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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
0
MDR Year
MDR Reports
MDR Events
2020
112
112
2021
153
153
2022
191
191
2023
253
253
2024
326
326
2025
40
40
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
247
247
Patient Device Interaction Problem
156
156
Adverse Event Without Identified Device or Use Problem
151
151
Fracture
133
133
Gradient Increase
114
114
Fluid/Blood Leak
76
76
Central Regurgitation
72
72
Degraded
60
60
Perivalvular Leak
54
54
Device Stenosis
53
53
Malposition of Device
41
41
Burst Container or Vessel
30
30
Device Dislodged or Dislocated
28
28
Migration
28
28
Difficult to Open or Close
26
26
Material Separation
23
23
Structural Problem
21
21
Difficult to Remove
18
18
Difficult or Delayed Positioning
18
18
Migration or Expulsion of Device
17
17
Activation Failure
17
17
Incomplete Coaptation
16
16
Thickening of Material
16
16
Inadequacy of Device Shape and/or Size
15
15
Appropriate Term/Code Not Available
15
15
Calcified
15
15
Difficult to Advance
14
14
Material Deformation
14
14
No Apparent Adverse Event
11
11
Material Split, Cut or Torn
10
10
Partial Blockage
8
8
Material Rupture
6
6
Device Damaged by Another Device
6
6
Deformation Due to Compressive Stress
6
6
Inflation Problem
6
6
Obstruction of Flow
6
6
Material Invagination
5
5
Deflation Problem
5
5
Detachment of Device or Device Component
5
5
Patient-Device Incompatibility
4
4
Mechanical Problem
4
4
Material Integrity Problem
3
3
Backflow
3
3
Reflux within Device
3
3
Device Slipped
3
3
Positioning Failure
2
2
Positioning Problem
2
2
Physical Resistance/Sticking
2
2
Packaging Problem
2
2
Off-Label Use
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
361
361
No Clinical Signs, Symptoms or Conditions
245
245
Pulmonary Valve Stenosis
103
103
Pulmonary Valve Insufficiency/ Regurgitation
102
102
Endocarditis
96
96
Non specific EKG/ECG Changes
59
59
Obstruction/Occlusion
43
43
Valvular Insufficiency/ Regurgitation
43
43
Tachycardia
37
37
Thrombosis/Thrombus
37
37
Dyspnea
37
37
Hemorrhage/Bleeding
29
29
Heart Failure/Congestive Heart Failure
25
25
No Information
22
22
Tricuspid Valve Insufficiency/ Regurgitation
22
22
Cardiovascular Insufficiency
19
19
Chest Pain
19
19
Arrhythmia
18
18
Stenosis
17
17
Fever
16
16
Cardiac Arrest
16
16
Heart Block
15
15
Rupture
14
14
Mitral Valve Stenosis
13
13
Sepsis
13
13
Fatigue
13
13
Unspecified Infection
12
12
No Consequences Or Impact To Patient
11
11
Low Blood Pressure/ Hypotension
10
10
No Known Impact Or Consequence To Patient
10
10
Pulmonary Regurgitation
10
10
Ventricular Fibrillation
9
9
Mitral Valve Insufficiency/ Regurgitation
9
9
Pulmonary Edema
8
8
Valvular Stenosis
8
8
Unspecified Tissue Injury
8
8
Bacterial Infection
8
8
High Blood Pressure/ Hypertension
7
7
Hematoma
7
7
Aortic Valve Insufficiency/ Regurgitation
7
7
Stroke/CVA
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Foreign Body In Patient
7
7
Great Vessel Perforation
7
7
Vascular Dissection
6
6
Bradycardia
6
6
Injury
6
6
Pulmonary Embolism
5
5
Cardiac Tamponade
5
5
Death
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Inc
I
Apr-18-2022
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