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)
2021	2022	2023	2024	2025	2026
14	11	3	16	8	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Fold, Unfold or Collapse	1771	1771
Adverse Event Without Identified Device or Use Problem	600	600
Migration or Expulsion of Device	362	363
Patient Device Interaction Problem	313	314
Material Deformation	294	294
Patient-Device Incompatibility	146	146
Off-Label Use	144	144
Migration	99	100
Improper or Incorrect Procedure or Method	84	84
Device Dislodged or Dislocated	41	41
Biocompatibility	38	38
Device Appears to Trigger Rejection	27	27
Difficult or Delayed Positioning	27	27
Material Protrusion/Extrusion	23	23
Human-Device Interface Problem	20	20
Break	17	17
Fracture	17	17
Malposition of Device	16	16
Detachment of Device or Device Component	16	16
Premature Separation	16	16
Air/Gas in Device	15	15
Difficult to Remove	14	14
Positioning Failure	14	14
Inadequacy of Device Shape and/or Size	12	12
Device Difficult to Setup or Prepare	11	11
Insufficient Device Problem Information	11	11
Material Separation	10	10
Difficult to Advance	10	10
Positioning Problem	10	10
No Apparent Adverse Event	8	8
Expulsion	7	7
Separation Problem	7	7
Activation Failure	6	6
Entrapment of Device	6	6
Use of Device Problem	6	6
Device Slipped	6	6
Retraction Problem	5	5
Device Damaged by Another Device	4	4
Product Quality Problem	4	4
Contamination /Decontamination Problem	4	4
Difficult to Insert	3	3
Material Twisted/Bent	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Deformation Due to Compressive Stress	2	2
Stretched	2	2
Material Integrity Problem	2	2
Material Fragmentation	2	2
Poor Visibility	2	2
Loose or Intermittent Connection	2	2
Obstruction of Flow	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2520	2521
Atrial Fibrillation	222	222
Thrombosis/Thrombus	186	186
Pericardial Effusion	181	181
Stroke/CVA	110	110
Arrhythmia	106	106
Insufficient Information	84	84
Foreign Body Embolism	77	77
Cardiac Tamponade	74	74
Hemorrhage/Blood Loss/Bleeding	72	72
Heart Block	69	69
Tachycardia	65	65
Transient Ischemic Attack	54	54
Obstruction/Occlusion	46	46
Low Blood Pressure/ Hypotension	45	45
Heart Failure/Congestive Heart Failure	39	39
Erosion	39	39
Endocarditis	38	38
Fever	35	35
Atrial Flutter	34	34
Dyspnea	31	32
Angina	31	31
Cardiac Arrest	30	30
Embolism/Embolus	30	30
Headache	29	29
Bradycardia	23	23
Myocardial Infarction	21	21
Shock	21	21
Air Embolism	21	21
Hypersensitivity/Allergic reaction	21	21
Tricuspid Valve Insufficiency/ Regurgitation	19	19
Chest Pain	18	18
Hemolysis	18	18
Perforation	18	18
Renal Failure	17	17
Pulmonary Embolism	16	16
Pain	16	16
Fatigue	16	16
Hematoma	14	14
Movement Disorder	14	14
Ventricular Fibrillation	14	14
Anemia	14	14
Non specific EKG/ECG Changes	14	14
Mitral Valve Insufficiency/ Regurgitation	13	13
Sepsis	13	13
No Known Impact Or Consequence To Patient	13	13
Cardiac Perforation	12	12
Hypoxia	11	11
Vascular Dissection	10	10
Pneumonia	10	10