TPLC - Total Product Life Cycle

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Device	graft, vascular, synthetic/biologic composite
Regulation Description	Vascular graft prosthesis.
Product Code	MAL
Regulation Number	870.3450
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Product Quality Problem	24	24
Adverse Event Without Identified Device or Use Problem	20	20
Off-Label Use	19	19
Nonstandard Device	16	16
Material Frayed	11	11
Material Puncture/Hole	10	10
Insufficient Device Problem Information	8	8
Device Damaged Prior to Use	7	7
Improper or Incorrect Procedure or Method	6	6
Patient Device Interaction Problem	5	5
Device Damaged Prior to Receipt by User	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Material Integrity Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Inaccurate Information	4	4
Use of Device Problem	3	3
No Apparent Adverse Event	3	3
Flaked	2	2
Device Contaminated at the User Facility	2	2
Unsealed Device Packaging	1	1
Contamination /Decontamination Problem	1	1
Fluid/Blood Leak	1	1
Material Disintegration	1	1
Device Handling Problem	1	1
Difficult or Delayed Separation	1	1
Material Rupture	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	59	59
Hemorrhage/Blood Loss/Bleeding	36	36
Bacterial Infection	10	10
No Patient Involvement	9	9
Insufficient Information	9	10
No Consequences Or Impact To Patient	7	7
Pseudoaneurysm	4	4
Fungal Infection	4	4
Hypersensitivity/Allergic reaction	3	3
Thrombosis/Thrombus	2	2
Ventricular Fibrillation	2	2
Stenosis	2	2
Paraplegia	2	2
Adhesion(s)	2	2
High White Blood Cell Count	1	1
Failure of Implant	1	1
Exsanguination	1	1