Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
stent, colonic, metallic, expandable
Regulation Description
Esophageal prosthesis.
Product Code
MQR
Regulation Number
878.3610
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2020
46
46
2021
56
56
2022
35
35
2023
38
38
2024
72
72
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
64
64
Material Deformation
33
33
Positioning Problem
30
30
Activation Failure
29
29
Activation, Positioning or Separation Problem
28
28
Migration
26
26
Break
24
24
Premature Activation
24
24
Difficult to Remove
20
20
Positioning Failure
18
18
Device Stenosis
13
13
Use of Device Problem
12
12
Material Twisted/Bent
10
10
Migration or Expulsion of Device
9
9
Insufficient Information
8
8
Improper or Incorrect Procedure or Method
8
8
Material Integrity Problem
7
7
Difficult or Delayed Positioning
7
7
Off-Label Use
6
6
Difficult to Advance
6
6
Detachment of Device or Device Component
5
5
Obstruction of Flow
4
4
Failure to Advance
4
4
Entrapment of Device
3
3
Activation Problem
3
3
Structural Problem
3
3
Human-Device Interface Problem
3
3
Deformation Due to Compressive Stress
3
3
Mechanical Problem
2
2
Material Puncture/Hole
2
2
Appropriate Term/Code Not Available
2
2
No Display/Image
1
1
Unsealed Device Packaging
1
1
Defective Device
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Dent in Material
1
1
Material Perforation
1
1
Device Appears to Trigger Rejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
124
124
Perforation
30
30
Obstruction/Occlusion
28
28
No Consequences Or Impact To Patient
27
27
Hemorrhage/Bleeding
22
22
Bowel Perforation
20
20
No Known Impact Or Consequence To Patient
12
12
Insufficient Information
10
10
Abdominal Pain
7
7
Erosion
7
7
Occlusion
7
7
Unspecified Infection
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Sepsis
6
6
Pain
6
6
Vomiting
6
6
Fistula
5
5
No Code Available
5
5
Pneumonia
5
5
Discomfort
3
3
Fever
3
3
Cardiac Arrest
3
3
Inflammation
3
3
Pancreatitis
3
3
Embolism/Embolus
2
2
Blood Loss
2
2
Peritonitis
2
2
Foreign Body In Patient
2
2
Thrombosis/Thrombus
2
2
Diarrhea
2
2
No Information
2
2
Nausea
2
2
Laceration(s)
2
2
Stenosis
2
2
Unspecified Tissue Injury
2
2
Constipation
2
2
Restenosis
2
2
Edema
1
1
Hematoma
1
1
Post Traumatic Wound Infection
1
1
Aspiration/Inhalation
1
1
Incontinence
1
1
Abdominal Cramps
1
1
Burning Sensation
1
1
Fecal Incontinence
1
1
Rectal Anastomotic Leakage
1
1
Alteration in Body Temperature
1
1
Septic Shock
1
1
Jaundice
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
-
-