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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventricular (assist) bypass
Definition Approved pma: P870072
Product CodeDSQ
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
36 35 34 48 38 28

MDR Year MDR Reports MDR Events
2017 9055 9055
2018 12660 12660
2019 20216 20216
2020 14238 14238
2021 15766 15766
2022 12089 12089

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43824 43824
Battery Problem 5979 5979
Pumping Problem 5587 5587
Power Problem 5046 5046
Mechanical Problem 3919 3919
Infusion or Flow Problem 3268 3268
Break 3181 3181
Pumping Stopped 2852 2852
Connection Problem 2155 2155
Material Integrity Problem 2000 2000
Obstruction of Flow 1459 1459
Electrical /Electronic Property Problem 1153 1153
Disconnection 1143 1143
Complete Loss of Power 1120 1120
Material Twisted/Bent 1118 1118
Electrical Power Problem 1118 1118
Decreased Pump Speed 963 963
Device Stops Intermittently 942 942
Material Split, Cut or Torn 921 921
Insufficient Information 845 845
High Readings 745 745
Material Deformation 724 724
Loose or Intermittent Connection 658 658
Use of Device Problem 446 446
Device Displays Incorrect Message 422 422
Communication or Transmission Problem 393 393
No Apparent Adverse Event 346 346
Display or Visual Feedback Problem 334 334
Noise, Audible 306 306
Malposition of Device 299 299
Device Difficult to Setup or Prepare 283 283
Appropriate Term/Code Not Available 264 264
Loss of Power 257 257
Increase in Suction 256 256
Naturally Worn 233 233
Device Alarm System 222 222
Output Problem 212 212
No Audible Alarm 201 201
Partial Blockage 200 200
Overheating of Device 186 186
Protective Measures Problem 184 184
Restricted Flow rate 180 180
Data Problem 161 161
Improper or Incorrect Procedure or Method 158 158
Date/Time-Related Software Problem 132 132
Electrical Shorting 131 131
No Display/Image 128 128
Failure to Charge 117 117
Device Inoperable 116 116
Crack 115 115
Leak/Splash 111 111
Failure to Pump 105 105
Failure to Power Up 104 104
Fluid Leak 96 96
Insufficient Flow or Under Infusion 87 87
Failure to Align 77 77
Contamination 73 73
Device Operates Differently Than Expected 70 70
Detachment of Device or Device Component 69 69
Deformation Due to Compressive Stress 69 69
Kinked 67 67
Low Readings 65 65
Incomplete or Inadequate Connection 64 64
Device Fell 59 59
Electro-Static Discharge 58 58
Fracture 56 56
Low Audible Alarm 55 55
Material Discolored 53 53
Torn Material 53 53
Contamination /Decontamination Problem 52 52
Vibration 51 51
Alarm Not Visible 47 47
Electromagnetic Interference 42 42
Occlusion Within Device 42 42
Device Contamination with Chemical or Other Material 42 42
Difficult to Remove 41 41
Material Separation 41 41
Bent 41 41
Unintended Electrical Shock 38 38
Corroded 35 35
Migration or Expulsion of Device 32 32
Unexpected Shutdown 31 31
Cut In Material 30 30
Premature Discharge of Battery 29 29
Display Difficult to Read 28 28
Fitting Problem 28 28
Moisture Damage 28 28
Device Damaged Prior to Use 27 27
Therapeutic or Diagnostic Output Failure 27 27
Microbial Contamination of Device 26 26
Component Missing 25 25
Misconnection 24 24
Charging Problem 24 24
Improper Flow or Infusion 23 23
Material Protrusion/Extrusion 23 23
Maintenance Does Not Comply To Manufacturers Recommendations 23 23
Failure to Interrogate 22 22
Misassembled 21 21
Increased Pump Speed 21 21
Failure of Device to Self-Test 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13818 13819
No Clinical Signs, Symptoms or Conditions 11636 11636
Blood Loss 8872 8873
No Consequences Or Impact To Patient 7394 7394
Unspecified Infection 6763 6763
Death 5966 5966
Thrombus 4353 4353
Hemolysis 4062 4063
Stroke/CVA 2883 2883
Bacterial Infection 2870 2870
Hemorrhage/Bleeding 2456 2456
Heart Failure/Congestive Heart Failure 2025 2025
Thrombosis/Thrombus 2021 2021
Sepsis 1838 1838
Arrhythmia 1837 1837
Renal Failure 1738 1738
Insufficient Information 1669 1669
Respiratory Failure 1578 1578
Neurological Deficit/Dysfunction 1436 1436
Gastrointestinal Hemorrhage 1425 1425
Hemorrhage, Cerebral 1310 1310
Skin Infection 1145 1145
Anemia 1055 1055
Heart Failure 1025 1025
Dyspnea 890 890
Infarction, Cerebral 794 794
Thrombosis 788 788
Multiple Organ Failure 748 748
Hematuria 738 739
Post Operative Wound Infection 708 708
Dizziness 707 707
Intracranial Hemorrhage 679 680
Right Ventricular Failure 652 652
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 630 630
Tachycardia 604 604
Fever 602 602
Thromboembolism 570 570
High Blood Pressure/ Hypertension 548 548
Fatigue 538 538
Unspecified Nervous System Problem 520 520
Cardiac Arrest 515 515
Weakness 480 480
Hemorrhagic Stroke 477 477
Low Blood Pressure/ Hypotension 469 469
Atrial Fibrillation 460 460
Hematoma 453 453
Hypervolemia 445 445
No Code Available 437 437
Pain 428 428
Ventricular Tachycardia 409 409
Lactate Dehydrogenase Increased 409 409
Cardiogenic Shock 385 385
Syncope/Fainting 382 382
Syncope 350 350
Wound Dehiscence 341 341
Muscle Weakness 337 337
Ischemia Stroke 321 321
Transient Ischemic Attack 318 318
Fall 297 297
Obstruction/Occlusion 294 294
Confusion/ Disorientation 292 292
Loss of consciousness 290 290
Pleural Effusion 287 287
Headache 284 284
Pneumonia 278 278
Ventricular Fibrillation 273 273
Chest Pain 267 267
Nausea 262 262
No Patient Involvement 262 262
Cardiac Tamponade 233 233
Complaint, Ill-Defined 232 232
Ischemia 229 229
Liver Damage/Dysfunction 224 224
Vomiting 222 222
Septic Shock 215 215
Hemorrhage, Subarachnoid 215 215
Encephalopathy 211 211
Purulent Discharge 198 198
Pericardial Effusion 197 197
Aortic Insufficiency 196 196
Aortic Valve Insufficiency/ Regurgitation 192 192
Abdominal Pain 189 189
Melena 185 185
Hypovolemia 182 182
Epistaxis 176 176
Renal Impairment 173 173
Hypoxia 162 162
Seizures 158 158
Right Ventricular Dysfunction 156 156
Anxiety 155 155
No Information 148 148
Dehydration 136 136
Dysphasia 131 131
Swelling/ Edema 127 127
Convulsion/Seizure 125 125
Abscess 121 121
Coma 117 117
Pulmonary Edema 115 115
Edema 112 112
Fungal Infection 112 112

