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
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	1
1. K241070 Gelsoft™ Plus Vascular Prostheses
2. K241550 Gelweave™ Vascular Prostheses
VASCUTEK LTD.
	SUBSTANTIALLY EQUIVALENT	2
1. K241070 Gelsoft™ Plus Vascular Prostheses
2. K241550 Gelweave™ Vascular Prostheses
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	125	125
Peeled/Delaminated	121	121
Obstruction of Flow	78	78
Insufficient Information	68	68
Material Split, Cut or Torn	63	63
Patient-Device Incompatibility	47	47
Device Stenosis	44	44
Complete Blockage	42	42
Material Integrity Problem	40	41
Contamination	37	37
Microbial Contamination of Device	37	37
Material Puncture/Hole	35	35
Material Separation	35	35
Product Quality Problem	30	30
Nonstandard Device	24	24
Patient Device Interaction Problem	24	24
Off-Label Use	21	21
Partial Blockage	21	21
Fluid/Blood Leak	18	18
Flaked	17	17
Use of Device Problem	16	16
Appropriate Term/Code Not Available	15	15
Leak/Splash	15	15
Defective Device	13	13
Manufacturing, Packaging or Shipping Problem	13	13
Migration	12	12
Material Perforation	12	12
Material Deformation	11	11
Mechanical Problem	9	9
Device Damaged Prior to Use	9	9
Material Frayed	9	9
Material Rupture	8	8
Infusion or Flow Problem	8	8
Inaccurate Information	6	6
Device Markings/Labelling Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Material Fragmentation	5	5
Device Contamination with Chemical or Other Material	4	4
Detachment of Device or Device Component	4	4
Labelling, Instructions for Use or Training Problem	4	4
Contamination /Decontamination Problem	4	4
Shipping Damage or Problem	4	4
Material Twisted/Bent	4	4
Human-Device Interface Problem	3	3
No Apparent Adverse Event	3	3
Deformation Due to Compressive Stress	3	3
Packaging Problem	3	3
Disconnection	3	3
Compatibility Problem	3	3
Component Missing	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	239	241
Thrombosis/Thrombus	137	137
Hemorrhage/Bleeding	105	106
Obstruction/Occlusion	87	87
Insufficient Information	67	67
Unspecified Infection	61	61
Stenosis	56	56
Bacterial Infection	44	44
Hematoma	39	39
Pseudoaneurysm	30	30
Seroma	25	25
No Consequences Or Impact To Patient	21	21
Occlusion	19	19
Thrombosis	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Vascular Dissection	14	14
Ischemia	14	14
No Code Available	13	13
Fever	12	12
No Patient Involvement	12	12
Aneurysm	11	11
Wound Dehiscence	10	10
Pain	9	9
Post Operative Wound Infection	9	9
Failure of Implant	9	9
Thrombus	8	8
Blood Loss	8	8
Sepsis	7	7
Swelling/ Edema	6	6
Inflammation	6	6
Death	6	6
No Information	5	5
Rupture	5	5
Failure to Anastomose	5	5
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	4
Erosion	3	3
Perforation of Vessels	3	3
Renal Failure	3	3
Purulent Discharge	3	3
Abscess	3	3
Fistula	3	3
Foreign Body In Patient	3	3
Myocardial Infarction	2	2
Thromboembolism	2	2
Unspecified Vascular Problem	2	2
Unspecified Kidney or Urinary Problem	2	2