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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)
2019 2020 2021 2022 2023 2024
34 44 50 49 50 22

MDR Year MDR Reports MDR Events
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
Adverse Event Without Identified Device or Use Problem 4797 4844
Leak/Splash 3594 3595
Insufficient Information 2036 2036
Patient-Device Incompatibility 1311 1311
Malposition of Device 937 937
Material Puncture/Hole 748 748
Migration 641 641
Fluid/Blood Leak 633 633
Material Deformation 534 534
Migration or Expulsion of Device 527 527
Activation, Positioning or Separation Problem 475 475
Material Integrity Problem 438 438
Improper or Incorrect Procedure or Method 438 438
Appropriate Term/Code Not Available 393 393
Obstruction of Flow 387 387
Off-Label Use 368 368
Detachment of Device or Device Component 355 355
Use of Device Problem 317 317
Patient Device Interaction Problem 316 316
Lack of Effect 258 258
Device Dislodged or Dislocated 232 232
Deformation Due to Compressive Stress 229 229
Fracture 225 225
Difficult to Remove 222 222
Complete Blockage 221 221
Device-Device Incompatibility 206 206
Positioning Problem 179 179
Separation Problem 175 175
Unintended Movement 141 141
Activation Failure 131 131
Partial Blockage 130 130
Device Damaged by Another Device 129 129
Difficult or Delayed Positioning 126 126
Failure to Advance 125 125
Material Separation 122 122
Physical Resistance/Sticking 109 109
Failure to Seal 96 96
Difficult to Insert 95 95
Break 91 91
Difficult to Advance 91 91
Product Quality Problem 87 87
Inadequacy of Device Shape and/or Size 79 79
Difficult or Delayed Activation 73 73
Positioning Failure 68 68
Material Twisted/Bent 61 61
Defective Component 59 59
Device Stenosis 57 57
No Apparent Adverse Event 56 56
Material Split, Cut or Torn 56 56
Microbial Contamination of Device 53 53
Difficult or Delayed Separation 49 49
Entrapment of Device 47 47
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Mechanical Jam 42 42
Misconnection 41 41
Collapse 39 39
Loss of or Failure to Bond 37 37
Activation Problem 37 37
Material Invagination 34 34
Mechanical Problem 32 32
Ejection Problem 28 28
Premature Activation 26 26
Retraction Problem 26 26
Defective Device 25 25
Short Fill 24 24
Device Markings/Labelling Problem 23 23
Failure to Eject 22 22
Stretched 22 22
Device Slipped 19 19
Device Tipped Over 18 18
Difficult to Fold, Unfold or Collapse 15 15
Material Erosion 15 15
Disconnection 15 15
Separation Failure 14 14
Device Handling Problem 14 14
Difficult to Open or Close 13 13
Filling Problem 13 13
Incomplete or Inadequate Connection 13 13
Coagulation in Device or Device Ingredient 12 12
Contamination 12 12
Therapeutic or Diagnostic Output Failure 12 12
Device Contamination with Chemical or Other Material 11 11
Crack 11 11
Material Rupture 11 11
Material Protrusion/Extrusion 10 10
Output Problem 10 10
Failure to Align 10 10
Compatibility Problem 8 8
Failure to Unfold or Unwrap 8 8
Material Fragmentation 8 8
Component Incompatible 7 7
Shipping Damage or Problem 7 7
Material Frayed 6 6
Component Missing 6 6
Structural Problem 6 6
Biocompatibility 6 6
Premature Separation 6 6
Component or Accessory Incompatibility 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Flush 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 3348 3348
No Clinical Signs, Symptoms or Conditions 2434 2435
Failure of Implant 2092 2092
Insufficient Information 1795 1795
Obstruction/Occlusion 1283 1283
Vascular Dissection 996 996
Rupture 962 962
No Consequences Or Impact To Patient 891 891
Injury 769 785
Occlusion 582 614
Pain 576 576
No Code Available 554 554
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 534 534
Death 518 531
Thrombosis/Thrombus 475 475
Ischemia 430 460
Hemorrhage/Bleeding 425 425
Unspecified Infection 383 383
Ruptured Aneurysm 352 352
No Known Impact Or Consequence To Patient 326 326
Stroke/CVA 316 332
Renal Failure 300 316
Low Blood Pressure/ Hypotension 240 240
Perforation of Vessels 193 195
Thrombus 183 183
Stenosis 178 178
Hematoma 173 175
Intimal Dissection 164 194
Cardiac Arrest 143 143
Myocardial Infarction 133 149
Fistula 126 126
Abdominal Pain 121 121
Pseudoaneurysm 106 106
Paralysis 100 100
Pneumonia 99 129
Paraplegia 92 92
Blood Loss 89 89
Aortic Dissection 86 86
Embolism/Embolus 78 78
Respiratory Failure 76 106
Thrombosis 75 75
No Information 67 67
Chest Pain 65 65
Bacterial Infection 62 62
Sepsis 60 60
Foreign Body In Patient 59 59
Fever 57 57
Embolism 53 83
Anemia 48 48
Multiple Organ Failure 48 48
Perforation 43 43
Claudication 38 38
Heart Failure/Congestive Heart Failure 34 34
Arrhythmia 33 51
High Blood Pressure/ Hypertension 32 32
Unspecified Vascular Problem 32 32
Paresis 31 31
Shock 31 31
Dyspnea 29 29
Thromboembolism 29 29
Device Embedded In Tissue or Plaque 28 28
Hemoptysis 27 27
Pleural Effusion 25 25
Pulmonary Embolism 24 24
Inflammation 23 23
Numbness 23 23
Calcium Deposits/Calcification 22 22
Unspecified Tissue Injury 19 19
Renal Impairment 18 18
Foreign Body Embolism 18 18
Necrosis 18 18
Cardiac Tamponade 16 16
Abscess 16 16
Complaint, Ill-Defined 16 16
Ulcer 15 15
Not Applicable 15 15
Disseminated Intravascular Coagulation (DIC) 15 15
Swelling/ Edema 14 14
Hematuria 13 13
Extravasation 13 13
Hypovolemic Shock 12 12
Atrial Fibrillation 12 12
Infarction, Cerebral 12 12
Great Vessel Perforation 12 12
Spinal Cord Injury 11 11
Abdominal Distention 10 10
Cardiopulmonary Arrest 10 10
Wound Dehiscence 10 10
Hemothorax 10 10
Heart Failure 9 9
Tachycardia 9 9
Local Reaction 9 9
Muscle Weakness 9 9
Pericardial Effusion 9 9
Thrombocytopenia 9 9
Ischemia Stroke 8 8
Low Cardiac Output 8 8
Nausea 8 8
Rash 7 7
Urinary Tract Infection 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Bolton Medical Inc. II Mar-27-2024
2 Bolton Medical Inc. II Jun-06-2023
3 Bolton Medical Inc. II Jan-19-2023
4 Cook Inc. II Sep-12-2020
5 Cook Inc. II Jul-10-2020
6 Cook Inc. II Jan-31-2020
7 Cook Inc. II Jun-19-2019
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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