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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, endovascular graft, aortic aneurysm treatment
Product CodeMIH
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
49 46 64 57 48 80 53 47 41 39 34 44 50 49 50 18

MDR Year MDR Reports MDR Events
2014 4248 4248
2015 4470 4470
2016 4296 4296
2017 4105 4105
2018 4178 4178
2019 3592 3619
2020 3057 3075
2021 3686 3689
2022 3455 3455
2023 3562 3562
2024 1012 1012

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 13884 13885
Adverse Event Without Identified Device or Use Problem 8193 8240
Insufficient Information 3099 3099
Migration or Expulsion of Device 2067 2067
Malposition of Device 1939 1939
Patient-Device Incompatibility 1751 1751
Occlusion Within Device 1725 1725
Failure To Adhere Or Bond 1273 1273
Activation, Positioning or Separation Problem 961 961
Material Puncture/Hole 945 945
Fluid/Blood Leak 825 825
Material Integrity Problem 743 743
Hole In Material 677 677
Material Deformation 675 675
Migration 666 666
Improper or Incorrect Procedure or Method 638 638
Appropriate Term/Code Not Available 573 573
Difficult to Remove 563 563
Break 537 537
Off-Label Use 509 509
Detachment of Device or Device Component 470 470
Obstruction of Flow 464 464
Use of Device Problem 450 450
Material Separation 397 397
Fracture 381 381
Unintended Movement 371 371
Device Dislodged or Dislocated 344 344
Detachment Of Device Component 342 342
Patient Device Interaction Problem 339 339
Positioning Problem 331 331
Failure to Advance 325 325
Deformation Due to Compressive Stress 284 284
Difficult or Delayed Positioning 282 282
Kinked 279 279
Device Operates Differently Than Expected 276 276
Lack of Effect 263 263
Difficult to Advance 258 258
Complete Blockage 252 252
Positioning Failure 243 243
Partial Blockage 239 239
Device Damaged by Another Device 232 232
Loss of or Failure to Bond 228 228
Difficult To Position 227 227
Device-Device Incompatibility 215 215
Stretched 197 197
Separation Problem 180 180
Difficult to Insert 177 177
Inadequacy of Device Shape and/or Size 166 166
Activation Failure 159 159
Collapse 134 134
No Apparent Adverse Event 124 124
Product Quality Problem 119 119
Physical Resistance/Sticking 115 115
Folded 105 105
Failure to Seal 96 96
Premature Activation 96 96
Material Twisted/Bent 95 95
Entrapment of Device 93 93
Physical Resistance 90 90
Difficult or Delayed Activation 80 80
Inability to Irrigate 78 78
Retraction Problem 78 78
Defective Device 75 75
Defective Component 69 69
Human-Device Interface Problem 63 63
Material Split, Cut or Torn 62 62
Material Rupture 62 62
Torn Material 60 60
Microbial Contamination of Device 59 59
Device Stenosis 58 58
Separation Failure 58 58
Mechanical Jam 57 57
Material Invagination 53 53
Device Slipped 52 52
Mechanical Problem 52 52
Difficult or Delayed Separation 50 50
Misconnection 49 49
Disconnection 46 46
Loosening of Implant Not Related to Bone-Ingrowth 45 45
Device Markings/Labelling Problem 42 42
Component or Accessory Incompatibility 40 40
Sticking 38 38
Activation Problem 37 37
Device Contamination with Chemical or Other Material 31 31
Bent 31 31
Material Frayed 31 31
Inaccurate Delivery 30 30
Filling Problem 28 28
Ejection Problem 28 28
Device Handling Problem 26 26
Compatibility Problem 25 25
Material Protrusion/Extrusion 25 25
Device Expiration Issue 25 25
Short Fill 25 25
Failure to Unfold or Unwrap 25 25
Difficult to Open or Close 23 23
Therapeutic or Diagnostic Output Failure 23 23
Failure to Eject 22 22
Material Erosion 22 22
Contamination 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 5606 5608
Injury 4623 4639
Failure of Implant 4589 4590
No Consequences Or Impact To Patient 3492 3492
Hemorrhage/Bleeding 2939 2942
