TPLC - Total Product Life Cycle

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Device	stent, metallic, expandable, duodenal
Regulation Description	Esophageal prosthesis.
Product Code	MUM
Regulation Number	878.3610
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	59	59
Adverse Event Without Identified Device or Use Problem	54	56
Migration	43	43
Fracture	39	39
Activation Failure	23	24
Material Deformation	20	20
Activation, Positioning or Separation Problem	16	16
Positioning Problem	14	14
Positioning Failure	14	14
Premature Activation	13	13
Improper or Incorrect Procedure or Method	11	11
Material Twisted/Bent	9	9
Partial Blockage	8	8
Difficult to Remove	8	8
Migration or Expulsion of Device	7	7
Device Stenosis	6	7
Use of Device Problem	6	6
Off-Label Use	5	5
Insufficient Information	5	5
Detachment of Device or Device Component	4	4
Complete Blockage	4	6
Physical Resistance/Sticking	4	4
Defective Device	3	3
Device Damaged Prior to Use	3	3
Failure to Advance	3	3
Appropriate Term/Code Not Available	3	3
Material Integrity Problem	2	2
Material Perforation	2	2
Structural Problem	2	2
Unsealed Device Packaging	2	2
Difficult or Delayed Positioning	2	2
Difficult to Advance	2	2
Material Separation	2	2
Collapse	2	3
Activation Problem	2	2
Deformation Due to Compressive Stress	2	2
Entrapment of Device	2	2
Obstruction of Flow	1	1
Unclear Information	1	1
Packaging Problem	1	1
Poor Visibility	1	1
Retraction Problem	1	1
No Apparent Adverse Event	1	1
Human-Device Interface Problem	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	117	117
Obstruction/Occlusion	41	43
Hemorrhage/Bleeding	15	17
Insufficient Information	15	17
No Known Impact Or Consequence To Patient	13	13
Perforation	13	13
Erosion	12	14
Vomiting	12	13
No Consequences Or Impact To Patient	10	10
Stenosis	10	10
Occlusion	8	8
Gastrointestinal Hemorrhage	7	7
No Information	6	6
Pneumonia	5	5
Abdominal Pain	5	5
Inflammation	4	4
Fever	4	5
Nausea	4	4
Bowel Perforation	3	3
Aspiration/Inhalation	3	3
Foreign Body In Patient	3	3
Pancreatitis	3	3
Abdominal Distention	2	2
No Code Available	2	2
Sepsis	2	3
Thrombosis/Thrombus	2	4
Pain	2	2
Feeding Problem	2	2
Unspecified Infection	2	2
Constipation	2	2
Restenosis	2	2
Hematoma	1	2
Necrosis	1	1
Anemia	1	1
Blood Loss	1	1
Cardiac Arrest	1	2
Discomfort	1	1
Failure of Implant	1	1
Abscess	1	1
Shock	1	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	2
Ulcer	1	1
Dysphasia	1	1
Respiratory Insufficiency	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	2
Aspiration Pneumonitis	1	1