TPLC - Total Product Life Cycle

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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

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