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I May-17-2018
2 Heartware I May-21-2018
3 Heartware I Apr-27-2017
4 Heartware I Apr-25-2017
5 Heartware, Inc. I Aug-18-2022
6 Heartware, Inc. II May-17-2022
7 Heartware, Inc. II Mar-04-2022
8 Heartware, Inc. II Sep-16-2021
9 Heartware, Inc. I Aug-06-2021
10 Heartware, Inc. II Jul-13-2021
11 Heartware, Inc. II Apr-21-2021
12 Heartware, Inc. II Apr-20-2021
13 Heartware, Inc. I Apr-16-2021
14 Heartware, Inc. I Apr-06-2021
15 Heartware, Inc. I May-22-2020
16 Heartware, Inc. I Mar-09-2020
17 Heartware, Inc. II Dec-07-2018
18 Heartware, Inc. II Oct-03-2018
19 Jarvik Heart Inc II Dec-18-2018
20 Medtronic Inc I Jun-21-2022
21 Medtronic Inc I Jun-03-2022
22 Medtronic Inc II May-17-2022
23 Medtronic Inc I Feb-04-2021
24 Thoratec Corp. II Nov-26-2021
25 Thoratec Corp. II Dec-27-2019
26 Thoratec Corp. II Aug-22-2019
27 Thoratec Corp. II Apr-19-2019
28 Thoratec Corporation I May-24-2017
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