TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1506	1506
Adverse Event Without Identified Device or Use Problem	613	613
Patient Device Interaction Problem	297	297
Central Regurgitation	157	157
Inadequacy of Device Shape and/or Size	118	118
Material Separation	44	44
Appropriate Term/Code Not Available	43	43
Lack of Effect	38	38
Backflow	30	30
Gradient Increase	29	29
Detachment of Device or Device Component	24	24
Device Stenosis	23	23
Fluid/Blood Leak	21	21
Perivalvular Leak	18	18
Incomplete Coaptation	16	16
Leak/Splash	14	14
Patient-Device Incompatibility	14	14
Break	13	13
No Apparent Adverse Event	12	12
Improper or Incorrect Procedure or Method	10	10
Material Split, Cut or Torn	9	9
Calcified	9	9
Obstruction of Flow	8	8
Degraded	7	7
Off-Label Use	6	6
Use of Device Problem	5	5
Material Deformation	5	5
Reflux within Device	4	4
Device Markings/Labelling Problem	4	4
Fracture	4	4
Tear, Rip or Hole in Device Packaging	4	4
Partial Blockage	4	4
Packaging Problem	4	4
Delivered as Unsterile Product	4	4
Thickening of Material	3	3
Material Protrusion/Extrusion	3	3
Structural Problem	3	3
Improper Flow or Infusion	3	3
Unsealed Device Packaging	3	3
Unintended Movement	3	3
Difficult to Open or Remove Packaging Material	3	3
Separation Problem	3	3
Material Frayed	3	3
Material Integrity Problem	2	2
Device Dislodged or Dislocated	2	2
Device Appears to Trigger Rejection	2	2
Biocompatibility	2	2
Material Perforation	1	1
Material Twisted/Bent	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1105	1105
No Information	438	438
Mitral Valve Insufficiency/ Regurgitation	397	397
Mitral Regurgitation	229	229
Non specific EKG/ECG Changes	159	159
Atrial Fibrillation	137	137
Heart Block	101	101
Mitral Valve Stenosis	99	99
Tricuspid Valve Insufficiency/ Regurgitation	77	77
Stroke/CVA	76	76
No Clinical Signs, Symptoms or Conditions	75	75
Dyspnea	59	59
Endocarditis	59	59
Hemorrhage/Bleeding	54	54
Tachycardia	48	48
Heart Failure/Congestive Heart Failure	42	42
Bradycardia	34	34
Pericardial Effusion	32	32
Cardiomyopathy	31	31
Pleural Effusion	29	29
Tricuspid Regurgitation	29	29
No Known Impact Or Consequence To Patient	26	26
Atrial Flutter	24	24
Myocardial Infarction	22	22
Unspecified Infection	21	21
Low Cardiac Output	21	21
Blood Loss	18	18
Mitral Insufficiency	17	17
Arrhythmia	16	16
Anemia	16	16
Transient Ischemic Attack	16	16
Pneumothorax	15	15
Valvular Insufficiency/ Regurgitation	14	14
Mitral Valve Prolapse	14	14
Coagulation Disorder	14	14
Congestive Heart Failure	14	14
Hematoma	13	13
Aortic Valve Insufficiency/ Regurgitation	13	13
Renal Failure	12	12
Calcium Deposits/Calcification	11	11
Hemothorax	11	11
Respiratory Failure	11	11
Cardiac Arrest	10	10
Complete Heart Block	10	10
Post Operative Wound Infection	9	9
Thrombosis/Thrombus	9	9
Thromboembolism	9	9
Chest Pain	9	9
Death	9	9
Cusp Tear	9	9