TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1032	1034
Adverse Event Without Identified Device or Use Problem	485	487
Patient Device Interaction Problem	330	330
Central Regurgitation	182	182
Inadequacy of Device Shape and/or Size	63	63
Lack of Effect	44	44
Material Separation	34	34
Appropriate Term/Code Not Available	32	32
Device Stenosis	27	27
Perivalvular Leak	18	18
Gradient Increase	17	18
Break	15	15
Leak/Splash	13	13
Incomplete Coaptation	12	12
Fluid/Blood Leak	11	12
Backflow	11	11
Detachment of Device or Device Component	10	10
Calcified	7	7
Material Split, Cut or Torn	6	6
Patient-Device Incompatibility	6	6
Structural Problem	6	6
Improper or Incorrect Procedure or Method	5	5
Thickening of Material	5	5
Degraded	5	5
Packaging Problem	4	4
Material Deformation	4	4
Fracture	3	3
Material Protrusion/Extrusion	3	3
Tear, Rip or Hole in Device Packaging	3	3
Reflux within Device	3	3
Obstruction of Flow	2	2
Delivered as Unsterile Product	2	2
Use of Device Problem	2	2
Partial Blockage	2	2
Material Integrity Problem	2	2
Unsealed Device Packaging	2	2
No Apparent Adverse Event	2	2
Device Markings/Labelling Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Material Frayed	2	2
Particulates	1	1
Contamination /Decontamination Problem	1	1
Difficult to Remove	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Labelling, Instructions for Use or Training Problem	1	1
Output Problem	1	1
Off-Label Use	1	1
Device Dislodged or Dislocated	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	1152	1155
Mitral Valve Insufficiency/ Regurgitation	409	409
Non specific EKG/ECG Changes	151	151
Atrial Fibrillation	120	120
Heart Block	110	110
No Clinical Signs, Symptoms or Conditions	78	78
Tricuspid Valve Insufficiency/ Regurgitation	77	77
Mitral Valve Stenosis	62	63
Stroke/CVA	54	54
Hemorrhage/Bleeding	52	52
Tachycardia	51	51
Dyspnea	47	47
Heart Failure/Congestive Heart Failure	43	43
Endocarditis	39	39
Bradycardia	33	33
Cardiomyopathy	31	31
Pericardial Effusion	30	30
Atrial Flutter	26	26
Pleural Effusion	24	24
Valvular Insufficiency/ Regurgitation	17	17
Pneumothorax	16	16
Aortic Valve Insufficiency/ Regurgitation	15	16
Anemia	15	15
Unspecified Infection	14	14
Arrhythmia	14	14
Myocardial Infarction	12	12
Hematoma	12	12
Coagulation Disorder	11	11
Renal Failure	10	10
Low Cardiac Output	10	10
Chest Pain	9	9
Thrombosis/Thrombus	9	9
Ventricular Fibrillation	9	9
Transient Ischemic Attack	9	9
Cusp Tear	9	10
Hemothorax	8	8
Cardiac Arrest	8	8
Calcium Deposits/Calcification	8	8
Post Operative Wound Infection	7	7
Prolapse	6	6
Swelling/ Edema	6	6
Thromboembolism	6	6
Pseudoaneurysm	6	6
Foreign Body Reaction	6	6
Fatigue	6	6
Tricuspid Valve Stenosis	6	6
Respiratory Failure	5	5
Syncope/Fainting	5	5
Low Blood Pressure/ Hypotension	5	5
Cardiogenic Shock	5	5