TPLC - Total Product Life Cycle

• Device: occluder, patent ductus, arteriosus
• Product Code: MAE
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
6	6	1	1	1	0

MDR Year	MDR Reports	MDR Events
2019	53	53
2020	109	109
2021	76	76
2022	80	80
2023	128	128
2024	33	33

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration or Expulsion of Device	191	191
Difficult to Fold, Unfold or Collapse	71	71
Improper or Incorrect Procedure or Method	52	52
Adverse Event Without Identified Device or Use Problem	49	49
Material Deformation	38	38
Off-Label Use	36	36
Patient Device Interaction Problem	30	30
Migration	20	20
Obstruction of Flow	18	18
Unintended Movement	18	18
Malposition of Device	14	14
Human-Device Interface Problem	11	11
Use of Device Problem	10	10
Patient-Device Incompatibility	10	10
Biocompatibility	9	9
Inadequacy of Device Shape and/or Size	8	8
Gradient Increase	6	6
Difficult to Insert	5	5
Failure to Advance	4	4
Device Dislodged or Dislocated	4	4
Premature Separation	4	4
Positioning Problem	3	3
Activation, Positioning or Separation Problem	3	3
No Apparent Adverse Event	3	3
Insufficient Information	2	2
Detachment of Device or Device Component	2	2
Difficult to Advance	2	2
Material Separation	2	2
Break	2	2
Difficult or Delayed Positioning	2	2
Entrapment of Device	1	1
Unintended Ejection	1	1
Inaccurate Flow Rate	1	1
Leak/Splash	1	1
Fracture	1	1
Difficult to Remove	1	1
Retraction Problem	1	1
Premature Activation	1	1
Expulsion	1	1
Connection Problem	1	1
Activation Failure	1	1
Material Protrusion/Extrusion	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	185	185
Obstruction/Occlusion	63	63
No Known Impact Or Consequence To Patient	51	51
Embolism	42	42
No Consequences Or Impact To Patient	24	24
Insufficient Information	21	21
Foreign Body Embolism	18	18
Arrhythmia	13	13
Hemorrhage/Bleeding	13	13
Thrombosis/Thrombus	11	11
Tricuspid Valve Insufficiency/ Regurgitation	11	11
Sepsis	10	10
Renal Failure	9	9
Hypoxia	9	9
Cardiac Tamponade	8	8
Stenosis	8	8
Heart Failure/Congestive Heart Failure	8	8
Pericardial Effusion	8	8
High Blood Pressure/ Hypertension	7	7
Low Blood Pressure/ Hypotension	7	7
Death	7	7
Tachycardia	6	6
Heart Block	6	6
Respiratory Insufficiency	6	6
Complete Heart Block	5	5
Dyspnea	5	5
Hematoma	5	5
Hemolysis	5	5
Bradycardia	4	4
Cardiac Arrest	4	4
Foreign Body In Patient	4	4
Cardiac Perforation	3	3
Aortic Valve Stenosis	3	3
Pulmonary Embolism	3	3
Failure of Implant	3	3
Unspecified Infection	3	3
Inflammation	3	3
Myocardial Infarction	3	3
Perforation	3	3
No Information	3	3
Embolism/Embolus	3	3
Valvular Insufficiency/ Regurgitation	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Necrosis	2	2
Endocarditis	2	2
Congestive Heart Failure	2	2
Pseudoaneurysm	2	2
Hemolytic Anemia	2	2
Thrombosis	2	2
Pulmonary Valve Stenosis	2	2
Pneumonia	2	2
Pneumothorax	1	1
Pulmonary Dysfunction	1	1
Pulmonary Edema	1	1
Rupture	1	1
Tissue Damage	1	1
Transient Ischemic Attack	1	1
Tricuspid Insufficiency	1	1
Tricuspid Regurgitation	1	1
Vasoconstriction	1	1
Perforation of Esophagus	1	1
Respiratory Tract Infection	1	1
Regurgitation	1	1
Prolapse	1	1
Aortic Dissection	1	1
Diminished Pulse Pressure	1	1
Hematuria	1	1
Loss Of Pulse	1	1
Patient Problem/Medical Problem	1	1
Alteration In Body Temperature	1	1
Embolus	1	1
Stroke/CVA	1	1
Dysphagia/ Odynophagia	1	1
Adult Respiratory Distress Syndrome	1	1
Air Embolism	1	1
Anemia	1	1
Vessel Or Plaque, Device Embedded In	1	1
Atrial Flutter	1	1
Erosion	1	1
Fatigue	1	1
Fistula	1	1
Hemothorax	1	1
Occlusion	1	1
Pleural Effusion	1	1
Ischemia	1	1
Renal Impairment	1	1
Unspecified Tissue Injury	1	1
Pulmonary Hypertension	1	1
Cardiovascular Insufficiency	1	1
Convulsion/Seizure	1	1
Movement Disorder	1	1
Vascular Dissection	1	1
Device Embedded In Tissue or Plaque	1	1