Occlusion 2803 2836
Death 2683 2696
No Clinical Signs, Symptoms or Conditions 2439 2440
Rupture 2347 2348
Insufficient Information 1809 1809
Vascular Dissection 1724 1724
No Code Available 1526 1526
Pain 1513 1514
No Known Impact Or Consequence To Patient 1391 1391
Obstruction/Occlusion 1308 1308
Unspecified Infection 1003 1003
Ischemia 974 1004
Renal Failure 753 769
Stroke/CVA 685 701
Blood Loss 653 653
Perforation of Vessels 541 543
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 536 536
Low Blood Pressure/ Hypotension 534 534
Thrombosis/Thrombus 482 482
Thrombus 479 480
Hematoma 394 396
Myocardial Infarction 382 398
Stenosis 380 380
Ruptured Aneurysm 355 355
Paralysis 352 352
Cardiac Arrest 326 327
Abdominal Pain 326 326
Thrombosis 323 323
No Information 323 323
Fistula 312 312
Aortic Dissection 300 300
Intimal Dissection 269 299
Claudication 261 261
Pseudoaneurysm 224 224
Embolism 205 235
Paraplegia 202 202
Pneumonia 189 219
Respiratory Failure 181 211
Fever 171 171
Multiple Organ Failure 162 162
Therapeutic Response, Decreased 160 160
Sepsis 141 141
Chest Pain 127 127
High Blood Pressure/ Hypertension 115 115
Foreign Body In Patient 115 115
Anemia 104 104
Not Applicable 101 101
No Patient Involvement 94 94
Bacterial Infection 93 93
Device Embedded In Tissue or Plaque 85 85
Shock 79 79
Calcium Deposits/Calcification 78 78
Embolism/Embolus 78 78
Pulmonary Embolism 72 72
Perforation 70 70
Hemoptysis 69 69
Complaint, Ill-Defined 68 68
Infarction, Cerebral 65 65
Dyspnea 63 63
Paresis 62 62
Inflammation 61 61
Surgical procedure, additional 61 61
Necrosis 58 58
Numbness 54 54
Cardiopulmonary Arrest 52 52
Cardiac Tamponade 50 50
Thromboembolism 50 50
Arrhythmia 48 66
Vascular System (Circulation), Impaired 46 46
Pleural Effusion 45 45
Hypovolemic Shock 41 41
Abscess 39 39
Weakness 39 39
Tissue Damage 37 37
Ulcer 37 37
Test Result 34 34
Heart Failure/Congestive Heart Failure 34 34
Unspecified Vascular Problem 32 32
Atrial Fibrillation 32 32
Hemothorax 31 31
Seroma 31 31
Vomiting 31 31
Heart Failure 29 29
Neurological Deficit/Dysfunction 29 29
Patient Problem/Medical Problem 29 29
Extravasation 28 28
Other (for use when an appropriate patient code cannot be identified) 27 27
Reaction 27 27
Loss Of Pulse 27 27
Disseminated Intravascular Coagulation (DIC) 25 25
Swelling 24 24
Abdominal Distention 24 24
Wound Dehiscence 23 23
Bradycardia 21 21
Tachycardia 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Nov-05-2015
2 Bolton Medical Inc. II Mar-27-2024
3 Bolton Medical Inc. II Jun-06-2023
4 Bolton Medical Inc. II Jan-19-2023
5 Cook Inc. II Sep-12-2020
6 Cook Inc. II Jul-10-2020
7 Cook Inc. II Jan-31-2020
8 Cook Inc. II Jun-19-2019
9 Cook Medical Incorporated I Aug-10-2017
10 Cook, Inc. III Sep-06-2011
11 Endologix I Oct-03-2018
12 Endologix II Jan-19-2017
13 Endologix II Jan-19-2017
14 Endologix II Jan-19-2017
15 Endologix II Jan-19-2017
16 Endologix II Jan-18-2017
17 Endologix II Jan-18-2017
18 Endologix II Jan-18-2017
19 Endologix, Inc. I Jun-11-2020
20 Medtronic Vascular, Inc. II Feb-18-2022
21 Medtronic Vascular, Inc. II Nov-24-2021
22 Medtronic Vascular, Inc. II Jul-23-2021
23 Medtronic Vascular, Inc. II Jun-28-2021
24 Medtronic Vascular, Inc. I Mar-10-2021
25 Medtronic Vascular, Inc. II Mar-15-2017
26 Medtronic Vascular, Inc. II Oct-25-2013
27 Medtronic Vascular, Inc. II Mar-23-2012
28 Trivascular, Inc I Nov-03-2014
29 Trivascular, Inc II Mar-26-2014
30 Trivascular, Inc II Nov-13-2012
31 W L Gore & Associates, Inc. II Oct-23-2020
32 W L Gore & Associates, Inc. II Oct-23-2020
33 W L Gore & Associates, Inc. II May-20-2020
34 W L Gore & Associates, Inc. II Oct-25-2017
35 W. L. Gore & Associates Inc. II Feb-04-2020
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