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)
2021	2022	2023	2024	2025	2026
12	8	9	5	11	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Misfire	485	485
Positioning Failure	376	376
Fracture	241	242
Break	222	222
Adverse Event Without Identified Device or Use Problem	152	155
Material Deformation	126	126
Activation Failure	93	93
Detachment of Device or Device Component	86	86
Loss of or Failure to Bond	75	75
Material Perforation	53	53
Obstruction of Flow	52	52
Malposition of Device	45	45
Difficult to Remove	31	31
Difficult or Delayed Positioning	31	31
Failure to Advance	20	20
Positioning Problem	19	19
Difficult to Advance	18	18
Retraction Problem	17	17
Material Separation	15	15
Device-Device Incompatibility	12	12
Entrapment of Device	11	11
Migration	11	11
Packaging Problem	11	11
Migration or Expulsion of Device	10	10
Physical Resistance/Sticking	10	10
Premature Activation	9	9
Material Invagination	9	9
Material Twisted/Bent	9	9
Activation Problem	7	7
Insufficient Information	7	7
Improper or Incorrect Procedure or Method	6	6
Device Markings/Labelling Problem	6	6
Device Stenosis	6	7
Complete Blockage	6	6
Off-Label Use	5	5
Device Contamination with Chemical or Other Material	5	5
Shipping Damage or Problem	5	5
Patient-Device Incompatibility	4	4
Difficult or Delayed Activation	4	4
Deformation Due to Compressive Stress	3	3
Material Fragmentation	3	3
Separation Failure	3	3
Material Puncture/Hole	3	3
Difficult or Delayed Separation	2	2
Partial Blockage	2	3
Microbial Contamination of Device	2	2
Tear, Rip or Hole in Device Packaging	2	2
Defective Component	2	2
Missing Information	2	2
Device Damaged Prior to Use	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	940	940
Restenosis	103	104
Stenosis	34	35
Obstruction/Occlusion	34	36
Thrombosis/Thrombus	32	32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	30
Pain	17	17
Aneurysm	15	15
Foreign Body In Patient	15	15
Insufficient Information	13	13
Swelling/ Edema	11	11
Hemorrhage/Bleeding	10	10
Hematoma	7	7
Bacterial Infection	5	5
Unspecified Tissue Injury	5	5
Ischemia	5	5
Failure of Implant	4	4
Perforation of Vessels	3	3
Extravasation	3	3
Skin Erosion	3	3
Renal Impairment	2	2
Embolism/Embolus	2	2
Perforation	2	2
Vascular Dissection	2	2
Hypersensitivity/Allergic reaction	2	2
Pseudoaneurysm	2	2
No Consequences Or Impact To Patient	2	2
Unspecified Infection	2	2
Device Embedded In Tissue or Plaque	2	2
No Known Impact Or Consequence To Patient	1	2
Rupture	1	1
No Patient Involvement	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Numbness	1	1
Implant Pain	1	1
Abscess	1	1
Skin Inflammation/ Irritation	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Occlusion	1	1
Wound Dehiscence	1	1
Skin Infection	1	1
Thrombus	1	1
Urinary Tract Infection	1	1
Fistula	1	1

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