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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	821	822
Adverse Event Without Identified Device or Use Problem	161	161
Material Deformation	142	142
Complete Blockage	123	123
Device-Device Incompatibility	112	112
Obstruction of Flow	94	94
Detachment of Device or Device Component	92	93
Premature Separation	65	67
Device Stenosis	65	65
Failure to Advance	59	61
Patient-Device Incompatibility	58	58
Migration	49	49
Retraction Problem	44	44
Collapse	39	39
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	24	24
Difficult to Open or Remove Packaging Material	22	22
Appropriate Term/Code Not Available	21	21
Activation Failure	21	21
Migration or Expulsion of Device	21	21
Difficult to Remove	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
Separation Problem	12	12
Inaccurate Information	12	12
Material Split, Cut or Torn	11	11
Positioning Problem	11	11
Inflation Problem	11	11
Leak/Splash	10	10
Deflation Problem	9	9
Material Integrity Problem	9	9
Material Separation	8	9
Improper or Incorrect Procedure or Method	8	8
Packaging Problem	7	7
Difficult or Delayed Separation	7	7
No Apparent Adverse Event	7	8
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	1095	1122
Obstruction/Occlusion	205	205
Thrombosis/Thrombus	147	147
Insufficient Information	78	79
Stenosis	75	75
Aneurysm	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Foreign Body In Patient	44	44
Renal Impairment	33	33
Vascular Dissection	28	28
Hemorrhage/Bleeding	23	23
Perforation of Vessels	22	22
Renal Failure	20	20
Pain	16	16
Unspecified Infection	12	12
Low Blood Pressure/ Hypotension	12	12
Unspecified Vascular Problem	8	8
Ischemia	8	8
Rupture	8	8
Calcium Deposits/Calcification	7	7
Failure of Implant	6	6
Occlusion	6	6
Pseudoaneurysm	6	6
Embolism/Embolus	5	5
Restenosis	4	4
Paraplegia	4	4
Device Embedded In Tissue or Plaque	3	4
Ruptured Aneurysm	3	3
Extravasation	3	3
Foreign Body Embolism	3	3
Implant Pain	3	3
Hematoma	3	3
Stroke/CVA	3	3
Abdominal Pain	3	3
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
Rash	1	1
Paralysis	1	1
Chest Pain	1	1
Jaundice	1	1
Cardiogenic Shock	1	1
Fever	1	1
Transient Ischemic Attack	1	1
Disseminated Intravascular Coagulation (DIC)	1	1