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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
ATRIUM MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
PECA LABS
SUBSTANTIALLY EQUIVALENT
3
PECA LABS, INC.
SUBSTANTIALLY EQUIVALENT
1
VASCUTEK LTD
SUBSTANTIALLY EQUIVALENT
1
W. L. GORE & ASSOCIATES INC.
SUBSTANTIALLY EQUIVALENT
1
W. L. GORE & ASSOCIATES, INC.
SUBSTANTIALLY EQUIVALENT
2
W.L. GORE & ASSOCIATES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
232
232
2020
169
169
2021
168
168
2022
155
155
2023
149
149
2024
131
131
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
141
141
Insufficient Information
107
107
Peeled/Delaminated
92
92
Obstruction of Flow
73
73
Material Split, Cut or Torn
64
64
Patient-Device Incompatibility
50
50
Material Integrity Problem
47
47
Complete Blockage
43
43
Microbial Contamination of Device
42
42
Material Puncture/Hole
41
41
Contamination
37
37
Manufacturing, Packaging or Shipping Problem
36
36
Product Quality Problem
35
35
Material Separation
32
32
Nonstandard Device
25
25
Patient Device Interaction Problem
24
24
Appropriate Term/Code Not Available
22
22
Use of Device Problem
20
20
Off-Label Use
20
20
Partial Blockage
20
20
Leak/Splash
18
18
Flaked
16
16
Material Perforation
14
14
Device Stenosis
14
14
Mechanical Problem
13
13
Fluid/Blood Leak
13
13
Material Deformation
12
12
Defective Device
9
9
Migration
9
9
Device Damaged Prior to Use
9
9
Infusion or Flow Problem
8
8
Shipping Damage or Problem
7
7
Detachment of Device or Device Component
6
6
Inaccurate Information
5
5
Device Handling Problem
5
5
Material Fragmentation
5
5
Material Rupture
5
5
Material Frayed
5
5
Device Contamination with Chemical or Other Material
4
4
Contamination /Decontamination Problem
4
4
Improper or Incorrect Procedure or Method
4
4
No Apparent Adverse Event
3
3
Human-Device Interface Problem
3
3
Deformation Due to Compressive Stress
3
3
Compatibility Problem
3
3
Material Twisted/Bent
3
3
Unraveled Material
3
3
Stretched
3
3
Device Markings/Labelling Problem
3
3
Difficult to Remove
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
189
189
Unspecified Infection
119
119
Thrombosis/Thrombus
99
99
Hemorrhage/Bleeding
83
83
Obstruction/Occlusion
55
55
Stenosis
45
45
No Consequences Or Impact To Patient
44
44
Bacterial Infection
44
44
Insufficient Information
42
42
Hematoma
37
37
Occlusion
34
34
Blood Loss
33
33
Pseudoaneurysm
29
29
Seroma
28
28
No Patient Involvement
27
27
Death
23
23
Thrombosis
22
22
No Known Impact Or Consequence To Patient
22
22
No Code Available
19
19
No Information
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Aneurysm
15
15
Ischemia
14
14
Vascular Dissection
13
13
Pain
10
10
Post Operative Wound Infection
10
10
Thrombus
10
10
Inflammation
9
9
Wound Dehiscence
8
8
Failure of Implant
7
7
Sepsis
6
6
Renal Failure
6
6
Failure to Anastomose
5
5
Swelling
5
5
Swelling/ Edema
4
4
Rupture
4
4
Perforation of Vessels
4
4
Heart Failure/Congestive Heart Failure
4
4
Fever
4
4
Ischemia Stroke
4
4
Abdominal Pain
4
4
Erosion
3
3
Purulent Discharge
3
3
Hypersensitivity/Allergic reaction
3
3
Foreign Body In Patient
3
3
Fistula
3
3
Myocardial Infarction
2
2
Embolism
2
2
Thromboembolism
2
2
Unspecified Vascular Problem
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
II
Jun-04-2024
2
Atrium Medical Corporation
II
Sep-29-2021
3
Maquet Cardiovascular, LLC
II
Mar-10-2023
4
Maquet Cardiovascular, LLC
II
Jun-23-2022
5
Vascutek, Ltd.
II
Sep-24-2021
6
W L Gore & Associates, Inc.
II
Aug-13-2021
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