TPLC - Total Product Life Cycle

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Device	heart-valve, non-allograft tissue
Product Code	LWR
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
15	17	25	18	31	27	14	27	54	64	50	32	18	37	26	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	4884	4884
Adverse Event Without Identified Device or Use Problem	1644	1644
Gradient Increase	1221	1221
Perivalvular Leak	1012	1012
Calcified	811	811
Material Split, Cut or Torn	802	802
Degraded	702	702
Obstruction of Flow	523	523
Incomplete Coaptation	521	521
Patient-Device Incompatibility	495	495
Central Regurgitation	432	432
Inadequacy of Device Shape and/or Size	407	407
Patient Device Interaction Problem	390	390
Backflow	378	378
Device Stenosis	356	356
Leak/Splash	339	339
Fluid/Blood Leak	305	305
Torn Material	280	280
Appropriate Term/Code Not Available	241	241
Material Deformation	198	198
Biocompatibility	151	151
Device Operates Differently Than Expected	138	138
Difficult to Open or Close	123	123
Material Too Rigid or Stiff	109	109
Detachment of Device or Device Component	91	91
Material Separation	83	83
Occlusion Within Device	82	82
Structural Problem	81	81
Device Dislodged or Dislocated	77	77
Microbial Contamination of Device	71	71
Malposition of Device	66	66
Off-Label Use	65	65
Collapse	63	63
Material Rupture	54	54
Material Perforation	49	49
Material Puncture/Hole	38	38
Difficult to Fold, Unfold or Collapse	37	37
Break	37	37
No Apparent Adverse Event	33	33
Migration	31	31
Material Integrity Problem	30	30
Material Distortion	28	28
Migration or Expulsion of Device	27	27
Positioning Failure	27	27
Partial Blockage	26	26
Therapeutic or Diagnostic Output Failure	26	26
Hole In Material	24	24
Use of Device Problem	24	24
Improper or Incorrect Procedure or Method	21	21
Infusion or Flow Problem	19	19

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	2150	2150
Aortic Valve Stenosis	1842	1842
No Information	1692	1695
Aortic Valve Insufficiency/ Regurgitation	1316	1316
Aortic Regurgitation	1193	1193
Aortic Insufficiency	1087	1087
Endocarditis	956	956
Dyspnea	871	871
Death	610	610
Heart Failure/Congestive Heart Failure	560	560
Calcium Deposits/Calcification	529	529
No Known Impact Or Consequence To Patient	511	511
No Clinical Signs, Symptoms or Conditions	395	395
Complete Heart Block	369	369
Mitral Regurgitation	312	312
Stroke/CVA	290	290
Hemorrhage/Bleeding	288	288
Corneal Pannus	260	260
Stenosis	238	238
Cusp Tear	222	222
Mitral Valve Insufficiency/ Regurgitation	213	213
Atrial Fibrillation	213	213
No Code Available	208	208
Pulmonary Valve Stenosis	204	205
Mitral Valve Stenosis	197	198
Heart Failure	181	181
Arrhythmia	178	179
Non specific EKG/ECG Changes	172	172
Thrombosis/Thrombus	168	168
Thrombus	168	169
Heart Block	161	161
Fatigue	148	148
Unspecified Infection	134	134
Renal Failure	128	129
Myocardial Infarction	116	116
Chest Pain	112	112
Congestive Heart Failure	112	112
Regurgitation	104	104
Pseudoaneurysm	102	102
Pulmonary Regurgitation	98	98
Thrombosis	90	90
Blood Loss	88	89
Valvular Insufficiency/ Regurgitation	85	85
Cardiac Arrest	85	85
Obstruction/Occlusion	84	84
Insufficiency, Valvular	84	84
Mitral Insufficiency	78	79
Pulmonary Edema	77	77
No Consequences Or Impact To Patient	73	73
Regurgitation, Valvular	71	71

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Cardiovascular Surgery-the Heart Valve Division	II	Feb-03-2014
2	Sorin Group Italia S.r.l.	II	Sep-18-2020
3	Sorin Group USA, Inc.	II	Dec-07-2016