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	2
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	159	159
Peeled/Delaminated	141	141
Obstruction of Flow	82	88
Insufficient Information	75	75
Material Split, Cut or Torn	67	67
Device Stenosis	58	58
Patient-Device Incompatibility	50	50
Complete Blockage	43	43
Product Quality Problem	41	41
Material Integrity Problem	41	42
Microbial Contamination of Device	38	38
Material Separation	37	37
Contamination	37	37
Material Puncture/Hole	35	35
Fluid/Blood Leak	28	28
Nonstandard Device	24	24
Patient Device Interaction Problem	24	27
Off-Label Use	23	23
Partial Blockage	21	21
Manufacturing, Packaging or Shipping Problem	19	19
Leak/Splash	18	18
Flaked	17	17
Appropriate Term/Code Not Available	17	19
Use of Device Problem	16	16
Moisture or Humidity Problem	14	15
Defective Device	13	13
Migration	12	12
Material Perforation	12	12
Material Deformation	11	11
Device Contamination with Chemical or Other Material	10	10
Material Frayed	10	10
Device Damaged Prior to Use	9	9
Mechanical Problem	9	9
Material Rupture	9	9
Infusion or Flow Problem	8	9
Inaccurate Information	6	6
Device Markings/Labelling Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Material Fragmentation	5	5
Detachment of Device or Device Component	4	4
Contamination /Decontamination Problem	4	4
Shipping Damage or Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Material Twisted/Bent	4	4
No Apparent Adverse Event	3	3
Deformation Due to Compressive Stress	3	5
Disconnection	3	3
Human-Device Interface Problem	3	3
Packaging Problem	3	3
Compatibility Problem	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
Hemorrhage/Bleeding	118	119
Obstruction/Occlusion	103	103
Insufficient Information	72	73
Stenosis	68	68
Unspecified Infection	64	64
Bacterial Infection	49	49
Hematoma	41	42
Pseudoaneurysm	34	35
Seroma	30	30
No Consequences Or Impact To Patient	21	21
Occlusion	19	19
Thrombosis	17	17
Ischemia	16	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	16
Vascular Dissection	14	14
Aneurysm	13	13
No Code Available	13	13
Fever	12	12
No Patient Involvement	12	12
Pain	12	13
Wound Dehiscence	10	10
Post Operative Wound Infection	9	9
Swelling/ Edema	9	9
Failure of Implant	9	9
Thrombus	8	8
Blood Loss	8	8
Sepsis	7	7
Inflammation	6	6
Death	6	6
No Information	5	5
Failure to Anastomose	5	5
Rupture	5	6
Heart Failure/Congestive Heart Failure	4	4
Hypersensitivity/Allergic reaction	4	4
Ischemia Stroke	4	4
Device Embedded In Tissue or Plaque	4	4
Abdominal Pain	4	8
Perforation of Vessels	3	3
Renal Failure	3	3
Extravasation	3	3
Abscess	3	3
Erosion	3	3
Foreign Body In Patient	3	3
Fistula	3	3
Purulent Discharge	3	3
Cellulitis	2	2
No Known Impact Or Consequence To Patient	2	2
High Blood Pressure/ Hypertension	2	2