TPLC - Total Product Life Cycle

show TPLC since

Device	mitral valve repair devices
Definition	To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Product Code	NKM
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
1	5	12	20	15	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	3685	3719
Adverse Event Without Identified Device or Use Problem	3172	7635
Unintended Movement	2451	2453
Difficult to Open or Close	2145	2145
Difficult or Delayed Positioning	1018	1019
Difficult to Remove	834	834
Positioning Failure	821	822
Migration	620	620
Entrapment of Device	613	613
Off-Label Use	520	609
Device Damaged by Another Device	516	516
Improper or Incorrect Procedure or Method	489	489
Break	365	365
Physical Resistance/Sticking	329	329
Leak/Splash	309	309
Activation Failure	304	304
Mechanical Jam	273	273
Difficult or Delayed Activation	272	272
Expulsion	255	259
Material Deformation	167	167
Material Separation	151	151
Difficult to Flush	149	149
Difficult to Insert	98	98
Material Split, Cut or Torn	91	92
Premature Activation	87	87
Retraction Problem	85	85
Patient Device Interaction Problem	84	84
Product Quality Problem	77	77
Deformation Due to Compressive Stress	70	70
Air/Gas in Device	68	68
Noise, Audible	52	52
Unstable	52	52
No Apparent Adverse Event	33	33
Material Protrusion/Extrusion	33	33
Difficult to Advance	29	29
Crack	28	28
Material Frayed	22	22
Malposition of Device	21	21
Stretched	20	20
Failure to Advance	18	18
Device Difficult to Setup or Prepare	12	12
Tear, Rip or Hole in Device Packaging	12	12
Separation Failure	11	12
Activation Problem	10	10
Detachment of Device or Device Component	10	10
Loose or Intermittent Connection	7	7
Activation, Positioning or Separation Problem	7	7
Device-Device Incompatibility	7	7
Insufficient Information	6	8
Device Contamination with Chemical or Other Material	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6156	6725
Mitral Valve Insufficiency/ Regurgitation	3004	3908
Unspecified Tissue Injury	2309	2340
No Consequences Or Impact To Patient	1003	1003
Mitral Regurgitation	778	778
Dyspnea	580	580
Heart Failure/Congestive Heart Failure	570	1294
Tissue Damage	503	503
Foreign Body In Patient	434	438
Mitral Valve Stenosis	368	368
Tricuspid Valve Insufficiency/ Regurgitation	310	354
Stroke/CVA	295	310
Pericardial Effusion	270	271
Death	260	260
Hemorrhage/Bleeding	251	440
Low Blood Pressure/ Hypotension	244	244
Insufficient Information	219	2058
Heart Failure	210	210
Air Embolism	177	177
Embolism/Embolus	177	177
Renal Failure	153	194
No Patient Involvement	142	142
Thrombosis/Thrombus	133	134
Myocardial Infarction	125	156
Cardiac Arrest	116	181
Atrial Fibrillation	115	188
Cardiac Tamponade	106	106
Endocarditis	101	110
Cardiogenic Shock	98	98
Fatigue	90	90
Perforation	90	90
Arrhythmia	78	78
Tachycardia	76	76
High Blood Pressure/ Hypertension	62	62
Cusp Tear	58	58
Pulmonary Edema	56	56
Sepsis	53	53
Embolism	53	53
Tricuspid Regurgitation	51	51
Unspecified Infection	51	67
Swelling/ Edema	46	46
Respiratory Failure	45	45
Thrombosis	44	44
Cardiac Perforation	38	38
Fever	37	37
Transient Ischemic Attack	36	43
Non specific EKG/ECG Changes	36	36
Hypoxia	33	33
Angina	33	33
Shock	29	29