TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORCYM S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
1. K251688 Carpentier-Edwards Physio Annuloplasty Ring (4450)
2. K251982 Edwards MC3 Tricuspid annuloplasty ring (4900)
GENESEE BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	1037	1039
Adverse Event Without Identified Device or Use Problem	490	492
Patient Device Interaction Problem	338	338
Central Regurgitation	193	193
Inadequacy of Device Shape and/or Size	64	64
Lack of Effect	45	45
Material Separation	34	34
Appropriate Term/Code Not Available	33	33
Device Stenosis	29	29
Perivalvular Leak	18	18
Gradient Increase	17	18
Break	17	17
Incomplete Coaptation	14	14
Leak/Splash	13	13
Fluid/Blood Leak	12	13
Backflow	11	11
Detachment of Device or Device Component	10	10
Calcified	7	7
Structural Problem	7	7
Material Split, Cut or Torn	6	6
Patient-Device Incompatibility	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	1166	1169
Mitral Valve Insufficiency/ Regurgitation	421	421
Non specific EKG/ECG Changes	152	152
Atrial Fibrillation	122	122
Heart Block	114	114
No Clinical Signs, Symptoms or Conditions	78	78
Tricuspid Valve Insufficiency/ Regurgitation	77	77
Mitral Valve Stenosis	64	65
Stroke/CVA	54	54
Hemorrhage/Bleeding	53	53
Tachycardia	52	52
Dyspnea	48	48
Heart Failure/Congestive Heart Failure	43	43
Endocarditis	40	40
Bradycardia	33	33
Pericardial Effusion	31	31
Cardiomyopathy	31	31
Atrial Flutter	27	27
Pleural Effusion	24	24
Valvular Insufficiency/ Regurgitation	18	18
Pneumothorax	16	16
Anemia	15	15
Aortic Valve Insufficiency/ Regurgitation	15	16
Arrhythmia	14	14
Unspecified Infection	14	14
Hematoma	13	13
Myocardial Infarction	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
Calcium Deposits/Calcification	9	9
Transient Ischemic Attack	9	9
Cusp Tear	9	10
Hemothorax	8	8
Cardiac Arrest	8	8
Post Operative Wound Infection	7	7
Swelling/ Edema	7	7
Prolapse	6	6
Tricuspid Valve Stenosis	6	6
Foreign Body Reaction	6	6
Thromboembolism	6	6
Pseudoaneurysm	6	6
Fatigue	6	6
Syncope/Fainting	5	5
Cardiac Tamponade	5	5
Pulmonary Edema	5	5
Respiratory Failure	5	5