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	66	66
Material Deformation	37	37
Activation Failure	36	36
Positioning Problem	30	30
Activation, Positioning or Separation Problem	29	29
Break	27	27
Migration	27	27
Premature Activation	24	24
Difficult to Remove	23	23
Positioning Failure	19	19
Material Twisted/Bent	13	13
Device Stenosis	12	12
Use of Device Problem	12	12
Migration or Expulsion of Device	9	9
Improper or Incorrect Procedure or Method	9	9
Insufficient Information	8	8
Material Integrity Problem	8	8
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
Mechanical Problem	3	3
Activation Problem	3	3
Structural Problem	3	3
Human-Device Interface Problem	3	3
Deformation Due to Compressive Stress	3	3
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	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	135	135
Perforation	30	30
Obstruction/Occlusion	28	30
No Consequences Or Impact To Patient	27	27
Hemorrhage/Bleeding	20	20
Bowel Perforation	20	22
No Known Impact Or Consequence To Patient	12	12
Insufficient Information	9	9
Abdominal Pain	7	7
Occlusion	7	7
Unspecified Infection	6	8
Pain	6	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Fistula	5	7
Sepsis	5	5
No Code Available	5	5
Erosion	5	7
Pneumonia	5	5
Vomiting	5	5
Discomfort	4	4
Pancreatitis	3	3
Inflammation	3	3
Foreign Body In Patient	3	3
Restenosis	2	2
Constipation	2	2
Unspecified Tissue Injury	2	2
Stenosis	2	2
Laceration(s)	2	2
Diarrhea	2	2
Fever	2	2
Peritonitis	2	2
Cardiac Arrest	2	2
Blood Loss	2	2
Embolism/Embolus	2	2
Fecal Incontinence	2	2
No Information	2	2
Nausea	2	2
Post Traumatic Wound Infection	1	1
Burning Sensation	1	3
Incontinence	1	1
Septic Shock	1	1
Jaundice	1	1
Alteration in Body Temperature	1	1
Edema	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Abdominal Cramps	1	1
Abscess	1	1
Aspiration/Inhalation	1	1
Rectal Anastomotic Leakage	1	1
Ulcer	1	1