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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	62	62
Material Deformation	37	37
Activation Failure	32	32
Positioning Problem	31	31
Migration	25	25
Break	24	24
Activation, Positioning or Separation Problem	24	24
Positioning Failure	20	20
Premature Activation	18	18
Difficult to Remove	18	18
Material Twisted/Bent	14	14
Device Stenosis	12	12
Use of Device Problem	11	11
Material Integrity Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Difficult or Delayed Positioning	7	7
Migration or Expulsion of Device	7	7
Difficult to Advance	6	6
Detachment of Device or Device Component	5	5
Insufficient Device Problem Information	5	5
Off-Label Use	5	5
Obstruction of Flow	4	4
Failure to Advance	4	4
Entrapment of Device	3	3
Human-Device Interface Problem	3	3
Activation Problem	3	3
Structural Problem	2	2
Unsealed Device Packaging	2	2
No Display/Image	1	1
Fracture	1	1
Deformation Due to Compressive Stress	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Unraveled Material	1	1
Material Perforation	1	1
Dent in Material	1	1
Defective Device	1	1
Malposition of Device	1	1
Mechanical Problem	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	150	150
Obstruction/Occlusion	27	29
Perforation	26	26
Bowel Perforation	19	21
Hemorrhage/Blood Loss/Bleeding	17	17
Insufficient Information	9	9
Cholangitis	7	7
Occlusion	6	6
Pain	6	8
Erosion	5	7
Pneumonia	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Abdominal Pain	4	4
Unspecified Infection	4	6
No Consequences Or Impact To Patient	4	4
Pancreatitis	3	3
Inflammation	3	3
Fistula	3	5
Sepsis	3	3
Vomiting	3	3
Foreign Body In Patient	3	3
No Information	2	2
Stenosis	2	2
Cardiac Arrest	2	2
Embolism/Embolus	2	2
Peritonitis	2	2
Fecal Incontinence	2	2
Diarrhea	2	2
Constipation	2	2
Laceration(s)	2	2
Unspecified Tissue Injury	2	2
No Known Impact Or Consequence To Patient	2	2
Restenosis	2	2
Nausea	2	2
Bacterial Infection	1	1
Burning Sensation	1	3
Fever	1	1
Urinary Incontinence	1	3
Discomfort	1	1
Rectal Anastomotic Leakage	1	1
Wound Infection	1	1
Jaundice	1	1
Blood Loss	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Septic Shock	1	1
Ulcer	1	1
Aspiration/Inhalation	1	1
Incontinence	1	1
Emotional Changes	1	3
Alteration in Body Temperature	1	1