TPLC - Total Product Life Cycle

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Device	prosthesis, vascular graft, of 6mm and greater diameter
Product Code	DSY
Regulation Number	870.3450
Device Class	2

Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PECA LABS
	SUBSTANTIALLY EQUIVALENT	3
1. K233783 exGraft ePTFE Vascular Grafts, exGraft Carbon ePTF ...
PECA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K233783 exGraft ePTFE Vascular Grafts, exGraft Carbon ePTF ...
VASCUTEK LTD
	SUBSTANTIALLY EQUIVALENT	1
VASCUTEK LTD.
	SUBSTANTIALLY EQUIVALENT	1
W. L. GORE & ASSOCIATES INC.
	SUBSTANTIALLY EQUIVALENT	1
W. L. GORE & ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	2
W.L. GORE & ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	142	142
Insufficient Information	108	108
Peeled/Delaminated	93	93
Obstruction of Flow	73	73
Material Split, Cut or Torn	64	64
Patient-Device Incompatibility	50	50
Material Integrity Problem	47	47
Complete Blockage	43	43
Microbial Contamination of Device	42	42
Material Puncture/Hole	41	41
Contamination	37	37
Product Quality Problem	36	36
Manufacturing, Packaging or Shipping Problem	36	36
Material Separation	32	32
Nonstandard Device	25	25
Patient Device Interaction Problem	24	24
Appropriate Term/Code Not Available	22	22
Partial Blockage	21	21
Use of Device Problem	20	20
Off-Label Use	20	20
Leak/Splash	18	18
Flaked	16	16
Device Stenosis	15	15
Material Perforation	14	14
Mechanical Problem	13	13
Fluid/Blood Leak	13	13
Material Deformation	12	12
Defective Device	9	9
Migration	9	9
Device Damaged Prior to Use	9	9
Infusion or Flow Problem	8	8
Shipping Damage or Problem	7	7
Detachment of Device or Device Component	6	6
Inaccurate Information	5	5
Material Fragmentation	5	5
Device Handling Problem	5	5
Material Rupture	5	5
Material Frayed	5	5
Device Contamination with Chemical or Other Material	4	4
Contamination /Decontamination Problem	4	4
Improper or Incorrect Procedure or Method	4	4
No Apparent Adverse Event	3	3
Human-Device Interface Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Packaging Problem	3	3
Deformation Due to Compressive Stress	3	3
Compatibility Problem	3	3
Material Twisted/Bent	3	3
Unraveled Material	3	3
Stretched	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	192	192
Unspecified Infection	119	119
Thrombosis/Thrombus	101	101
Hemorrhage/Bleeding	84	84
Obstruction/Occlusion	55	55
Stenosis	45	45
No Consequences Or Impact To Patient	44	44
Bacterial Infection	44	44
Insufficient Information	43	43
Hematoma	37	37
Occlusion	34	34
Blood Loss	33	33
Seroma	29	29
Pseudoaneurysm	29	29
No Patient Involvement	27	27
Death	23	23
Thrombosis	22	22
No Known Impact Or Consequence To Patient	22	22
No Code Available	19	19
No Information	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Aneurysm	15	15
Ischemia	14	14
Vascular Dissection	13	13
Pain	10	10
Post Operative Wound Infection	10	10
Thrombus	10	10
Inflammation	9	9
Wound Dehiscence	8	8
Failure of Implant	7	7
Sepsis	6	6
Renal Failure	6	6
Failure to Anastomose	5	5
Swelling	5	5
Swelling/ Edema	4	4
Rupture	4	4
Perforation of Vessels	4	4
Heart Failure/Congestive Heart Failure	4	4
Fever	4	4
Ischemia Stroke	4	4
Abdominal Pain	4	4
Erosion	3	3
Purulent Discharge	3	3
Hypersensitivity/Allergic reaction	3	3
Foreign Body In Patient	3	3
Fistula	3	3
Myocardial Infarction	2	2
Embolism	2	2
Thromboembolism	2	2
Unspecified Vascular Problem	2	2