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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endovascular suturing system
Definition Provides fixation and sealing between and endovascular graft and the native artery.
Product CodeOTD
Regulation Number 870.3460
Device Class 2


Premarket Reviews
ManufacturerDecision
APTUS ENDOSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
APTUS ENDOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
  GRANTED 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 16 16
2015 72 72
2016 166 166
2017 161 161
2018 215 215
2019 141 141
2020 101 101
2021 59 59
2022 52 52
2023 52 52
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 442 442
Adverse Event Without Identified Device or Use Problem 337 337
Device Dislodged or Dislocated 88 88
Fracture 56 56
Break 53 53
Malposition of Device 39 39
Device Damaged by Another Device 30 30
Activation, Positioning or Separation Problem 27 27
Device Difficult to Setup or Prepare 24 24
Material Deformation 17 17
Migration or Expulsion of Device 15 15
Insufficient Information 13 13
Difficult to Insert 13 13
Device Contamination with Chemical or Other Material 13 13
Device Operates Differently Than Expected 10 10
Component Missing 9 9
Positioning Problem 9 9
Difficult to Remove 7 7
Misfire 4 4
Detachment of Device or Device Component 4 4
Defective Device 4 4
Kinked 3 3
Patient-Device Incompatibility 3 3
Packaging Problem 3 3
Occlusion Within Device 3 3
Premature Activation 2 2
Detachment Of Device Component 2 2
Device Displays Incorrect Message 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Unfold or Unwrap 2 2
Retraction Problem 2 2
Difficult To Position 2 2
Material Twisted/Bent 2 2
Failure to Power Up 2 2
Burst Container or Vessel 2 2
Device Expiration Issue 2 2
Failure To Adhere Or Bond 2 2
Compatibility Problem 2 2
Entrapment of Device 1 1
Physical Resistance/Sticking 1 1
Use of Device Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Device Markings/Labelling Problem 1 1
Positioning Failure 1 1
Obstruction of Flow 1 1
Poor Quality Image 1 1
Unintended Power Up 1 1
Delivered as Unsterile Product 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 257 257
Injury 249 249
No Clinical Signs, Symptoms or Conditions 113 113
Death 96 96
Insufficient Information 62 62
Device Embedded In Tissue or Plaque 54 54
Pain 51 51
Blood Loss 45 45
Rupture 41 41
Unspecified Infection 40 40
Hemorrhage/Bleeding 29 29
Ischemia 28 28
Low Blood Pressure/ Hypotension 27 27
Anemia 26 26
Aneurysm 25 25
Fever 24 24
Renal Failure 24 24
Cardiac Arrest 15 15
Dyspnea 15 15
Hematoma 14 14
Obstruction/Occlusion 13 13
Abdominal Pain 13 13
Occlusion 12 12
No Known Impact Or Consequence To Patient 12 12
Embolism 12 12
Vascular Dissection 10 10
High Blood Pressure/ Hypertension 10 10
Stroke/CVA 9 9
Urinary Retention 8 8
Vomiting 8 8
Myocardial Infarction 8 8
Seroma 8 8
Air Embolism 8 8
Confusion/ Disorientation 8 8
Thrombus 8 8
Fistula 8 8
Arrhythmia 7 7
Pneumonia 6 6
Perforation of Vessels 6 6
Intimal Dissection 6 6
Respiratory Failure 6 6
Swelling 6 6
Embolism/Embolus 5 5
Nausea 5 5
Tachycardia 5 5
Urinary Tract Infection 5 5
Bradycardia 4 4
No Patient Involvement 4 4
Pseudoaneurysm 4 4
Hypoxia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular, Inc. II Sep-27-2017
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