TPLC - Total Product Life Cycle

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Device	pulmonary valve prosthesis percutaneously delivered
Definition	These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product Code	NPV
Device Class	Humanitarian Device Exemption

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
7	16	26	36	19	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	278	279
Patient Device Interaction Problem	232	232
Adverse Event Without Identified Device or Use Problem	164	165
Fracture	154	155
Gradient Increase	134	135
Central Regurgitation	111	112
Fluid/Blood Leak	90	95
Degraded	85	87
Device Stenosis	75	75
Perivalvular Leak	68	68
Device Dislodged or Dislocated	50	50
Malposition of Device	47	51
Structural Problem	40	40
Burst Container or Vessel	38	41
Difficult to Open or Close	32	33
Migration	30	30
Difficult to Remove	28	28
Difficult or Delayed Positioning	27	28
Activation Failure	25	25
Material Separation	24	25
Appropriate Term/Code Not Available	24	24
Migration or Expulsion of Device	22	22
Thickening of Material	22	22
Calcified	20	20
Inadequacy of Device Shape and/or Size	19	19
Material Deformation	17	18
No Apparent Adverse Event	17	17
Incomplete Coaptation	16	18
Difficult to Advance	14	16
Material Split, Cut or Torn	13	13
Material Invagination	8	8
Partial Blockage	8	8
Deformation Due to Compressive Stress	8	8
Device Damaged by Another Device	7	7
Inflation Problem	7	8
Material Rupture	7	7
Detachment of Device or Device Component	6	6
Obstruction of Flow	6	6
Material Integrity Problem	5	5
Deflation Problem	5	6
Patient-Device Incompatibility	4	4
Mechanical Problem	4	4
Product Quality Problem	4	4
Mechanics Altered	4	4
Device Slipped	4	4
Failure to Advance	3	3
Flushing Problem	3	3
Backflow	3	3
Reflux within Device	3	3
Difficult or Delayed Activation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	422	433
No Clinical Signs, Symptoms or Conditions	330	335
Pulmonary Valve Insufficiency/ Regurgitation	118	119
Endocarditis	111	111
Pulmonary Valve Stenosis	110	110
Non specific EKG/ECG Changes	72	72
Valvular Insufficiency/ Regurgitation	55	55
Dyspnea	52	53
Obstruction/Occlusion	51	52
Thrombosis/Thrombus	50	50
Tachycardia	50	50
Hemorrhage/Bleeding	37	37
Heart Failure/Congestive Heart Failure	31	31
Tricuspid Valve Insufficiency/ Regurgitation	30	30
Arrhythmia	28	29
Chest Pain	25	25
Cardiac Arrest	23	23
No Information	22	22
Fever	21	21
Stenosis	21	21
Cardiovascular Insufficiency	20	20
Fatigue	18	19
Rupture	16	16
Heart Block	16	16
Sepsis	16	16
Low Blood Pressure/ Hypotension	16	16
Mitral Valve Stenosis	14	14
Unspecified Infection	13	13
Foreign Body In Patient	13	15
Ventricular Fibrillation	13	13
Mitral Valve Insufficiency/ Regurgitation	12	12
No Consequences Or Impact To Patient	11	11
Pericardial Effusion	11	11
Hematoma	10	10
Great Vessel Perforation	10	10
Pulmonary Regurgitation	10	10
No Known Impact Or Consequence To Patient	10	12
High Blood Pressure/ Hypertension	9	9
Bradycardia	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	11
Pulmonary Edema	9	10
Unspecified Tissue Injury	9	9
Vascular Dissection	8	8
Bacterial Infection	8	8
Valvular Stenosis	8	8
Abscess	8	8
Unspecified Heart Problem	8	8
Pulmonary Embolism	7	7
Perforation	7	7
Stroke/CVA	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc	I	Apr-18-2022