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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
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Activation, Positioning or Separation Problem
105
105
Adverse Event Without Identified Device or Use Problem
100
100
Positioning Problem
70
70
Activation Failure
54
54
Premature Activation
52
52
Break
47
47
Material Deformation
36
36
Insufficient Information
33
33
Difficult to Remove
32
32
Migration
25
25
Migration or Expulsion of Device
24
24
Delivery System Failure
21
21
Positioning Failure
16
16
Device Stenosis
12
12
Use of Device Problem
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
Difficult to Advance
6
6
Obstruction of Flow
6
6
Fracture
5
5
Material Twisted/Bent
5
5
Appropriate Term/Code Not Available
4
4
Kinked
4
4
Material Integrity Problem
4
4
Material Perforation
3
3
Structural Problem
3
3
Bent
3
3
Failure to Advance
3
3
Occlusion Within Device
3
3
Entrapment of Device
3
3
Mechanical Problem
3
3
Human-Device Interface Problem
3
3
Activation Problem
3
3
Unraveled Material
2
2
Partial Blockage
2
2
Deformation Due to Compressive Stress
2
2
Material Puncture/Hole
2
2
Defective Device
2
2
Air Leak
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult To Position
1
1
No Apparent Adverse Event
1
1
Material Separation
1
1
Material Erosion
1
1
No Display/Image
1
1
Unsealed Device Packaging
1
1
Device Appears to Trigger Rejection
1
1
Detachment Of Device Component
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
107
107
Perforation
92
92
No Known Impact Or Consequence To Patient
67
67
Obstruction/Occlusion
32
32
Bowel Perforation
31
31
Death
27
27
No Code Available
19
19
Hemorrhage/Bleeding
19
19
Abdominal Pain
17
17
Peritonitis
16
16
Pain
13
13
Insufficient Information
10
10
Erosion
9
9
Unspecified Infection
8
8
Occlusion
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Sepsis
6
6
Fistula
5
5
Pneumonia
5
5
Vomiting
5
5
Failure of Implant
4
4
Inflammation
4
4
Foreign Body In Patient
4
4
Pancreatitis
3
3
Ulcer
3
3
Discomfort
3
3
Fever
3
3
Cardiac Arrest
3
3
Restenosis
2
2
Internal Organ Perforation
2
2
Constipation
2
2
Stenosis
2
2
Laceration(s)
2
2
Diarrhea
2
2
Thrombosis/Thrombus
2
2
Burning Sensation
2
2
Blood Loss
2
2
Embolism/Embolus
2
2
No Information
2
2
Nausea
2
2
Migration
1
1
Post Traumatic Wound Infection
1
1
Edema
1
1
Hematoma
1
1
Alteration in Body Temperature
1
1
Aspiration/Inhalation
1
1
Septic Shock
1
1
Jaundice
1
1
Abdominal Cramps
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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