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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 14

MDR Year MDR Reports MDR Events
2014 4246 4246
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 763 763

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 13840 13841
Adverse Event Without Identified Device or Use Problem 8115 8162
Insufficient Information 3089 3089
Migration or Expulsion of Device 2062 2062
Malposition of Device 1916 1916
Patient-Device Incompatibility 1730 1730
Occlusion Within Device 1725 1725
Failure To Adhere Or Bond 1273 1273
Activation, Positioning or Separation Problem 957 957
Material Puncture/Hole 938 938
Fluid/Blood Leak 816 816
Material Integrity Problem 743 743
Hole In Material 677 677
Material Deformation 662 662
Migration 644 644
Improper or Incorrect Procedure or Method 634 634
Appropriate Term/Code Not Available 567 567
Difficult to Remove 559 559
Break 536 536
Off-Label Use 500 500
Detachment of Device or Device Component 463 463
Obstruction of Flow 460 460
Use of Device Problem 450 450
Material Separation 395 395
Fracture 379 379
Unintended Movement 371 371
Device Dislodged or Dislocated 342 342
Detachment Of Device Component 342 342
Patient Device Interaction Problem 332 332
Positioning Problem 325 325
Failure to Advance 322 322
Difficult or Delayed Positioning 282 282
Deformation Due to Compressive Stress 281 281
Kinked 279 279
Device Operates Differently Than Expected 276 276
Difficult to Advance 257 257
Lack of Effect 254 254
Complete Blockage 252 252
Positioning Failure 242 242
Partial Blockage 238 238
Device Damaged by Another Device 231 231
Loss of or Failure to Bond 228 228
Difficult To Position 227 227
Device-Device Incompatibility 209 209
Stretched 197 197
Separation Problem 179 179
Difficult to Insert 176 176
Inadequacy of Device Shape and/or Size 166 166
Activation Failure 156 156
Collapse 133 133
No Apparent Adverse Event 124 124
Product Quality Problem 119 119
Physical Resistance/Sticking 114 114
Folded 105 105
Premature Activation 96 96
Material Twisted/Bent 95 95
Entrapment of Device 92 92
Physical Resistance 90 90
Failure to Seal 89 89
Difficult or Delayed Activation 80 80
Inability to Irrigate 78 78
Retraction Problem 78 78
Defective Device 74 74
Defective Component 69 69
Human-Device Interface Problem 63 63
Material Rupture 62 62
Material Split, Cut or Torn 61 61
Torn Material 60 60
Microbial Contamination of Device 59 59
Device Stenosis 58 58
Separation Failure 58 58
Mechanical Jam 57 57
Device Slipped 52 52
Mechanical Problem 52 52
Material Invagination 51 51
Misconnection 49 49
Difficult or Delayed Separation 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 36 36
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
Therapeutic or Diagnostic Output Failure 23 23
Difficult to Open or Close 22 22
Material Erosion 22 22
Contamination 22 22
Failure to Eject 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 5595 5597
Injury 4623 4639
Failure of Implant 4585 4586
No Consequences Or Impact To Patient 3492 3492
Hemorrhage/Bleeding 2935 2938
Occlusion 2803 2836
Death 2683 2696
No Clinical Signs, Symptoms or Conditions 2395 2396
Rupture 2335 2336
Insufficient Information 1774 1774
Vascular Dissection 1698 1698
No Code Available 1526 1526
Pain 1506 1507
No Known Impact Or Consequence To Patient 1391 1391
Obstruction/Occlusion 1285 1285
Unspecified Infection 1001 1001
Ischemia 965 995
Renal Failure 750 766
Stroke/CVA 679 695
Blood Loss 653 653
Perforation of Vessels 540 542
Low Blood Pressure/ Hypotension 534 534
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 528 528
Thrombus 479 480
Thrombosis/Thrombus 474 474
Hematoma 393 395
Myocardial Infarction 381 397
Stenosis 378 378
Paralysis 348 348
Ruptured Aneurysm 348 348
No Information 323 323
Cardiac Arrest 323 324
Abdominal Pain 323 323
Thrombosis 323 323
Fistula 310 310
Aortic Dissection 300 300
Intimal Dissection 269 299
Claudication 261 261
Pseudoaneurysm 223 223
Embolism 205 235
Paraplegia 199 199
Pneumonia 189 219
Respiratory Failure 179 209
Fever 170 170
Multiple Organ Failure 161 161
Therapeutic Response, Decreased 160 160
Sepsis 141 141
Chest Pain 125 125
High Blood Pressure/ Hypertension 114 114
Foreign Body In Patient 114 114
Anemia 103 103
Not Applicable 101 101
No Patient Involvement 94 94
Bacterial Infection 92 92
Device Embedded In Tissue or Plaque 85 85
Embolism/Embolus 78 78
Calcium Deposits/Calcification 77 77
Shock 77 77
Pulmonary Embolism 72 72
Perforation 70 70
Hemoptysis 68 68
Complaint, Ill-Defined 68 68
Infarction, Cerebral 65 65
Dyspnea 63 63
Paresis 62 62
Surgical procedure, additional 61 61
Inflammation 60 60
Necrosis 58 58
Numbness 54 54
Cardiopulmonary Arrest 52 52
Cardiac Tamponade 50 50
Thromboembolism 49 49
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
Atrial Fibrillation 32 32
Hemothorax 31 31
Vomiting 31 31
Seroma 31 31
Unspecified Vascular Problem 31 31
Patient Problem/Medical Problem 29 29
Heart Failure 29 29
Neurological Deficit/Dysfunction 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
Abdominal Distention 24 24
Swelling 24 24
Disseminated Intravascular Coagulation (DIC) 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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