Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, vascular graft, of 6mm and greater diameter
Product CodeDSY
Regulation Number 870.3450
Device Class 2


Premarket Reviews
ManufacturerDecision
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PECA LABS
  SUBSTANTIALLY EQUIVALENT 4
VASCUTEK LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 200 200
2019 232 232
2020 169 169
2021 168 168
2022 157 157
2023 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 147 147
Insufficient Information 109 109
Peeled/Delaminated 70 70
Obstruction of Flow 69 69
Material Split, Cut or Torn 52 52
Material Integrity Problem 50 50
Patient-Device Incompatibility 49 49
Manufacturing, Packaging or Shipping Problem 41 41
Material Puncture/Hole 38 38
Complete Blockage 32 32
Contamination 29 29
Leak/Splash 26 26
Material Separation 22 22
Microbial Contamination of Device 21 21
Product Quality Problem 21 21
Patient Device Interaction Problem 21 21
Appropriate Term/Code Not Available 19 19
Occlusion Within Device 19 19
Material Perforation 17 17
Mechanical Problem 16 16
Nonstandard Device 15 15
Partial Blockage 15 15
Use of Device Problem 13 13
Device Operates Differently Than Expected 13 13
Flaked 12 12
Fluid/Blood Leak 10 10
Material Deformation 10 10
Infusion or Flow Problem 9 9
Detachment of Device or Device Component 9 9
Device Damaged Prior to Use 9 9
Shipping Damage or Problem 8 8
Defective Device 8 8
Off-Label Use 7 7
Migration 7 7
Device Handling Problem 6 6
Torn Material 6 6
Material Rupture 6 6
Device Contamination with Chemical or Other Material 5 5
No Apparent Adverse Event 4 4
Device Stenosis 4 4
Inaccurate Information 3 3
Output Problem 3 3
Device Markings/Labelling Problem 3 3
Deformation Due to Compressive Stress 3 3
Unraveled Material 3 3
Difficult to Remove 3 3
Hole In Material 3 3
Detachment Of Device Component 2 2
Device Appears to Trigger Rejection 2 2
Delivered as Unsterile Product 2 2
Fracture 2 2
Material Fragmentation 2 2
Material Frayed 2 2
Disconnection 2 2
Break 2 2
Device Alarm System 2 2
Crack 2 2
Degraded 2 2
Stretched 2 2
Unexpected Therapeutic Results 2 2
Component Missing 2 2
Contamination /Decontamination Problem 2 2
Biocompatibility 2 2
Structural Problem 2 2
Human-Device Interface Problem 2 2
Improper Flow or Infusion 2 2
Compatibility Problem 2 2
Device Damaged by Another Device 2 2
Packaging Problem 2 2
Material Too Soft/Flexible 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Therapeutic or Diagnostic Output Failure 1 1
Material Protrusion/Extrusion 1 1
No Flow 1 1
Missing Information 1 1
Failure to Seal 1 1
Separation Failure 1 1
Physical Resistance 1 1
Activation, Positioning or Separation Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Incorrect Or Inadequate Test Results 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Material Too Rigid or Stiff 1 1
Material Discolored 1 1
Accessory Incompatible 1 1
Material Disintegration 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Device Difficult to Setup or Prepare 1 1
Migration or Expulsion of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Invagination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 125 125
No Clinical Signs, Symptoms or Conditions 110 110
No Consequences Or Impact To Patient 68 68
Thrombosis 64 64
Thrombosis/Thrombus 59 59
Blood Loss 54 54
Stenosis 54 54
Occlusion 46 46
Hemorrhage/Bleeding 44 44
Death 43 43
No Known Impact Or Consequence To Patient 39 39
Seroma 35 35
Hematoma 34 34
Pseudoaneurysm 34 34
No Patient Involvement 33 33
Obstruction/Occlusion 29 29
Bacterial Infection 25 25
Insufficient Information 24 24
No Information 23 23
No Code Available 22 22
Thrombus 19 19
Ischemia 13 13
Vascular Dissection 13 13
Pain 12 12
Aneurysm 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Inflammation 7 7
Renal Failure 7 7
Failure of Implant 7 7
Sepsis 6 6
Swelling 6 6
Failure to Anastomose 6 6
Rupture 5 5
Foreign Body In Patient 5 5
Post Operative Wound Infection 5 5
Ischemia Stroke 4 4
Heart Failure/Congestive Heart Failure 4 4
Wound Dehiscence 4 4
Abdominal Pain 4 4
Cardiac Arrest 4 4
Edema 4 4
Embolism 4 4
Exsanguination 4 4
Fever 4 4
Fistula 3 3
Hypersensitivity/Allergic reaction 3 3
Perforation of Vessels 3 3
Sudden Cardiac Death 3 3
Patient Problem/Medical Problem 2 2
Multiple Organ Failure 2 2
Quadriplegia 2 2
Not Applicable 2 2
Syncope/Fainting 2 2
Unspecified Vascular Problem 2 2
Swelling/ Edema 2 2
Rash 2 2
Local Reaction 2 2
Discharge 2 2
Infection, Indirect 2 2
Complaint, Ill-Defined 2 2
High Blood Pressure/ Hypertension 2 2
Low Blood Pressure/ Hypotension 2 2
Myocardial Infarction 2 2
Paresis 2 2
Infarction, Cerebral 2 2
Erosion 2 2
Stroke/CVA 1 1
Anemia 1 1
Chest Pain 1 1
Purulent Discharge 1 1
Embolus 1 1
Endocarditis 1 1
Erythema 1 1
Perforation 1 1
Peripheral Vascular Disease 1 1
Pneumonia 1 1
Nerve Damage 1 1
Hypovolemic Shock 1 1
Injury 1 1
Reaction 1 1
Collapse 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Sweating 1 1
Ulcer 1 1
Discomfort 1 1
Cardiogenic Shock 1 1
Heart Failure 1 1
Cardiac Tamponade 1 1
Hypovolemia 1 1
Reocclusion 1 1
Respiratory Distress 1 1
Vomiting 1 1
Weakness 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Peripheral Edema 1 1
Asystole 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Ruptured Aneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Sep-29-2021
2 Maquet Cardiovascular, LLC II Mar-10-2023
3 Maquet Cardiovascular, LLC II Jun-23-2022
4 Vascutek, Ltd. II Sep-24-2021
5 W L Gore & Associates, Inc. II Aug-13-2021
-
-