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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	121	121
Peeled/Delaminated	91	91
Obstruction of Flow	69	69
Insufficient Information	56	56
Material Split, Cut or Torn	51	51
Patient-Device Incompatibility	47	47
Complete Blockage	42	42
Contamination	37	37
Material Integrity Problem	36	36
Microbial Contamination of Device	36	36
Material Puncture/Hole	34	34
Material Separation	30	30
Product Quality Problem	27	27
Nonstandard Device	24	24
Partial Blockage	20	20
Off-Label Use	19	19
Patient Device Interaction Problem	19	19
Flaked	17	17
Device Stenosis	16	16
Use of Device Problem	16	16
Leak/Splash	14	14
Fluid/Blood Leak	14	14
Material Deformation	11	11
Manufacturing, Packaging or Shipping Problem	11	11
Appropriate Term/Code Not Available	11	11
Material Perforation	10	10
Defective Device	10	10
Mechanical Problem	9	9
Device Damaged Prior to Use	9	9
Migration	9	9
Infusion or Flow Problem	8	8
Material Frayed	7	7
Material Rupture	6	6
Material Fragmentation	5	5
Inaccurate Information	5	5
Improper or Incorrect Procedure or Method	5	5
Contamination /Decontamination Problem	4	4
Shipping Damage or Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Detachment of Device or Device Component	4	4
Material Twisted/Bent	4	4
Device Markings/Labelling Problem	4	4
No Apparent Adverse Event	3	3
Human-Device Interface Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Packaging Problem	3	3
Deformation Due to Compressive Stress	3	3
Compatibility Problem	3	3
Missing Information	2	2
Fracture	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	219	219
Thrombosis/Thrombus	105	105
Hemorrhage/Bleeding	90	90
Obstruction/Occlusion	61	61
Unspecified Infection	54	54
Insufficient Information	48	48
Bacterial Infection	43	43
Hematoma	33	33
Stenosis	32	32
Pseudoaneurysm	28	28
Seroma	23	23
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
Ischemia	14	14
Vascular Dissection	13	13
No Code Available	13	13
No Patient Involvement	12	12
Aneurysm	11	11
Pain	9	9
Post Operative Wound Infection	9	9
Wound Dehiscence	8	8
Thrombus	8	8
Blood Loss	8	8
Failure of Implant	7	7
Inflammation	6	6
Death	6	6
Sepsis	5	5
No Information	5	5
Failure to Anastomose	5	5
Rupture	5	5
Swelling/ Edema	4	4
Heart Failure/Congestive Heart Failure	4	4
Ischemia Stroke	4	4
Abdominal Pain	4	4
Fever	4	4
Perforation of Vessels	3	3
Erosion	3	3
Renal Failure	3	3
Fistula	3	3
Foreign Body In Patient	3	3
Purulent Discharge	3	3
Hypersensitivity/Allergic reaction	3	3
No Known Impact Or Consequence To Patient	2	2
Rash	2	2
High Blood Pressure/ Hypertension	2	2
Syncope/Fainting	2	2
Quadriplegia	2	2
Low Blood Pressure/ Hypotension	2	2