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	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
Adverse Event Without Identified Device or Use Problem	140	140
Peeled/Delaminated	133	133
Insufficient Information	74	74
Obstruction of Flow	64	70
Device Stenosis	58	58
Material Split, Cut or Torn	52	52
Product Quality Problem	39	39
Complete Blockage	34	34
Microbial Contamination of Device	34	34
Material Separation	32	32
Material Integrity Problem	32	33
Patient-Device Incompatibility	31	31
Fluid/Blood Leak	27	27
Material Puncture/Hole	26	26
Contamination	24	24
Off-Label Use	23	23
Patient Device Interaction Problem	22	25
Nonstandard Device	21	21
Partial Blockage	18	18
Manufacturing, Packaging or Shipping Problem	17	17
Appropriate Term/Code Not Available	17	19
Moisture or Humidity Problem	14	15
Leak/Splash	13	13
Flaked	13	13
Use of Device Problem	13	13
Defective Device	12	12
Material Deformation	11	11
Material Frayed	10	10
Migration	10	10
Device Damaged Prior to Use	9	9
Device Contamination with Chemical or Other Material	8	8
Material Perforation	7	7
Infusion or Flow Problem	6	7
Material Rupture	6	6
Inaccurate Information	5	5
Improper or Incorrect Procedure or Method	5	5
Material Fragmentation	4	4
Contamination /Decontamination Problem	4	4
Material Twisted/Bent	4	4
Device Markings/Labelling Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Mechanical Problem	4	4
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	3	3
Human-Device Interface Problem	3	3
Deformation Due to Compressive Stress	3	5
Disconnection	3	3
Missing Information	2	2
Activation Failure	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	264	271
Thrombosis/Thrombus	163	163
Hemorrhage/Bleeding	115	116
Obstruction/Occlusion	102	102
Insufficient Information	69	70
Stenosis	65	65
Bacterial Infection	42	42
Unspecified Infection	38	38
Hematoma	35	36
Pseudoaneurysm	29	30
Seroma	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	16
Ischemia	14	16
Vascular Dissection	12	12
Fever	12	12
Aneurysm	10	10
Failure of Implant	9	9
Swelling/ Edema	9	9
Wound Dehiscence	8	8
Post Operative Wound Infection	8	8
Pain	7	8
Sepsis	6	6
Failure to Anastomose	5	5
Abdominal Pain	4	8
Device Embedded In Tissue or Plaque	4	4
Ischemia Stroke	4	4
Hypersensitivity/Allergic reaction	4	4
Heart Failure/Congestive Heart Failure	4	4
Inflammation	4	4
Rupture	4	5
No Consequences Or Impact To Patient	3	3
Erosion	3	3
Extravasation	3	3
Abscess	3	3
No Patient Involvement	3	3
Purulent Discharge	3	3
Blood Loss	2	2
Syncope/Fainting	2	2
Fistula	2	2
Cellulitis	2	2
Local Reaction	2	2
Rash	2	2
Quadriplegia	2	2
Low Blood Pressure/ Hypotension	2	2
Unspecified Vascular Problem	2	2
Thromboembolism	2	2
Chest Pain	2	2
Implant Pain	2	2
Stroke/CVA	2	2
Dyspnea	2	2