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TPLC
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Device
prosthesis, vascular graft, of 6mm and greater diameter
Product Code
DSY
Regulation Number
870.3450
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
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