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	62	62
Material Deformation	31	31
Positioning Problem	30	30
Activation Failure	29	29
Activation, Positioning or Separation Problem	25	25
Migration	25	25
Break	24	24
Premature Activation	24	24
Difficult to Remove	19	19
Positioning Failure	17	17
Device Stenosis	13	13
Use of Device Problem	11	11
Material Twisted/Bent	10	10
Migration or Expulsion of Device	9	9
Insufficient Information	8	8
Improper or Incorrect Procedure or Method	8	8
Difficult or Delayed Positioning	7	7
Off-Label Use	6	6
Material Integrity Problem	6	6
Difficult to Advance	5	5
Detachment of Device or Device Component	5	5
Obstruction of Flow	4	4
Entrapment of Device	3	3
Activation Problem	3	3
Structural Problem	3	3
Failure to Advance	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	120	120
Perforation	30	30
Obstruction/Occlusion	28	28
No Consequences Or Impact To Patient	27	27
Hemorrhage/Bleeding	21	21
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
No Code Available	5	5
Fistula	5	5
Pneumonia	5	5
Pancreatitis	3	3
Inflammation	3	3
Discomfort	3	3
Cardiac Arrest	3	3
Fever	3	3
Restenosis	2	2
Constipation	2	2
Unspecified Tissue Injury	2	2
Stenosis	2	2
Laceration(s)	2	2
Diarrhea	2	2
Thrombosis/Thrombus	2	2
Foreign Body In Patient	2	2
Peritonitis	2	2
Blood Loss	2	2
Embolism/Embolus	2	2
No Information	2	2
Nausea	2	2
Burning Sensation	1	1
Post Traumatic Wound Infection	1	1
Edema	1	1
Alteration in Body Temperature	1	1
Septic Shock	1	1
Jaundice	1	1
Hematoma	1	1
Aspiration/Inhalation	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Abscess	1	1
Abdominal Cramps	1	1
Fecal Incontinence	1	1
Shock	1	1