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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)
2018 2019 2020 2021 2022 2023
39 34 44 50 49 18

MDR Year MDR Reports MDR Events
2018 4177 4177
2019 3592 3619
2020 3057 3075
2021 3699 3702
2022 3459 3459
2023 1507 1507

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4968 4969
Adverse Event Without Identified Device or Use Problem 4931 4978
Insufficient Information 1957 1957
Patient-Device Incompatibility 1256 1256
Malposition of Device 886 886
Material Puncture/Hole 844 844
Migration or Expulsion of Device 732 732
Material Integrity Problem 645 645
Fluid/Blood Leak 575 575
Activation, Positioning or Separation Problem 523 523
Migration 496 496
Material Deformation 496 496
Improper or Incorrect Procedure or Method 444 444
Appropriate Term/Code Not Available 434 434
Use of Device Problem 347 347
Off-Label Use 344 344
Obstruction of Flow 320 320
Detachment of Device or Device Component 315 315
Patient Device Interaction Problem 270 270
Failure To Adhere Or Bond 261 261
Deformation Due to Compressive Stress 250 250
Device Dislodged or Dislocated 228 228
Complete Blockage 226 226
Difficult to Remove 222 222
Loss of or Failure to Bond 218 218
Fracture 216 216
Unintended Movement 172 172
Partial Blockage 164 164
Device-Device Incompatibility 164 164
Separation Problem 155 155
Difficult or Delayed Positioning 150 150
Occlusion Within Device 144 144
Positioning Problem 144 144
Material Separation 141 141
Device Damaged by Another Device 131 131
Failure to Advance 131 131
Hole In Material 123 123
Product Quality Problem 117 117
Activation Failure 112 112
Break 108 108
Difficult to Insert 105 105
Physical Resistance/Sticking 98 98
Difficult to Advance 96 96
Lack of Effect 92 92
No Apparent Adverse Event 87 87
Inadequacy of Device Shape and/or Size 85 85
Stretched 76 76
Positioning Failure 65 65
Difficult or Delayed Activation 63 63
Material Twisted/Bent 60 60
Material Split, Cut or Torn 57 57
Collapse 55 55
Defective Component 53 53
Entrapment of Device 49 49
Misconnection 49 49
Detachment Of Device Component 47 47
Microbial Contamination of Device 47 47
Device Stenosis 47 47
Mechanical Jam 43 43
Loosening of Implant Not Related to Bone-Ingrowth 41 41
Device Operates Differently Than Expected 40 40
Mechanical Problem 36 36
Material Invagination 34 34
Activation Problem 31 31
Kinked 30 30
Difficult To Position 30 30
Retraction Problem 28 28
Premature Activation 27 27
Device Slipped 25 25
Defective Device 24 24
Difficult or Delayed Separation 23 23
Human-Device Interface Problem 20 20
Device Markings/Labelling Problem 19 19
Disconnection 18 18
Failure to Eject 17 17
Material Erosion 16 16
Short Fill 16 16
Compatibility Problem 16 16
Device Tipped Over 16 16
Material Rupture 15 15
Device Handling Problem 15 15
Difficult to Fold, Unfold or Collapse 14 14
Difficult to Open or Close 14 14
Material Protrusion/Extrusion 13 13
Incomplete or Inadequate Connection 13 13
Therapeutic or Diagnostic Output Failure 12 12
Device Contamination with Chemical or Other Material 12 12
Separation Failure 12 12
Bent 12 12
Material Frayed 11 11
Coagulation in Device or Device Ingredient 10 10
Contamination 10 10
Crack 10 10
Output Problem 10 10
Ejection Problem 9 9
Filling Problem 9 9
Failure to Align 9 9
