TPLC - Total Product Life Cycle

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Device	transcatheter septal occluder
Definition	Approved PMA: P000039
Product Code	MLV
Device Class	3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
27	21	14	11	3	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Fold, Unfold or Collapse	961	961
Material Deformation	699	699
Adverse Event Without Identified Device or Use Problem	471	471
Migration or Expulsion of Device	257	257
Patient Device Interaction Problem	172	172
Patient-Device Incompatibility	100	100
Migration	99	99
Off-Label Use	97	97
Biocompatibility	93	93
Improper or Incorrect Procedure or Method	69	69
Human-Device Interface Problem	40	40
Device Dislodged or Dislocated	38	38
Unintended Movement	34	34
Inadequacy of Device Shape and/or Size	27	27
Material Protrusion/Extrusion	17	17
Difficult or Delayed Positioning	17	17
Insufficient Information	16	16
Break	16	16
Activation Failure	13	13
Detachment of Device or Device Component	13	13
Fracture	12	12
Difficult to Remove	11	11
Malposition of Device	11	11
Use of Device Problem	10	10
Retraction Problem	10	10
Positioning Problem	9	9
Leak/Splash	9	9
Device Appears to Trigger Rejection	8	8
No Apparent Adverse Event	8	8
Material Separation	8	8
Premature Separation	7	7
Air/Gas in Device	7	7
Separation Problem	6	6
Entrapment of Device	6	6
Device Difficult to Setup or Prepare	6	6
Expulsion	5	5
Activation, Positioning or Separation Problem	5	5
Positioning Failure	5	5
Obstruction of Flow	5	5
Material Erosion	5	5
Device Slipped	4	4
Mechanical Problem	4	4
Contamination /Decontamination Problem	4	4
Difficult to Advance	4	4
Failure to Disconnect	3	3
Defective Component	3	3
Deformation Due to Compressive Stress	3	3
Loose or Intermittent Connection	3	3
Material Integrity Problem	3	3
Perivalvular Leak	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1498	1498
No Known Impact Or Consequence To Patient	298	298
No Consequences Or Impact To Patient	216	216
Atrial Fibrillation	163	163
Pericardial Effusion	140	140
Thrombosis/Thrombus	122	122
Arrhythmia	75	75
Stroke/CVA	71	71
Erosion	57	57
Cardiac Tamponade	53	53
Foreign Body Embolism	50	50
Insufficient Information	46	46
Hemorrhage/Bleeding	46	46
Tachycardia	43	43
Thrombus	42	42
Chest Pain	41	41
Low Blood Pressure/ Hypotension	41	41
Heart Block	39	39
Fever	35	35
Endocarditis	34	34
Embolism	32	32
Dyspnea	31	31
Obstruction/Occlusion	31	31
Transient Ischemic Attack	27	27
Atrial Flutter	26	26
Embolism/Embolus	23	23
No Code Available	22	22
Cardiac Arrest	20	20
Bradycardia	18	18
Heart Failure/Congestive Heart Failure	17	17
Cardiac Perforation	17	17
Hemolysis	16	16
Headache	16	16
Myocardial Infarction	15	15
Air Embolism	14	14
Hypersensitivity/Allergic reaction	14	14
Complete Heart Block	14	14
Perforation	14	14
Pain	13	13
Angina	13	13
Death	13	13
No Information	12	12
Tricuspid Valve Insufficiency/ Regurgitation	11	11
Renal Failure	10	10
Ventricular Fibrillation	10	10
Hematoma	9	9
Mitral Valve Insufficiency/ Regurgitation	9	9
Loss of consciousness	9	9
Fatigue	9	9
Failure of Implant	8	8