TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAQUET CARDIOVASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PECA LABS
	SUBSTANTIALLY EQUIVALENT	3
PECA LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR FLOW TECHNOLOGIES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
VASCUTEK, LTD.
	SUBSTANTIALLY EQUIVALENT	3
W. L. GORE & ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	194	194
Peeled/Delaminated	156	156
Insufficient Information	132	132
Obstruction of Flow	88	94
Material Split, Cut or Torn	82	82
Device Stenosis	58	58
Patient-Device Incompatibility	56	56
Product Quality Problem	53	53
Material Integrity Problem	52	53
Complete Blockage	46	46
Microbial Contamination of Device	45	45
Manufacturing, Packaging or Shipping Problem	44	44
Material Puncture/Hole	43	43
Material Separation	39	39
Contamination	37	37
Patient Device Interaction Problem	30	33
Fluid/Blood Leak	29	29
Appropriate Term/Code Not Available	28	30
Leak/Splash	26	26
Off-Label Use	26	26
Nonstandard Device	25	25
Partial Blockage	22	22
Use of Device Problem	20	20
Flaked	17	17
Material Perforation	16	16
Moisture or Humidity Problem	14	15
Mechanical Problem	13	13
Defective Device	13	13
Material Deformation	12	12
Migration	12	12
Material Frayed	11	11
Device Contamination with Chemical or Other Material	10	10
Material Rupture	9	9
Device Damaged Prior to Use	9	9
Infusion or Flow Problem	8	9
Shipping Damage or Problem	7	7
Detachment of Device or Device Component	6	6
Inaccurate Information	6	6
Material Fragmentation	5	5
Device Markings/Labelling Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Device Handling Problem	5	5
Contamination /Decontamination Problem	4	4
Material Twisted/Bent	4	4
Labelling, Instructions for Use or Training Problem	4	4
Difficult to Remove	3	3
Loosening of Implant Not Related to Bone-Ingrowth	3	3
Stretched	3	3
Unraveled Material	3	3
No Apparent Adverse Event	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	280	287
Thrombosis/Thrombus	166	166
Unspecified Infection	129	129
Hemorrhage/Bleeding	119	120
Obstruction/Occlusion	103	103
Stenosis	85	85
Insufficient Information	72	73
Bacterial Infection	52	52
Hematoma	46	47
No Consequences Or Impact To Patient	44	44
Seroma	37	37
Pseudoaneurysm	36	37
Occlusion	34	34
Blood Loss	33	33
No Patient Involvement	27	27
Death	23	23
No Known Impact Or Consequence To Patient	22	22
Thrombosis	22	22
No Information	19	19
No Code Available	19	19
Aneurysm	17	17
Ischemia	16	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	16
Vascular Dissection	14	14
Pain	13	14
Fever	13	13
Failure of Implant	10	10
Wound Dehiscence	10	10
Thrombus	10	10
Post Operative Wound Infection	10	10
Swelling/ Edema	9	9
Inflammation	9	9
Sepsis	8	8
Renal Failure	6	6
Failure to Anastomose	5	5
Swelling	5	5
Rupture	5	6
Heart Failure/Congestive Heart Failure	4	4
Perforation of Vessels	4	4
Ischemia Stroke	4	4
Device Embedded In Tissue or Plaque	4	4
Abdominal Pain	4	8
Hypersensitivity/Allergic reaction	4	4
Extravasation	3	3
Abscess	3	3
Purulent Discharge	3	3
Fistula	3	3
Exsanguination	3	3
Erosion	3	3
Foreign Body In Patient	3	3