TPLC - Total Product Life Cycle

show TPLC since

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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	733	734
Adverse Event Without Identified Device or Use Problem	153	153
Material Deformation	122	122
Complete Blockage	108	108
Device-Device Incompatibility	106	106
Obstruction of Flow	88	88
Detachment of Device or Device Component	84	85
Device Stenosis	59	59
Premature Separation	55	55
Failure to Advance	54	54
Patient-Device Incompatibility	54	54
Migration	46	46
Retraction Problem	44	44
Collapse	39	39
Insufficient Information	35	35
Partial Blockage	29	29
Difficult to Advance	29	29
Activation, Positioning or Separation Problem	28	33
Material Rupture	26	26
Break	24	24
Difficult to Open or Remove Packaging Material	22	22
Difficult to Remove	21	21
Migration or Expulsion of Device	20	20
Appropriate Term/Code Not Available	19	19
Fracture	19	19
Deformation Due to Compressive Stress	18	18
Activation Failure	18	18
Separation Failure	17	17
Malposition of Device	16	16
Positioning Failure	16	16
Difficult to Insert	15	15
Patient Device Interaction Problem	13	13
Fluid/Blood Leak	12	12
Inaccurate Information	12	12
Expiration Date Error	12	12
Separation Problem	11	11
Material Split, Cut or Torn	11	11
Positioning Problem	10	10
Leak/Splash	10	10
Material Integrity Problem	9	9
Deflation Problem	9	9
Inflation Problem	9	9
Material Separation	8	9
Improper or Incorrect Procedure or Method	7	7
Packaging Problem	7	7
No Apparent Adverse Event	6	7
Inadequacy of Device Shape and/or Size	6	6
Off-Label Use	6	7
Difficult or Delayed Separation	6	6
Material Invagination	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	984	999
Obstruction/Occlusion	187	187
Thrombosis/Thrombus	139	139
Insufficient Information	69	70
Stenosis	65	65
Aneurysm	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Foreign Body In Patient	39	39
Renal Impairment	26	26
Vascular Dissection	25	25
Perforation of Vessels	22	22
Renal Failure	20	20
Hemorrhage/Bleeding	19	19
Pain	14	14
Unspecified Infection	12	12
Low Blood Pressure/ Hypotension	12	12
Unspecified Vascular Problem	8	8
Ischemia	7	7
Failure of Implant	6	6
Occlusion	6	6
Calcium Deposits/Calcification	6	6
Pseudoaneurysm	5	5
Rupture	5	5
Restenosis	4	4
Paraplegia	4	4
Foreign Body Embolism	3	3
Implant Pain	3	3
Hematoma	3	3
Ruptured Aneurysm	3	3
Stroke/CVA	3	3
Device Embedded In Tissue or Plaque	3	4
Abdominal Pain	3	3
No Known Impact Or Consequence To Patient	2	2
Multiple Organ Failure	2	2
Extravasation	2	2
Embolism/Embolus	2	2
Perforation	2	2
Exsanguination	2	2
Great Vessel Perforation	2	2
No Code Available	2	2
Solid Tumour	2	2
Nervous System Injury	2	2
Transient Ischemic Attack	1	1
Fever	1	1
Paralysis	1	1
Rash	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Chest Pain	1	1
Jaundice	1	1
Cardiogenic Shock	1	1