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	1
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
Peeled/Delaminated	132	132
Adverse Event Without Identified Device or Use Problem	116	116
Insufficient Information	67	67
Obstruction of Flow	61	61
Device Stenosis	57	57
Material Split, Cut or Torn	50	50
Microbial Contamination of Device	34	34
Product Quality Problem	34	34
Complete Blockage	33	33
Material Integrity Problem	32	33
Material Separation	31	31
Patient-Device Incompatibility	29	29
Material Puncture/Hole	26	26
Contamination	24	24
Patient Device Interaction Problem	22	25
Off-Label Use	21	21
Nonstandard Device	21	21
Fluid/Blood Leak	19	19
Partial Blockage	18	18
Appropriate Term/Code Not Available	16	18
Flaked	13	13
Use of Device Problem	13	13
Defective Device	12	12
Material Deformation	11	11
Manufacturing, Packaging or Shipping Problem	11	11
Leak/Splash	10	10
Migration	10	10
Material Frayed	9	9
Device Damaged Prior to Use	9	9
Material Perforation	7	7
Infusion or Flow Problem	6	7
Material Rupture	5	5
Improper or Incorrect Procedure or Method	5	5
Inaccurate Information	5	5
Mechanical Problem	4	4
Device Markings/Labelling Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Contamination /Decontamination Problem	4	4
Material Fragmentation	4	4
Material Twisted/Bent	4	4
Detachment of Device or Device Component	3	3
No Apparent Adverse Event	3	3
Human-Device Interface Problem	3	3
Deformation Due to Compressive Stress	3	5
Disconnection	3	3
Tear, Rip or Hole in Device Packaging	2	2
Device Contamination with Chemical or Other Material	2	2
Activation Failure	2	2
Missing Information	2	2
Device Appears to Trigger Rejection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	231	236
Thrombosis/Thrombus	141	141
Hemorrhage/Bleeding	104	105
Obstruction/Occlusion	100	100
Insufficient Information	66	66
Stenosis	62	62
Unspecified Infection	38	38
Bacterial Infection	38	38
Hematoma	33	33
Pseudoaneurysm	28	29
Seroma	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	16
Ischemia	13	13
Fever	12	12
Vascular Dissection	12	12
Failure of Implant	9	9
Post Operative Wound Infection	8	8
Wound Dehiscence	8	8
Aneurysm	8	8
Sepsis	6	6
Swelling/ Edema	6	6
Failure to Anastomose	5	5
Pain	4	5
Rupture	4	5
Heart Failure/Congestive Heart Failure	4	4
Inflammation	4	4
Hypersensitivity/Allergic reaction	4	4
Ischemia Stroke	4	4
Abdominal Pain	4	8
Device Embedded In Tissue or Plaque	4	4
No Consequences Or Impact To Patient	3	3
Abscess	3	3
Erosion	3	3
Purulent Discharge	3	3
No Patient Involvement	3	3
Perforation of Vessels	2	2
Unspecified Vascular Problem	2	2
Thromboembolism	2	2
Dyspnea	2	2
Paresis	2	2
Low Blood Pressure/ Hypotension	2	2
Unspecified Kidney or Urinary Problem	2	2
Unspecified Hepatic or Biliary Problem	2	2
Chest Pain	2	2
Quadriplegia	2	2
Fistula	2	2
Rash	2	2
Syncope/Fainting	2	2
Cellulitis	2	2
Local Reaction	2	2