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)
2020	2021	2022	2023	2024	2025
6	5	6	9	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	760	761
Adverse Event Without Identified Device or Use Problem	169	169
Device-Device Incompatibility	123	123
Material Deformation	123	123
Complete Blockage	120	120
Detachment of Device or Device Component	95	96
Obstruction of Flow	88	88
Patient-Device Incompatibility	70	70
Failure to Advance	61	61
Device Stenosis	58	58
Premature Separation	54	54
Retraction Problem	51	51
Collapse	51	51
Migration	51	51
Insufficient Information	39	39
Partial Blockage	33	33
Difficult to Advance	33	33
Material Rupture	28	28
Activation, Positioning or Separation Problem	28	33
Break	26	26
Deformation Due to Compressive Stress	24	24
Difficult to Remove	22	22
Difficult to Open or Remove Packaging Material	22	22
Fracture	21	21
Appropriate Term/Code Not Available	21	21
Migration or Expulsion of Device	20	20
Positioning Failure	20	20
Activation Failure	17	17
Separation Failure	17	17
Malposition of Device	17	17
Patient Device Interaction Problem	15	15
Difficult to Insert	15	15
Deflation Problem	14	14
Material Split, Cut or Torn	13	13
Inaccurate Information	12	12
Expiration Date Error	12	12
Separation Problem	12	12
Fluid/Blood Leak	12	12
Inflation Problem	12	12
Material Separation	11	12
Positioning Problem	11	11
Packaging Problem	11	11
Leak/Splash	11	11
Material Integrity Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Material Invagination	7	8
Inadequacy of Device Shape and/or Size	7	7
No Apparent Adverse Event	6	7
Off-Label Use	6	7
Difficult or Delayed Separation	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	981	996
Obstruction/Occlusion	187	187
Thrombosis/Thrombus	137	137
Stenosis	72	72
Insufficient Information	70	71
Aneurysm	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	54
No Consequences Or Impact To Patient	43	43
Occlusion	36	37
Foreign Body In Patient	35	35
Vascular Dissection	26	26
No Code Available	24	24
Perforation of Vessels	24	24
Renal Failure	24	24
Renal Impairment	23	23
No Known Impact Or Consequence To Patient	21	21
Hemorrhage/Bleeding	19	19
Pain	15	15
Unspecified Infection	13	13
No Patient Involvement	13	13
Low Blood Pressure/ Hypotension	12	12
Ischemia	11	11
Unspecified Vascular Problem	8	8
Death	7	7
Pseudoaneurysm	7	7
Calcium Deposits/Calcification	6	6
Failure of Implant	6	6
Rupture	5	5
Restenosis	4	4
Device Embedded In Tissue or Plaque	4	5
Injury	4	4
Paraplegia	4	4
Blood Loss	3	3
Thrombus	3	3
Abdominal Pain	3	3
Stroke/CVA	3	3
Implant Pain	3	3
Foreign Body Embolism	3	3
Ruptured Aneurysm	3	3
Perforation	3	3
Hematoma	3	3
Nervous System Injury	2	2
Solid Tumour	2	2
Great Vessel Perforation	2	2
No Information	2	2
Extravasation	2	2
Exsanguination	2	2
Claudication	2	2
Embolism/Embolus	2	2
Thrombosis	2	2