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TPLC
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show TPLC since
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2024
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Device
stent, metallic, expandable, duodenal
Product Code
MUM
Regulation Number
878.3610
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
TAEWOONG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
43
43
2015
51
51
2016
41
41
2017
85
85
2018
49
49
2019
35
35
2020
32
32
2021
70
70
2022
28
28
2023
52
52
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
97
97
Activation, Positioning or Separation Problem
81
81
Fracture
80
80
Adverse Event Without Identified Device or Use Problem
70
70
Activation Failure
40
40
Migration
39
39
Positioning Problem
37
37
Migration or Expulsion of Device
37
37
Premature Activation
26
26
Delivery System Failure
22
22
Material Deformation
22
22
Partial Blockage
19
19
Positioning Failure
16
16
Difficult to Remove
15
15
Insufficient Information
15
15
Improper or Incorrect Procedure or Method
11
11
Appropriate Term/Code Not Available
10
10
Detachment of Device or Device Component
7
7
Difficult or Delayed Positioning
7
7
Off-Label Use
6
6
Kinked
5
5
Use of Device Problem
5
5
Difficult to Advance
4
4
Complete Blockage
4
4
Device Stenosis
4
4
Material Twisted/Bent
3
3
Occlusion Within Device
3
3
Device Damaged Prior to Use
3
3
Obstruction of Flow
3
3
Defective Device
3
3
Failure to Advance
2
2
Unsealed Device Packaging
2
2
Material Separation
2
2
Collapse
2
2
Entrapment of Device
2
2
Activation Problem
2
2
Premature Separation
1
1
Unclear Information
1
1
Physical Resistance/Sticking
1
1
Material Integrity Problem
1
1
Packaging Problem
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Tip breakage
1
1
Unraveled Material
1
1
Retraction Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Operates Differently Than Expected
1
1
Device Packaging Compromised
1
1
Delivery System Issue, No Description
1
1
Deformation Due to Compressive Stress
1
1
Structural Problem
1
1
Material Perforation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
141
141
No Clinical Signs, Symptoms or Conditions
81
81
No Known Impact Or Consequence To Patient
79
79
Perforation
49
49
Obstruction/Occlusion
46
46
Vomiting
28
28
Death
20
20
Hemorrhage/Bleeding
18
18
Stenosis
14
14
Erosion
13
13
Abdominal Pain
12
12
Inflammation
12
12
Occlusion
11
11
No Code Available
11
11
Insufficient Information
10
10
Foreign Body In Patient
7
7
Pneumonia
7
7
Aspiration/Inhalation
6
6
No Information
6
6
Gastrointestinal Hemorrhage
6
6
Unspecified Infection
5
5
Pain
4
4
Nausea
4
4
Peritonitis
4
4
Bowel Perforation
3
3
Fever
3
3
Hematoma
2
2
Anemia
2
2
Feeding Problem
2
2
Cardiac Arrest
2
2
Necrosis
2
2
Laceration(s)
2
2
Reocclusion
2
2
Migration
2
2
Constipation
2
2
Thrombosis/Thrombus
2
2
Discomfort
2
2
Abdominal Distention
2
2
Pancreatitis
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Weight Changes
1
1
No Patient Involvement
1
1
Surgical procedure, additional
1
1
Blood Loss
1
1
Foreign body, removal of
1
1
Ulcer
1
1
Aspiration Pneumonitis
1
1
Device Embedded In Tissue or Plaque
1
1
Dysphasia
1
1
Sepsis
1
1
Shock
1
1
Dysphagia/ Odynophagia
1
1
Bacterial Infection
1
1
Air Embolism
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Failure of Implant
1
1
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