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TPLC
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Device
prosthesis, tracheal, expandable
Regulation Description
Tracheal prosthesis.
Product Code
JCT
Regulation Number
878.3720
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
M.I. TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2020
120
120
2021
106
106
2022
61
61
2023
110
110
2024
77
77
2025
24
24
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
138
138
Material Deformation
91
91
Adverse Event Without Identified Device or Use Problem
62
62
Break
49
49
Positioning Failure
43
43
Positioning Problem
42
42
Activation Failure
41
41
Use of Device Problem
26
26
Migration
25
25
Material Twisted/Bent
20
20
Failure to Advance
19
19
Appropriate Term/Code Not Available
19
19
Fracture
14
14
Defective Device
13
13
Leak/Splash
12
12
Difficult to Remove
12
12
Unraveled Material
12
12
Detachment of Device or Device Component
11
11
Material Separation
10
10
Device-Device Incompatibility
9
9
Difficult or Delayed Positioning
9
9
Difficult to Advance
8
8
Malposition of Device
7
7
Material Integrity Problem
7
7
Material Rupture
7
7
Device Stenosis
6
6
Insufficient Information
5
5
Device Dislodged or Dislocated
5
5
Mechanical Problem
5
5
Premature Activation
5
5
Obstruction of Flow
5
5
Premature Separation
4
4
Human-Device Interface Problem
4
4
Unsealed Device Packaging
3
3
Migration or Expulsion of Device
3
3
Difficult to Open or Close
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Deformation Due to Compressive Stress
3
3
Material Puncture/Hole
2
2
Off-Label Use
2
2
Complete Blockage
2
2
Entrapment of Device
2
2
Material Fragmentation
2
2
Packaging Problem
2
2
No Apparent Adverse Event
2
2
Separation Failure
2
2
Expiration Date Error
2
2
Separation Problem
2
2
Wrong Label
2
2
Stretched
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
287
287
No Consequences Or Impact To Patient
67
67
Obstruction/Occlusion
17
17
Hemorrhage/Bleeding
14
14
Insufficient Information
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Blood Loss
10
10
Death
9
9
Occlusion
8
8
Dyspnea
8
8
No Information
8
8
Thrombosis/Thrombus
6
6
Stenosis of the esophagus
6
6
Renal Failure
6
6
Restenosis
6
6
Aneurysm
5
5
Stenosis
5
5
Thrombosis
5
5
No Code Available
5
5
Perforation
5
5
Discomfort
4
4
Embolism
4
4
Ischemia
4
4
Hypoxia
4
4
No Known Impact Or Consequence To Patient
4
4
Unspecified Infection
4
4
Foreign Body Embolism
3
3
Respiratory Insufficiency
3
3
Pneumothorax
3
3
Device Embedded In Tissue or Plaque
3
3
Inflammation
3
3
Claudication
2
2
Pseudoaneurysm
2
2
Injury
2
2
No Patient Involvement
2
2
Thromboembolism
2
2
Foreign Body In Patient
2
2
Vascular Dissection
2
2
Hematoma
2
2
Cardiac Arrest
2
2
Calcium Deposits/Calcification
2
2
Erosion
2
2
Unspecified Kidney or Urinary Problem
2
2
Swelling/ Edema
1
1
Impotence
1
1
Low Blood Pressure/ Hypotension
1
1
Hypersensitivity/Allergic reaction
1
1
Granuloma
1
1
Pneumonia
1
1
Encephalopathy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
I
May-18-2022
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