TPLC - Total Product Life Cycle

show TPLC since

Device	stent, colonic, metallic, expandable
Product Code	MQR
Regulation Number	878.3610
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
COOK IRELAND LTD
	SUBSTANTIALLY EQUIVALENT	1
M.I. TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
M.I.TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	103	103
Adverse Event Without Identified Device or Use Problem	95	95
Positioning Problem	68	68
Activation Failure	53	53
Premature Activation	52	52
Break	45	45
Insufficient Information	33	33
Difficult to Remove	32	32
Material Deformation	31	31
Migration or Expulsion of Device	24	24
Migration	23	23
Delivery System Failure	21	21
Positioning Failure	14	14
Device Stenosis	10	10
Use of Device Problem	10	10
Difficult or Delayed Positioning	9	9
Improper or Incorrect Procedure or Method	9	9
Detachment of Device or Device Component	8	8
Off-Label Use	7	7
Obstruction of Flow	6	6
Fracture	5	5
Difficult to Advance	5	5
Kinked	4	4
Material Twisted/Bent	4	4
Material Integrity Problem	4	4
Appropriate Term/Code Not Available	4	4
Structural Problem	3	3
Occlusion Within Device	3	3
Bent	3	3
Entrapment of Device	3	3
Mechanical Problem	3	3
Material Perforation	3	3
Partial Blockage	2	2
Failure to Advance	2	2
Unraveled Material	2	2
Deformation Due to Compressive Stress	2	2
Material Puncture/Hole	2	2
Activation Problem	2	2
No Display/Image	1	1
No Apparent Adverse Event	1	1
Device Appears to Trigger Rejection	1	1
Human-Device Interface Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Detachment Of Device Component	1	1
Unsealed Device Packaging	1	1
Material Separation	1	1
Air Leak	1	1
Defective Device	1	1
Difficult To Position	1	1
Material Erosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	207	207
No Clinical Signs, Symptoms or Conditions	95	95
Perforation	91	91
No Known Impact Or Consequence To Patient	67	67
Bowel Perforation	29	29
Obstruction/Occlusion	27	27
Death	27	27
No Code Available	19	19
Abdominal Pain	17	17
Hemorrhage/Bleeding	17	17
Peritonitis	16	16
Pain	13	13
Erosion	9	9
Insufficient Information	8	8
Occlusion	7	7
Unspecified Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Vomiting	5	5
Sepsis	5	5
Fistula	5	5
Failure of Implant	4	4
Foreign Body In Patient	4	4
Ulcer	3	3
Discomfort	3	3
Fever	3	3
Inflammation	3	3
Laceration(s)	2	2
Internal Organ Perforation	2	2
Nausea	2	2
Burning Sensation	2	2
Pneumonia	2	2
Cardiac Arrest	2	2
Diarrhea	2	2
Stenosis	2	2
Blood Loss	2	2
No Information	2	2
Restenosis	2	2
Constipation	2	2
Thrombosis/Thrombus	2	2
Gastrointestinal Hemorrhage	1	1
Pancreatitis	1	1
Rectal Anastomotic Leakage	1	1
Alteration in Body Temperature	1	1
Fecal Incontinence	1	1
Urinary Incontinence	1	1
Abdominal Distention	1	1
Post Traumatic Wound Infection	1	1
Abdominal Cramps	1	1
Surgical procedure, additional	1	1
Migration	1	1
Disability	1	1
Pressure Sores	1	1
Disseminated Intravascular Coagulation (DIC)	1	1
Edema	1	1
Emotional Changes	1	1
Abscess	1	1
Aspiration/Inhalation	1	1
Bacterial Infection	1	1
Hematoma	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Septic Shock	1	1
Shock	1	1
Skin Irritation	1	1
Tissue Damage	1	1
Myocardial Infarction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Aug-31-2010
2	SPS Sterilization, Inc	II	Sep-13-2018