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	40	40

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration or Expulsion of Device	194	194
Difficult to Fold, Unfold or Collapse	73	73
Improper or Incorrect Procedure or Method	52	52
Adverse Event Without Identified Device or Use Problem	51	51
Material Deformation	38	38
Off-Label Use	36	36
Patient Device Interaction Problem	31	31
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	190	190
Obstruction/Occlusion	64	64
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
Renal Failure	10	10
Sepsis	10	10
Hypoxia	9	9
Heart Failure/Congestive Heart Failure	9	9
Pericardial Effusion	8	8
Cardiac Tamponade	8	8
Stenosis	8	8
High Blood Pressure/ Hypertension	7	7
Low Blood Pressure/ Hypotension	7	7
Death	7	7
Dyspnea	6	6
Tachycardia	6	6
Heart Block	6	6
Respiratory Insufficiency	6	6
Complete Heart Block	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
Pulmonary Valve Stenosis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Valvular Insufficiency/ Regurgitation	2	2
Aortic Valve Insufficiency/ Regurgitation	2	2
Necrosis	2	2
Endocarditis	2	2
Congestive Heart Failure	2	2
Hemolytic Anemia	2	2
Pseudoaneurysm	2	2
Thrombosis	2	2
Pneumonia	2	2
Pneumothorax	1	1
Pulmonary Dysfunction	1	1
Pulmonary Edema	1	1
Regurgitation	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
Diminished Pulse Pressure	1	1
Alteration In Body Temperature	1	1
Patient Problem/Medical Problem	1	1
Vascular Dissection	1	1
Device Embedded In Tissue or Plaque	1	1
Perforation of Esophagus	1	1
Respiratory Tract Infection	1	1
Hematuria	1	1
Loss Of Pulse	1	1
Prolapse	1	1
Aortic Dissection	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
Pulmonary Hypertension	1	1
Renal Impairment	1	1
Unspecified Tissue Injury	1	1
Convulsion/Seizure	1	1
Movement Disorder	1	1
Cardiovascular Insufficiency	1	1