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TPLC
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Device
prosthesis, tracheal, expandable
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
2019
106
106
2020
120
120
2021
106
106
2022
61
61
2023
110
110
2024
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
115
115
Material Deformation
92
92
Adverse Event Without Identified Device or Use Problem
63
63
Break
59
59
Positioning Problem
48
48
Activation Failure
42
42
Positioning Failure
40
40
Migration
27
27
Use of Device Problem
24
24
Appropriate Term/Code Not Available
19
19
Detachment of Device or Device Component
19
19
Failure to Advance
18
18
Leak/Splash
16
16
Difficult to Remove
16
16
Defective Device
15
15
Unraveled Material
14
14
Material Twisted/Bent
14
14
Fracture
14
14
Material Separation
10
10
Obstruction of Flow
9
9
Material Rupture
9
9
Device-Device Incompatibility
9
9
Material Integrity Problem
9
9
Device Dislodged or Dislocated
8
8
Premature Activation
8
8
Difficult or Delayed Positioning
7
7
Difficult to Advance
7
7
Malposition of Device
7
7
Device Stenosis
6
6
Mechanical Problem
6
6
Insufficient Information
5
5
Human-Device Interface Problem
5
5
Expiration Date Error
4
4
Premature Separation
4
4
Migration or Expulsion of Device
4
4
Burst Container or Vessel
4
4
Entrapment of Device
4
4
Complete Blockage
3
3
Loose or Intermittent Connection
3
3
Deformation Due to Compressive Stress
3
3
Device Misassembled During Manufacturing /Shipping
3
3
Separation Failure
2
2
Separation Problem
2
2
No Apparent Adverse Event
2
2
Packaging Problem
2
2
Off-Label Use
2
2
Material Puncture/Hole
2
2
Structural Problem
2
2
Device Slipped
2
2
Contamination
2
2
Material Fragmentation
2
2
Inflation Problem
2
2
Difficult to Insert
1
1
Fluid/Blood Leak
1
1
Disconnection
1
1
Deflation Problem
1
1
Partial Blockage
1
1
Collapse
1
1
Stretched
1
1
Failure to Align
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Component Missing
1
1
Unsealed Device Packaging
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Unclear Information
1
1
Failure to Fire
1
1
Component or Accessory Incompatibility
1
1
Device Markings/Labelling Problem
1
1
Infusion or Flow Problem
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
221
221
No Consequences Or Impact To Patient
113
113
No Information
22
22
Obstruction/Occlusion
18
18
No Known Impact Or Consequence To Patient
18
18
Blood Loss
15
15
Hemorrhage/Bleeding
13
13
Insufficient Information
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Code Available
11
11
Death
11
11
Occlusion
11
11
Dyspnea
8
8
No Patient Involvement
8
8
Stenosis
8
8
Thrombosis/Thrombus
6
6
Stenosis of the esophagus
6
6
Restenosis
6
6
Unspecified Infection
6
6
Inflammation
6
6
Thrombosis
6
6
Renal Failure
5
5
Ischemia
5
5
Aneurysm
5
5
Hypoxia
5
5
Embolism
4
4
Pneumothorax
4
4
Device Embedded In Tissue or Plaque
4
4
Discomfort
4
4
Vascular Dissection
3
3
Foreign Body In Patient
3
3
Respiratory Insufficiency
3
3
Foreign Body Embolism
3
3
Perforation
3
3
Hematoma
3
3
Calcium Deposits/Calcification
2
2
Erosion
2
2
Airway Obstruction
2
2
Pneumonia
2
2
Respiratory Distress
2
2
Heart Failure
2
2
Unspecified Kidney or Urinary Problem
2
2
Claudication
2
2
Thromboembolism
2
2
Pseudoaneurysm
2
2
Injury
2
2
Disability
1
1
Laceration(s) of Esophagus
1
1
Respiratory Tract Infection
1
1
Ulcer
1
1
Respiratory Failure
1
1
Ischemic Heart Disease
1
1
Cough
1
1
Swelling/ Edema
1
1
Rupture
1
1
Peritonitis
1
1
Shock
1
1
Thrombus
1
1
Perforation of Vessels
1
1
Pulmonary Edema
1
1
Pain
1
1
Anemia
1
1
Bradycardia
1
1
Encephalopathy
1
1
Fistula
1
1
Granuloma
1
1
Abrasion
1
1
Hemoptysis
1
1
Impotence
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Atrium Medical Corporation
I
May-18-2022
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