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TPLC
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Device
aortic valve, prosthesis, percutaneously delivered
Definition
To replace a patient's aortic 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
NPT
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
48
42
41
49
33
1
MDR Year
MDR Reports
MDR Events
2020
5806
16016
2021
5605
22452
2022
5994
27660
2023
8321
29536
2024
11047
33817
2025
1037
5917
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
13900
57209
Insufficient Information
4634
57865
Patient Device Interaction Problem
4357
9186
Perivalvular Leak
4047
4515
Device Dislodged or Dislocated
3044
3497
Degraded
1292
1292
Gradient Increase
1246
1246
Malposition of Device
1214
1214
Material Invagination
1179
1179
Fluid/Blood Leak
1153
1516
Burst Container or Vessel
1027
1027
Calcified
1012
1012
Activation Failure
951
951
Difficult to Remove
929
929
Central Regurgitation
915
915
Device Stenosis
896
909
Migration or Expulsion of Device
832
3229
Material Deformation
761
761
Difficult or Delayed Positioning
737
737
Material Split, Cut or Torn
621
621
Difficult to Open or Close
510
510
Difficult to Advance
467
467
Migration
445
501
Material Separation
418
418
Material Rupture
292
292
Failure to Advance
280
280
Material Twisted/Bent
265
265
Inadequacy of Device Shape and/or Size
247
247
Detachment of Device or Device Component
240
240
Appropriate Term/Code Not Available
232
274
Improper or Incorrect Procedure or Method
221
221
Positioning Problem
216
442
Physical Resistance/Sticking
202
202
Thickening of Material
200
200
Incomplete Coaptation
197
197
Inflation Problem
154
154
No Apparent Adverse Event
147
147
Difficult to Fold, Unfold or Collapse
146
146
Difficult to Insert
142
142
Structural Problem
134
134
Difficult or Delayed Activation
115
115
Peeled/Delaminated
111
111
Patient-Device Incompatibility
103
105
Retraction Problem
88
88
Use of Device Problem
77
77
Fracture
76
76
Leak/Splash
70
70
Off-Label Use
69
69
Backflow
68
68
Deformation Due to Compressive Stress
68
68
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6254
6254
Heart Block
4996
26908
Insufficient Information
4976
16213
Non specific EKG/ECG Changes
3074
11259
Stroke/CVA
2599
10873
Valvular Insufficiency/ Regurgitation
2374
2830
Vascular Dissection
1622
5190
Aortic Valve Insufficiency/ Regurgitation
1609
3446
Heart Failure/Congestive Heart Failure
1562
2363
Hemorrhage/Bleeding
1420
8078
Dyspnea
1400
1400
Low Blood Pressure/ Hypotension
1236
1236
Obstruction/Occlusion
1219
4207
Rupture
1144
1453
Arrhythmia
875
7360
Complete Heart Block
847
847
Cardiac Arrest
822
6331
Thrombosis/Thrombus
762
3634
Myocardial Infarction
755
5175
Aortic Valve Stenosis
713
739
Injury
660
3986
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
646
9467
No Consequences Or Impact To Patient
619
619
Death
577
1568
Atrial Fibrillation
573
2967
No Known Impact Or Consequence To Patient
511
524
Pericardial Effusion
508
508
Endocarditis
501
3211
Cardiac Tamponade
492
615
Foreign Body In Patient
480
480
Cardiac Perforation
402
2362
Bradycardia
397
397
Cardiovascular Insufficiency
330
8006
Aortic Regurgitation
327
355
Renal Failure
314
893
Perforation of Vessels
285
350
Insufficiency, Valvular
282
282
Calcium Deposits/Calcification
275
275
Blood Loss
268
423
Perforation
259
2893
Hematoma
255
2908
Stenosis
250
250
Transient Ischemic Attack
246
3447
Chest Pain
238
238
Unspecified Vascular Problem
236
1378
Unspecified Infection
230
1104
Tachycardia
218
218
Ischemia Stroke
212
4215
Ventricular Fibrillation
210
210
No Code Available
200
303
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical
II
Nov-20-2024
2
Boston Scientific Corporation
I
Jan-09-2021
3
Medtronic Heart Valves Division
II
Jul-09-2021
4
Medtronic Heart Valves Division
II
Dec-10-2020
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