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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	0	0	0	7	14	9	6	5	6	9	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	690	690
Device-Device Incompatibility	139	139
Adverse Event Without Identified Device or Use Problem	125	125
Complete Blockage	86	86
Obstruction of Flow	81	81
Detachment of Device or Device Component	66	66
Patient-Device Incompatibility	64	64
Material Deformation	54	54
Failure to Advance	51	51
Migration	41	41
Retraction Problem	40	40
Collapse	37	37
Premature Separation	36	36
Insufficient Information	32	32
Device Stenosis	30	30
Activation, Positioning or Separation Problem	28	28
Migration or Expulsion of Device	24	24
Material Rupture	23	23
Partial Blockage	22	22
Difficult to Advance	22	22
Break	21	21
Material Split, Cut or Torn	17	17
Difficult to Remove	17	17
Difficult to Insert	15	15
Difficult to Open or Remove Packaging Material	15	15
Deformation Due to Compressive Stress	15	15
Appropriate Term/Code Not Available	15	15
Patient Device Interaction Problem	14	14
Occlusion Within Device	14	14
Separation Failure	13	13
Inflation Problem	13	13
Deflation Problem	12	12
Malposition of Device	12	12
Separation Problem	12	12
Positioning Failure	12	12
Physical Resistance	11	11
Positioning Problem	11	11
Fracture	11	11
Leak/Splash	11	11
Fluid/Blood Leak	10	10
Material Separation	9	9
Improper or Incorrect Procedure or Method	8	8
Packaging Problem	8	8
Activation Failure	8	8
No Apparent Adverse Event	8	8
Inadequacy of Device Shape and/or Size	7	7
Material Invagination	6	6
Detachment Of Device Component	6	6
Physical Resistance/Sticking	5	5
Unintended Movement	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	626	626
No Consequences Or Impact To Patient	181	181
Obstruction/Occlusion	136	136
Thrombosis/Thrombus	83	83
No Known Impact Or Consequence To Patient	73	73
Stenosis	67	67
Aneurysm	60	60
No Patient Involvement	56	56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Occlusion	40	40
Insufficient Information	39	39
No Code Available	28	28
Foreign Body In Patient	23	23
Renal Failure	21	21
Vascular Dissection	20	20
Death	17	17
Renal Impairment	17	17
Pain	15	15
Perforation of Vessels	14	14
Hemorrhage/Bleeding	13	13
Injury	12	12
Unspecified Infection	10	10
No Information	9	9
Ischemia	9	9
Unspecified Vascular Problem	8	8
Failure of Implant	7	7
Calcium Deposits/Calcification	6	6
Claudication	6	6
Thrombus	5	5
Device Embedded In Tissue or Plaque	4	4
Pseudoaneurysm	4	4
Restenosis	3	3
Paraplegia	3	3
Ruptured Aneurysm	3	3
Rupture	3	3
Blood Loss	3	3
Hematoma	3	3
Perforation	3	3
Abdominal Pain	3	3
Thrombosis	2	2
Rash	2	2
Foreign Body Embolism	2	2
Exsanguination	2	2
Embolism	2	2
Solid Tumour	2	2
Stroke/CVA	2	2
Low Blood Pressure/ Hypotension	2	2
Nervous System Injury	2	2
Ambulation Difficulties	2	2
Cardiogenic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Nov-11-2023
2	Bard Peripheral Vascular Inc	II	Dec-19-2019
3	W L Gore & Associates, Inc.	II	Aug-30-2024
4	W L Gore & Associates, Inc.	II	Oct-08-2021