Biocompatibility 9 9
Folded 8 8
Failure to Unfold or Unwrap 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 3732 3732
Failure of Implant 3134 3134
No Clinical Signs, Symptoms or Conditions 1884 1885
No Consequences Or Impact To Patient 1428 1428
Injury 1404 1420
Insufficient Information 1386 1386
Rupture 1076 1076
Occlusion 940 972
Obstruction/Occlusion 915 915
Vascular Dissection 880 880
Death 862 875
No Code Available 837 837
Pain 694 694
No Known Impact Or Consequence To Patient 570 570
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 478 478
Hemorrhage/Bleeding 466 466
Unspecified Infection 428 428
Ischemia 428 458
Thrombosis/Thrombus 347 347
Renal Failure 337 353
Stroke/CVA 324 340
Low Blood Pressure/ Hypotension 288 288
Thrombus 260 260
Ruptured Aneurysm 257 257
Intimal Dissection 233 263
Perforation of Vessels 216 218
Stenosis 198 198
No Information 182 182
Blood Loss 174 174
Aortic Dissection 169 169
Hematoma 165 167
Cardiac Arrest 153 153
Myocardial Infarction 151 167
Abdominal Pain 143 143
Thrombosis 133 133
Fistula 124 124
Paralysis 123 123
Pseudoaneurysm 108 108
Pneumonia 102 132
Claudication 97 97
Paraplegia 89 89
Respiratory Failure 83 113
Embolism 66 96
Embolism/Embolus 65 65
Fever 62 62
Chest Pain 62 62
Anemia 60 60
Sepsis 59 59
Bacterial Infection 54 54
Multiple Organ Failure 54 54
Perforation 53 53
Not Applicable 49 49
Foreign Body In Patient 46 46
High Blood Pressure/ Hypertension 41 41
Device Embedded In Tissue or Plaque 38 38
Arrhythmia 35 53
Shock 34 34
Inflammation 33 33
Pulmonary Embolism 33 33
Dyspnea 31 31
Thromboembolism 29 29
Numbness 29 29
Calcium Deposits/Calcification 28 28
Pleural Effusion 27 27
Paresis 27 27
Hemoptysis 26 26
Unspecified Vascular Problem 26 26
Heart Failure/Congestive Heart Failure 25 25
Abscess 21 21
Atrial Fibrillation 20 20
Infarction, Cerebral 20 20
Necrosis 20 20
Cardiac Tamponade 19 19
Ulcer 17 17
Complaint, Ill-Defined 17 17
Hematuria 17 17
Hypovolemic Shock 17 17
Unspecified Tissue Injury 17 17
Hemothorax 15 15
Extravasation 15 15
Disseminated Intravascular Coagulation (DIC) 14 14
Cardiopulmonary Arrest 14 14
Urinary Tract Infection 14 14
Heart Failure 14 14
Vomiting 13 13
Pericardial Effusion 13 13
Foreign Body Embolism 11 11
Confusion/ Disorientation 11 11
Great Vessel Perforation 11 11
Wound Dehiscence 11 11
Nausea 11 11
Tachycardia 11 11
Low Cardiac Output 10 10
No Patient Involvement 10 10
Vascular System (Circulation), Impaired 9 9
Cognitive Changes 9 9
Loss of consciousness 9 9
Weakness 9 9
Urinary Retention 9 9
Rash 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Bolton Medical Inc. II Jun-06-2023
2 Bolton Medical Inc. II Jan-19-2023
3 Cook Inc. II Sep-12-2020
4 Cook Inc. II Jul-10-2020
5 Cook Inc. II Jan-31-2020
6 Cook Inc. II Jun-19-2019
7 Endologix I Oct-03-2018
8 Endologix, Inc. I Jun-11-2020
9 Medtronic Vascular, Inc. II Feb-18-2022
10 Medtronic Vascular, Inc. II Nov-24-2021
11 Medtronic Vascular, Inc. II Jul-23-2021
12 Medtronic Vascular, Inc. II Jun-28-2021
13 Medtronic Vascular, Inc. I Mar-10-2021
14 W L Gore & Associates, Inc. II Oct-23-2020
15 W L Gore & Associates, Inc. II Oct-23-2020
16 W L Gore & Associates, Inc. II May-20-2020
17 W. L. Gore & Associates Inc. II Feb-04-2020
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