TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
21	14	11	3	16	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Fold, Unfold or Collapse	1110	1110
Material Deformation	485	485
Adverse Event Without Identified Device or Use Problem	483	483
Migration or Expulsion of Device	280	280
Patient Device Interaction Problem	192	192
Off-Label Use	108	108
Migration	93	93
Patient-Device Incompatibility	85	85
Biocompatibility	83	83
Improper or Incorrect Procedure or Method	76	76
Human-Device Interface Problem	40	40
Device Dislodged or Dislocated	40	40
Inadequacy of Device Shape and/or Size	20	20
Material Protrusion/Extrusion	17	17
Break	15	15
Difficult or Delayed Positioning	15	15
Device Appears to Trigger Rejection	13	13
Detachment of Device or Device Component	13	13
Activation Failure	12	12
Premature Separation	11	11
Fracture	11	11
Malposition of Device	11	11
Insufficient Information	11	11
Difficult to Remove	11	11
Device Difficult to Setup or Prepare	9	9
Air/Gas in Device	9	9
No Apparent Adverse Event	8	8
Material Separation	8	8
Use of Device Problem	8	8
Retraction Problem	7	7
Positioning Failure	7	7
Separation Problem	6	6
Leak/Splash	5	5
Positioning Problem	5	5
Entrapment of Device	5	5
Contamination /Decontamination Problem	4	4
Device Slipped	4	4
Activation, Positioning or Separation Problem	4	4
Material Twisted/Bent	4	4
Difficult to Advance	4	4
Deformation Due to Compressive Stress	3	3
Loose or Intermittent Connection	3	3
Obstruction of Flow	3	3
Mechanical Problem	3	3
Product Quality Problem	3	3
Device Damaged by Another Device	3	3
Unintended Movement	3	3
Difficult to Open or Close	2	2
Expulsion	2	2
Poor Visibility	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1694	1694
Atrial Fibrillation	179	179
No Consequences Or Impact To Patient	154	154
Thrombosis/Thrombus	134	134
Pericardial Effusion	125	125
No Known Impact Or Consequence To Patient	95	95
Stroke/CVA	85	85
Arrhythmia	79	79
Insufficient Information	61	61
Foreign Body Embolism	56	56
Hemorrhage/Bleeding	55	55
Cardiac Tamponade	48	48
Heart Block	46	46
Tachycardia	46	46
Transient Ischemic Attack	38	38
Erosion	35	35
Endocarditis	34	34
Obstruction/Occlusion	34	34
Fever	32	32
Low Blood Pressure/ Hypotension	30	30
Atrial Flutter	26	26
Dyspnea	26	26
Thrombus	24	24
Embolism	24	24
Cardiac Arrest	23	23
Embolism/Embolus	23	23
Chest Pain	22	22
Myocardial Infarction	20	20
Heart Failure/Congestive Heart Failure	18	18
Bradycardia	18	18
Air Embolism	16	16
Angina	15	15
Hypersensitivity/Allergic reaction	14	14
Headache	14	14
Hemolysis	14	14
Pain	12	12
Perforation	12	12
Tricuspid Valve Insufficiency/ Regurgitation	11	11
Complete Heart Block	11	11
No Code Available	11	11
Cardiac Perforation	11	11
Pulmonary Embolism	10	10
Renal Failure	10	10
Ventricular Fibrillation	10	10
Mitral Valve Insufficiency/ Regurgitation	9	9
Hematoma	8	8
Death	8	8
Fatigue	8	8
Non specific EKG/ECG Changes	7	7
Ischemia	6	6