TPLC - Total Product Life Cycle

• Device: pulmonic valved conduit
• Product Code: MWH
• Device Class: Humanitarian Device Exemption

MDR Year	MDR Reports	MDR Events
2019	128	128
2020	83	83
2021	79	79
2022	67	67
2023	57	57
2024	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	287	287
Gradient Increase	63	63
Calcified	44	44
Adverse Event Without Identified Device or Use Problem	36	36
Obstruction of Flow	28	28
Inadequacy of Device Shape and/or Size	15	15
Patient Device Interaction Problem	13	13
Material Deformation	11	11
Degraded	10	10
Partial Blockage	6	6
Incomplete Coaptation	6	6
Device Markings/Labelling Problem	4	4
Stretched	4	4
Material Split, Cut or Torn	4	4
Central Regurgitation	4	4
No Apparent Adverse Event	3	3
Reflux within Device	3	3
Peeled/Delaminated	2	2
Device Stenosis	2	2
Thickening of Material	2	2
Biocompatibility	2	2
Fracture	2	2
Expiration Date Error	1	1
Material Twisted/Bent	1	1
Patient-Device Incompatibility	1	1
Material Integrity Problem	1	1
Deformation Due to Compressive Stress	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Perivalvular Leak	1	1
Material Erosion	1	1
Defective Device	1	1
Break	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pulmonary Valve Stenosis	151	151
Insufficient Information	127	127
No Information	118	118
Pulmonary Valve Insufficiency/ Regurgitation	62	62
Endocarditis	50	50
Pulmonary Regurgitation	37	37
Pulmonary Insufficiency	21	21
Obstruction/Occlusion	17	17
Non specific EKG/ECG Changes	15	15
Stenosis	14	14
Calcium Deposits/Calcification	13	13
Aneurysm	10	10
Unspecified Infection	10	10
Thrombosis/Thrombus	9	9
Blood Loss	8	8
Thrombus	8	8
Sepsis	7	7
Stroke/CVA	7	7
Hemorrhage/Bleeding	7	7
Low Cardiac Output	7	7
Regurgitation, Valvular	6	6
Death	6	6
Tachycardia	5	5
Low Blood Pressure/ Hypotension	5	5
Pleural Effusion	5	5
Pseudoaneurysm	5	5
Complete Heart Block	5	5
Thromboembolism	5	5
Heart Block	5	5
Heart Failure/Congestive Heart Failure	5	5
Fibrosis	4	4
No Known Impact Or Consequence To Patient	4	4
Ventricular Fibrillation	4	4
Cardiac Arrest	4	4
Dyspnea	4	4
Fever	4	4
Aortic Valve Stenosis	4	4
Abscess	4	4
Pulmonary Embolism	3	3
Intimal Dissection	3	3
Arrhythmia	3	3
Aortic Regurgitation	3	3
Hematoma	3	3
Bradycardia	3	3
Ventricular Tachycardia	3	3
Myocardial Infarction	3	3
High Blood Pressure/ Hypertension	3	3
Vascular System (Circulation), Impaired	3	3
Pericardial Effusion	3	3
Unspecified Heart Problem	3	3
Respiratory Insufficiency	3	3
Myocardial Hypertrophy	2	2
Valvular Insufficiency/ Regurgitation	2	2
Embolism/Embolus	2	2
Cardiovascular Insufficiency	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Inflammation	2	2
Mitral Valve Stenosis	2	2
Pneumonia	2	2
Pulmonary Infarction	2	2
Renal Failure	2	2
Right Ventricular Dysfunction	2	2
Vomiting	2	2
Rupture	2	2
Thrombosis	2	2
Tricuspid Valve Stenosis	2	2
Diarrhea	2	2
Fistula	2	2
Erosion	2	2
Aortic Insufficiency	2	2
Atrial Fibrillation	2	2
Bacterial Infection	1	1
Corneal Pannus	1	1
Wound Dehiscence	1	1
Host-Tissue Reaction	1	1
Abdominal Pain	1	1
Adhesion(s)	1	1
Anemia	1	1
Foreign Body Reaction	1	1
Headache	1	1
Hemoptysis	1	1
Hemostasis	1	1
Hyperglycemia	1	1
Fatigue	1	1
Death, Intrauterine Fetal	1	1
Tricuspid Regurgitation	1	1
Shock	1	1
Cardiac Tamponade	1	1
Myalgia	1	1
Regurgitation	1	1
Cardiogenic Shock	1	1
Seizures	1	1
Respiratory Distress	1	1
Pulmonary Edema	1	1
Nausea	1	1
Neurological Deficit/Dysfunction	1	1
Mitral Regurgitation	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Convulsion/Seizure	1	1
No Code Available	1	1