TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1031	1033
Adverse Event Without Identified Device or Use Problem	473	475
Patient Device Interaction Problem	323	323
Central Regurgitation	174	174
Inadequacy of Device Shape and/or Size	63	63
Lack of Effect	44	44
Material Separation	33	33
Appropriate Term/Code Not Available	32	32
Device Stenosis	25	25
Gradient Increase	17	18
Perivalvular Leak	17	17
Break	14	14
Leak/Splash	13	13
Fluid/Blood Leak	11	12
Backflow	11	11
Incomplete Coaptation	10	10
Detachment of Device or Device Component	10	10
Calcified	7	7
Material Split, Cut or Torn	6	6
Patient-Device Incompatibility	6	6
Improper or Incorrect Procedure or Method	5	5
Degraded	5	5
Structural Problem	5	5
Packaging Problem	4	4
Material Deformation	4	4
Thickening of Material	3	3
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	1140	1143
Mitral Valve Insufficiency/ Regurgitation	402	402
Non specific EKG/ECG Changes	149	149
Atrial Fibrillation	115	115
Heart Block	108	108
No Clinical Signs, Symptoms or Conditions	78	78
Tricuspid Valve Insufficiency/ Regurgitation	75	75
Mitral Valve Stenosis	61	62
Stroke/CVA	53	53
Hemorrhage/Bleeding	52	52
Tachycardia	49	49
Dyspnea	47	47
Heart Failure/Congestive Heart Failure	42	42
Endocarditis	39	39
Bradycardia	33	33
Cardiomyopathy	31	31
Pericardial Effusion	30	30
Pleural Effusion	24	24
Atrial Flutter	24	24
Pneumothorax	16	16
Valvular Insufficiency/ Regurgitation	16	16
Anemia	15	15
Arrhythmia	14	14
Unspecified Infection	14	14
Aortic Valve Insufficiency/ Regurgitation	14	15
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
Post Operative Wound Infection	7	7
Calcium Deposits/Calcification	6	6
Swelling/ Edema	6	6
Pseudoaneurysm	6	6
Thromboembolism	6	6
Tricuspid Valve Stenosis	6	6
Foreign Body Reaction	6	6
Fatigue	6	6
Respiratory Failure	5	5
Low Blood Pressure/ Hypotension	5	5
Cardiac Tamponade	5	5
Syncope/Fainting	5	5
Cardiogenic Shock	5	5