TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	186	186
Insufficient Information	136	136
Peeled/Delaminated	113	113
Obstruction of Flow	95	95
Material Split, Cut or Torn	72	72
Patient-Device Incompatibility	59	59
Material Integrity Problem	53	53
Complete Blockage	51	51
Material Puncture/Hole	49	49
Manufacturing, Packaging or Shipping Problem	46	46
Microbial Contamination of Device	44	44
Product Quality Problem	38	38
Contamination	38	38
Material Separation	36	36
Leak/Splash	33	33
Appropriate Term/Code Not Available	26	26
Partial Blockage	25	25
Nonstandard Device	25	25
Patient Device Interaction Problem	25	25
Off-Label Use	23	23
Use of Device Problem	20	20
Flaked	19	19
Occlusion Within Device	19	19
Fluid/Blood Leak	17	17
Material Perforation	17	17
Device Stenosis	16	16
Mechanical Problem	15	15
Material Deformation	14	14
Device Operates Differently Than Expected	13	13
Infusion or Flow Problem	9	9
Device Damaged Prior to Use	9	9
Detachment of Device or Device Component	9	9
Migration	9	9
Defective Device	9	9
Shipping Damage or Problem	8	8
Material Frayed	7	7
Device Handling Problem	6	6
Material Rupture	6	6
No Apparent Adverse Event	6	6
Torn Material	6	6
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	5	5
Device Contamination with Chemical or Other Material	5	5
Inaccurate Information	5	5
Contamination /Decontamination Problem	4	4
Unraveled Material	4	4
Device Markings/Labelling Problem	4	4
Material Twisted/Bent	4	4
Break	4	4
Loosening of Implant Not Related to Bone-Ingrowth	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	216	216
Unspecified Infection	140	140
Thrombosis/Thrombus	104	104
Hemorrhage/Bleeding	94	94
No Consequences Or Impact To Patient	68	68
Thrombosis	64	64
Stenosis	63	63
Obstruction/Occlusion	61	61
Blood Loss	54	54
Insufficient Information	48	48
Bacterial Infection	46	46
Occlusion	46	46
Hematoma	46	46
Death	43	43
Seroma	43	43
Pseudoaneurysm	41	41
No Known Impact Or Consequence To Patient	39	39
No Patient Involvement	33	33
No Information	23	23
No Code Available	22	22
Ischemia	20	20
Thrombus	19	19
Aneurysm	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Pain	15	15
Vascular Dissection	14	14
Post Operative Wound Infection	11	11
Failure of Implant	11	11
Inflammation	10	10
Wound Dehiscence	8	8
Sepsis	8	8
Fever	8	8
Renal Failure	7	7
Rupture	6	6
Failure to Anastomose	6	6
Swelling	6	6
Foreign Body In Patient	5	5
Exsanguination	5	5
Hypersensitivity/Allergic reaction	5	5
Heart Failure/Congestive Heart Failure	4	4
Perforation of Vessels	4	4
Swelling/ Edema	4	4
Embolism	4	4
Ischemia Stroke	4	4
Fistula	4	4
Cardiac Arrest	4	4
Abdominal Pain	4	4
Edema	4	4
Purulent Discharge	4	4
Low Blood Pressure/ Hypotension	3	3