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	60	60
Material Deformation	35	35
Activation Failure	31	31
Positioning Problem	30	30
Migration	25	25
Activation, Positioning or Separation Problem	24	24
Break	23	23
Positioning Failure	20	20
Difficult to Remove	18	18
Premature Activation	17	17
Material Twisted/Bent	13	13
Device Stenosis	12	12
Use of Device Problem	11	11
Material Integrity Problem	8	8
Improper or Incorrect Procedure or Method	8	8
Migration or Expulsion of Device	7	7
Difficult or Delayed Positioning	7	7
Difficult to Advance	6	6
Off-Label Use	5	5
Insufficient Information	5	5
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
Human-Device Interface Problem	3	3
Mechanical Problem	2	2
Unsealed Device Packaging	2	2
Structural Problem	2	2
No Display/Image	1	1
Material Puncture/Hole	1	1
Defective Device	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Dent in Material	1	1
Material Perforation	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Device Appears to Trigger Rejection	1	3
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	145	145
Obstruction/Occlusion	27	29
Perforation	25	25
Bowel Perforation	19	21
Hemorrhage/Bleeding	17	17
Insufficient Information	9	9
Occlusion	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Erosion	5	7
Pneumonia	5	5
Pain	5	7
Abdominal Pain	4	4
Unspecified Infection	4	6
No Consequences Or Impact To Patient	4	4
Pancreatitis	3	3
Fistula	3	5
Sepsis	3	3
Inflammation	3	3
Vomiting	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
No Known Impact Or Consequence To Patient	2	2
Peritonitis	2	2
Cardiac Arrest	2	2
Embolism/Embolus	2	2
Fecal Incontinence	2	2
No Information	2	2
Nausea	2	2
Fever	1	1
Burning Sensation	1	3
Post Traumatic Wound Infection	1	1
Septic Shock	1	1
Jaundice	1	1
Discomfort	1	1
Alteration in Body Temperature	1	1
Incontinence	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Blood Loss	1	1
Aspiration/Inhalation	1	1
Ulcer	1	1
Bacterial Infection	1	1
Rectal Anastomotic Leakage	1	1
Urinary Incontinence	1	3
Failure of Implant	1	3
Emotional Changes	1	3