TPLC - Total Product Life Cycle

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Device	system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment
Definition	An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Product Code	PFV
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
5	7	4	5	7	17	12	14	13	17	13	12	12	8	9	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	789	789
Misfire	727	727
Fracture	503	503
Break	310	310
Adverse Event Without Identified Device or Use Problem	200	200
Detachment of Device or Device Component	149	149
Material Perforation	146	146
Obstruction of Flow	125	125
Activation Failure	121	121
Material Deformation	106	106
Malposition of Device	80	80
Difficult to Remove	77	77
Complete Blockage	76	76
Loss of or Failure to Bond	74	74
Difficult or Delayed Positioning	66	66
Retraction Problem	57	57
Patient-Device Incompatibility	48	48
Insufficient Information	48	48
Positioning Problem	43	43
Difficult to Advance	41	41
Activation, Positioning or Separation Problem	36	36
Migration or Expulsion of Device	32	32
Entrapment of Device	31	31
Material Separation	30	30
Failure to Advance	30	30
Premature Activation	27	27
Device-Device Incompatibility	24	24
Difficult or Delayed Activation	22	22
Improper or Incorrect Procedure or Method	22	22
Separation Failure	20	20
Material Invagination	20	20
Occlusion Within Device	18	18
Migration	16	16
Partial Blockage	14	14
Appropriate Term/Code Not Available	14	14
Packaging Problem	13	13
Activation Problem	13	13
Failure to Unfold or Unwrap	12	12
Device Dislodged or Dislocated	11	11
Off-Label Use	10	10
Device Damaged by Another Device	9	9
Material Split, Cut or Torn	9	9
Material Twisted/Bent	9	9
Deformation Due to Compressive Stress	9	9
Leak/Splash	7	7
Device Markings/Labelling Problem	7	7
Material Fragmentation	7	7
No Apparent Adverse Event	6	6
Bent	6	6
Mechanical Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	773	773
No Clinical Signs, Symptoms or Conditions	738	738
Occlusion	137	137
No Known Impact Or Consequence To Patient	133	133
Restenosis	90	90
Stenosis	88	88
Aneurysm	46	46
No Code Available	45	45
Thrombosis	44	44
Pain	32	32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	31	31
Obstruction/Occlusion	31	31
Thrombosis/Thrombus	24	24
Unspecified Infection	23	23
Injury	22	22
Foreign Body In Patient	21	21
Device Embedded In Tissue or Plaque	20	20
Death	20	20
Hemorrhage/Bleeding	20	20
Perforation of Vessels	20	20
No Information	19	19
Pseudoaneurysm	19	19
Ischemia	16	16
No Patient Involvement	15	15
Thrombus	15	15
Embolism	12	12
Blood Loss	12	12
Perforation	10	10
Insufficient Information	9	9
Claudication	9	9
Vascular Dissection	8	8
Thromboembolism	8	8
Fistula	8	8
Vascular System (Circulation), Impaired	7	7
Hematoma	7	7
Sepsis	6	6
Unspecified Tissue Injury	5	5
Bacterial Infection	5	5
Swelling/ Edema	4	4
Extravasation	4	4
Not Applicable	4	4
Numbness	4	4
Encephalopathy	4	4
Multiple Organ Failure	3	3
Device Overstimulation of Tissue	3	3
Rupture	3	3
Renal Failure	3	3
Skin Erosion	3	3
Reocclusion	2	2
Abscess	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Feb-09-2023