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TPLC
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show TPLC since
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Device
stent, colonic, metallic, expandable
Product Code
MQR
Regulation Number
878.3610
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
COOK IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
M.I. TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
M.I.TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
70
70
2015
72
72
2016
56
56
2017
49
49
2018
44
44
2019
42
42
2020
46
46
2021
56
56
2022
35
35
2023
38
38
2024
41
41
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
103
103
Adverse Event Without Identified Device or Use Problem
95
95
Positioning Problem
68
68
Activation Failure
53
53
Premature Activation
52
52
Break
45
45
Insufficient Information
33
33
Difficult to Remove
32
32
Material Deformation
31
31
Migration or Expulsion of Device
24
24
Migration
23
23
Delivery System Failure
21
21
Positioning Failure
14
14
Use of Device Problem
10
10
Device Stenosis
10
10
Improper or Incorrect Procedure or Method
9
9
Difficult or Delayed Positioning
9
9
Detachment of Device or Device Component
8
8
Off-Label Use
7
7
Obstruction of Flow
6
6
Fracture
5
5
Difficult to Advance
5
5
Material Integrity Problem
4
4
Material Twisted/Bent
4
4
Appropriate Term/Code Not Available
4
4
Kinked
4
4
Mechanical Problem
3
3
Entrapment of Device
3
3
Occlusion Within Device
3
3
Bent
3
3
Structural Problem
3
3
Material Perforation
3
3
Material Puncture/Hole
2
2
Failure to Advance
2
2
Unraveled Material
2
2
Deformation Due to Compressive Stress
2
2
Partial Blockage
2
2
Activation Problem
2
2
No Apparent Adverse Event
1
1
Human-Device Interface Problem
1
1
Detachment Of Device Component
1
1
Air Leak
1
1
No Display/Image
1
1
Unsealed Device Packaging
1
1
Difficult To Position
1
1
Material Erosion
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Defective Device
1
1
Device Appears to Trigger Rejection
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
207
207
No Clinical Signs, Symptoms or Conditions
95
95
Perforation
91
91
No Known Impact Or Consequence To Patient
67
67
Bowel Perforation
29
29
Obstruction/Occlusion
27
27
Death
27
27
No Code Available
19
19
Abdominal Pain
17
17
Hemorrhage/Bleeding
17
17
Peritonitis
16
16
Pain
13
13
Erosion
9
9
Insufficient Information
8
8
Occlusion
7
7
Unspecified Infection
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Vomiting
5
5
Sepsis
5
5
Fistula
5
5
Failure of Implant
4
4
Foreign Body In Patient
4
4
Ulcer
3
3
Discomfort
3
3
Fever
3
3
Inflammation
3
3
Laceration(s)
2
2
Internal Organ Perforation
2
2
Nausea
2
2
Burning Sensation
2
2
Pneumonia
2
2
Cardiac Arrest
2
2
Diarrhea
2
2
Stenosis
2
2
Blood Loss
2
2
No Information
2
2
Restenosis
2
2
Constipation
2
2
Thrombosis/Thrombus
2
2
Gastrointestinal Hemorrhage
1
1
Pancreatitis
1
1
Rectal Anastomotic Leakage
1
1
Alteration in Body Temperature
1
1
Fecal Incontinence
1
1
Urinary Incontinence
1
1
Abdominal Distention
1
1
Post Traumatic Wound Infection
1
1
Abdominal Cramps
1
1
Surgical procedure, additional
1
1
Migration
1
1
Disability
1
1
Pressure Sores
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Edema
1
1
Emotional Changes
1
1
Abscess
1
1
Aspiration/Inhalation
1
1
Bacterial Infection
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Low Blood Pressure/ Hypotension
1
1
Septic Shock
1
1
Shock
1
1
Skin Irritation
1
1
Tissue Damage
1
1
Myocardial Infarction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Aug-31-2010
2
SPS Sterilization, Inc
II
Sep-13-2018
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