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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Fold, Unfold or Collapse	1549	1549
Adverse Event Without Identified Device or Use Problem	531	531
Migration or Expulsion of Device	319	320
Material Deformation	296	296
Patient Device Interaction Problem	249	250
Off-Label Use	121	121
Patient-Device Incompatibility	117	117
Migration	93	94
Improper or Incorrect Procedure or Method	79	79
Device Dislodged or Dislocated	39	39
Biocompatibility	38	38
Device Appears to Trigger Rejection	22	22
Material Protrusion/Extrusion	22	22
Human-Device Interface Problem	20	20
Difficult or Delayed Positioning	18	18
Break	16	16
Malposition of Device	15	15
Premature Separation	14	14
Fracture	14	14
Detachment of Device or Device Component	14	14
Positioning Failure	13	13
Difficult to Remove	13	13
Inadequacy of Device Shape and/or Size	12	12
Air/Gas in Device	12	12
Insufficient Information	11	11
Device Difficult to Setup or Prepare	11	11
Activation Failure	10	10
Material Separation	10	10
Positioning Problem	9	9
Use of Device Problem	8	8
Difficult to Advance	8	8
Separation Problem	7	7
No Apparent Adverse Event	7	7
Entrapment of Device	6	6
Device Slipped	5	5
Retraction Problem	5	5
Contamination /Decontamination Problem	4	4
Activation, Positioning or Separation Problem	4	4
Expulsion	4	4
Device Damaged by Another Device	4	4
Deformation Due to Compressive Stress	3	3
Material Twisted/Bent	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Material Integrity Problem	2	2
Material Fragmentation	2	2
Difficult to Insert	2	2
Stretched	2	2
Defective Device	2	2
Obstruction of Flow	2	2
Loose or Intermittent Connection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2233	2234
Atrial Fibrillation	194	194
Thrombosis/Thrombus	167	167
Pericardial Effusion	143	143
Stroke/CVA	99	99
Arrhythmia	81	81
Insufficient Information	71	71
Foreign Body Embolism	67	67
Hemorrhage/Bleeding	63	63
Heart Block	58	58
Cardiac Tamponade	54	54
Tachycardia	51	51
Transient Ischemic Attack	47	47
Obstruction/Occlusion	45	45
Erosion	37	37
Low Blood Pressure/ Hypotension	35	35
Endocarditis	34	34
Fever	33	33
Dyspnea	30	31
Atrial Flutter	29	29
Heart Failure/Congestive Heart Failure	28	28
Embolism/Embolus	27	27
Cardiac Arrest	24	24
Angina	24	24
Headache	21	21
Hypersensitivity/Allergic reaction	20	20
Myocardial Infarction	18	18
Air Embolism	18	18
Bradycardia	17	17
Chest Pain	17	17
Hemolysis	16	16
Tricuspid Valve Insufficiency/ Regurgitation	14	14
Ventricular Fibrillation	14	14
Pain	14	14
Renal Failure	14	14
Perforation	13	13
Fatigue	13	13
Mitral Valve Insufficiency/ Regurgitation	13	13
No Known Impact Or Consequence To Patient	13	13
Cardiac Perforation	12	12
Anemia	12	12
Movement Disorder	11	11
Pulmonary Embolism	11	11
Non specific EKG/ECG Changes	11	11
Hematoma	9	9
No Consequences Or Impact To Patient	9	9
Ischemia Stroke	9	9
Hypoxia	8	8
Failure of Implant	8	8
Unspecified Tissue Injury	7	7