TPLC - Total Product Life Cycle

show TPLC since

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
Adverse Event Without Identified Device or Use Problem	52	54
Break	47	47
Migration	38	38
Fracture	30	30
Activation Failure	19	20
Material Deformation	19	19
Positioning Failure	14	14
Premature Activation	12	12
Positioning Problem	10	10
Improper or Incorrect Procedure or Method	9	9
Material Twisted/Bent	9	9
Activation, Positioning or Separation Problem	7	7
Partial Blockage	7	7
Device Stenosis	6	7
Difficult to Remove	6	6
Use of Device Problem	6	6
Insufficient Information	5	5
Migration or Expulsion of Device	4	4
Off-Label Use	4	4
Complete Blockage	4	6
Detachment of Device or Device Component	4	4
Appropriate Term/Code Not Available	3	3
Failure to Advance	3	3
Defective Device	3	3
Device Damaged Prior to Use	3	3
Physical Resistance/Sticking	3	3
Structural Problem	2	2
Material Perforation	2	2
Material Integrity Problem	2	2
Material Separation	2	2
Unsealed Device Packaging	2	2
Difficult to Advance	2	2
Collapse	2	3
Premature Separation	2	2
Difficult or Delayed Positioning	1	1
Obstruction of Flow	1	1
Packaging Problem	1	1
Poor Visibility	1	1
Retraction Problem	1	1
No Apparent Adverse Event	1	1
Activation Problem	1	1
Human-Device Interface Problem	1	1
Deformation Due to Compressive Stress	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	113	113
Obstruction/Occlusion	37	39
Insufficient Information	15	17
Hemorrhage/Bleeding	14	16
Perforation	13	13
Erosion	11	13
Vomiting	11	12
Stenosis	9	9
Gastrointestinal Hemorrhage	6	6
No Information	6	6
Abdominal Pain	5	5
Pneumonia	5	5
Nausea	4	4
Inflammation	4	4
Fever	4	5
Pancreatitis	3	3
Occlusion	3	3
Bowel Perforation	3	3
Aspiration/Inhalation	3	3
Restenosis	2	2
Constipation	2	2
No Consequences Or Impact To Patient	2	2
Feeding Problem	2	2
Pain	2	2
Thrombosis/Thrombus	2	4
Foreign Body In Patient	2	2
No Known Impact Or Consequence To Patient	2	2
Cardiac Arrest	2	3
Abdominal Distention	2	2
Sepsis	2	3
Unspecified Infection	2	2
Discomfort	1	1
Blood Loss	1	1
Abscess	1	1
Anemia	1	1
Shock	1	2
Hematoma	1	2
Ulcer	1	1
Necrosis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	2
Dysphasia	1	1
Respiratory Insufficiency	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	2
Aspiration Pneumonitis	1	1