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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incomplete Coaptation	3144	3175
Adverse Event Without Identified Device or Use Problem	2762	7224
Unintended Movement	2064	2064
Difficult to Open or Close	1748	1748
Difficult or Delayed Positioning	863	863
Difficult to Remove	739	739
Positioning Failure	688	688
Entrapment of Device	514	514
Migration	502	502
Off-Label Use	442	442
Device Damaged by Another Device	427	427
Improper or Incorrect Procedure or Method	421	421
Break	305	305
Physical Resistance/Sticking	283	283
Leak/Splash	274	274
Mechanical Jam	243	243
Difficult or Delayed Activation	239	239
Expulsion	225	229
Activation Failure	190	190
Material Deformation	147	147
Material Separation	138	138
Premature Activation	74	74
Material Split, Cut or Torn	74	74
Retraction Problem	74	74
Product Quality Problem	72	72
Difficult to Insert	64	64
Deformation Due to Compressive Stress	55	55
Unstable	48	48
Noise, Audible	47	47
Patient Device Interaction Problem	47	47
Air/Gas in Device	32	32
Material Protrusion/Extrusion	31	31
Crack	25	25
Difficult to Advance	25	25
No Apparent Adverse Event	24	24
Material Frayed	20	20
Stretched	20	20
Failure to Advance	16	16
Device Difficult to Setup or Prepare	12	12
Difficult to Flush	12	12
Malposition of Device	11	11
Tear, Rip or Hole in Device Packaging	11	11
Detachment of Device or Device Component	10	10
Separation Failure	8	8
Activation, Positioning or Separation Problem	7	7
Loose or Intermittent Connection	7	7
Activation Problem	6	6
Device Contamination with Chemical or Other Material	5	5
Device-Device Incompatibility	4	4
Device Dislodged or Dislocated	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4800	5364
Mitral Valve Insufficiency/ Regurgitation	2437	3340
Unspecified Tissue Injury	1864	1895
No Consequences Or Impact To Patient	1003	1003
Mitral Regurgitation	778	778
Tissue Damage	503	503
Heart Failure/Congestive Heart Failure	464	1172
Dyspnea	463	463
Foreign Body In Patient	390	394
Mitral Valve Stenosis	315	315
Death	260	260
Stroke/CVA	253	268
Pericardial Effusion	233	233
Hemorrhage/Bleeding	221	403
Tricuspid Valve Insufficiency/ Regurgitation	221	221
Insufficient Information	210	2049
Heart Failure	210	210
Low Blood Pressure/ Hypotension	209	209
Embolism/Embolus	150	150
No Patient Involvement	142	142
Renal Failure	133	172
Thrombosis/Thrombus	122	122
Air Embolism	121	121
Atrial Fibrillation	106	169
Myocardial Infarction	104	134
Cardiac Arrest	99	157
Endocarditis	95	104
Cardiac Tamponade	87	87
Cardiogenic Shock	83	83
Perforation	76	76
Fatigue	74	74
Tachycardia	67	67
Arrhythmia	62	62
High Blood Pressure/ Hypertension	55	55
Embolism	53	53
Sepsis	52	52
Pulmonary Edema	51	51
Tricuspid Regurgitation	51	51
Thrombosis	44	44
Unspecified Infection	44	60
Respiratory Failure	43	43
Swelling/ Edema	40	40
Cusp Tear	36	36
Fever	35	35
Transient Ischemic Attack	33	40
Non specific EKG/ECG Changes	31	31
Hypoxia	29	29
Shock	28	28
Angina	27	27
Hematoma	24	40