to Advance	59	61
Migration	49	49
Retraction Problem	44	44
Collapse	40	40
Partial Blockage	39	39
Insufficient Information	39	39
Difficult to Advance	33	33
Activation, Positioning or Separation Problem	29	34
Break	28	28
Material Rupture	26	26
Deformation Due to Compressive Stress	26	26
Migration or Expulsion of Device	22	22
Difficult to Open or Remove Packaging Material	22	22
Difficult to Remove	21	21
Appropriate Term/Code Not Available	21	21
Activation Failure	21	21
Fracture	19	19
Malposition of Device	18	18
Separation Failure	17	17
Positioning Failure	16	16
Difficult to Insert	15	15
Fluid/Blood Leak	14	14
Patient Device Interaction Problem	13	13
Expiration Date Error	12	12
Inaccurate Information	12	12
Separation Problem	12	12
Material Split, Cut or Torn	12	12
Positioning Problem	11	11
Inflation Problem	11	11
Leak/Splash	10	10
Material Integrity Problem	9	9
Deflation Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Material Separation	8	9
No Apparent Adverse Event	7	8
Difficult or Delayed Separation	7	7
Packaging Problem	7	7
Inadequacy of Device Shape and/or Size	6	6
Off-Label Use	6	7
Difficult or Delayed Positioning	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1125	1153
Obstruction/Occlusion	216	216
Thrombosis/Thrombus	148	148
Stenosis	79	79
Insufficient Information	78	79
Aneurysm	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	50	50
Foreign Body In Patient	44	44
Renal Impairment	35	35
Vascular Dissection	28	28
Perforation of Vessels	26	26
Hemorrhage/Bleeding	23	23
Renal Failure	20	20
Pain	16	16
Unspecified Infection	12	12
Low Blood Pressure/ Hypotension	12	12
Ischemia	9	9
Calcium Deposits/Calcification	9	9
Unspecified Vascular Problem	8	8
Rupture	8	8
Failure of Implant	6	6
Occlusion	6	6
Pseudoaneurysm	6	6
Abdominal Pain	5	5
Restenosis	5	5
Hematoma	5	5
Embolism/Embolus	5	5
Paraplegia	4	4
Anemia	4	4
Foreign Body Embolism	3	3
Extravasation	3	3
Implant Pain	3	3
Ruptured Aneurysm	3	3
Stroke/CVA	3	3
Device Embedded In Tissue or Plaque	3	4
No Known Impact Or Consequence To Patient	2	2
Multiple Organ Failure	2	2
Perforation	2	2
Great Vessel Perforation	2	2
Exsanguination	2	2
No Code Available	2	2
Solid Tumour	2	2
Nervous System Injury	2	2
Ischemia Stroke	2	2
Fever	1	1
Paralysis	1	1
Rash	1	1
Transient Ischemic Attack	1	1
Chest Pain	1	1
Jaundice	1	1