TPLC - Total Product Life Cycle

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Device	prosthesis, tracheal, expandable
Regulation Description	Tracheal prosthesis.
Product Code	JCT
Regulation Number	878.3720
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
M.I. TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	138	138
Material Deformation	91	91
Adverse Event Without Identified Device or Use Problem	62	62
Break	49	49
Positioning Failure	43	43
Positioning Problem	42	42
Activation Failure	41	41
Use of Device Problem	26	26
Migration	25	25
Material Twisted/Bent	20	20
Failure to Advance	19	19
Appropriate Term/Code Not Available	19	19
Fracture	14	14
Defective Device	13	13
Leak/Splash	12	12
Difficult to Remove	12	12
Unraveled Material	12	12
Detachment of Device or Device Component	11	11
Material Separation	10	10
Device-Device Incompatibility	9	9
Difficult or Delayed Positioning	9	9
Difficult to Advance	8	8
Malposition of Device	7	7
Material Integrity Problem	7	7
Material Rupture	7	7
Device Stenosis	6	6
Insufficient Information	5	5
Device Dislodged or Dislocated	5	5
Mechanical Problem	5	5
Premature Activation	5	5
Obstruction of Flow	5	5
Premature Separation	4	4
Human-Device Interface Problem	4	4
Unsealed Device Packaging	3	3
Migration or Expulsion of Device	3	3
Difficult to Open or Close	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Deformation Due to Compressive Stress	3	3
Material Puncture/Hole	2	2
Off-Label Use	2	2
Complete Blockage	2	2
Entrapment of Device	2	2
Material Fragmentation	2	2
Packaging Problem	2	2
No Apparent Adverse Event	2	2
Separation Failure	2	2
Expiration Date Error	2	2
Separation Problem	2	2
Wrong Label	2	2
Stretched	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	287	287
No Consequences Or Impact To Patient	67	67
Obstruction/Occlusion	17	17
Hemorrhage/Bleeding	14	14
Insufficient Information	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Blood Loss	10	10
Death	9	9
Occlusion	8	8
Dyspnea	8	8
No Information	8	8
Thrombosis/Thrombus	6	6
Stenosis of the esophagus	6	6
Renal Failure	6	6
Restenosis	6	6
Aneurysm	5	5
Stenosis	5	5
Thrombosis	5	5
No Code Available	5	5
Perforation	5	5
Discomfort	4	4
Embolism	4	4
Ischemia	4	4
Hypoxia	4	4
No Known Impact Or Consequence To Patient	4	4
Unspecified Infection	4	4
Foreign Body Embolism	3	3
Respiratory Insufficiency	3	3
Pneumothorax	3	3
Device Embedded In Tissue or Plaque	3	3
Inflammation	3	3
Claudication	2	2
Pseudoaneurysm	2	2
Injury	2	2
No Patient Involvement	2	2
Thromboembolism	2	2
Foreign Body In Patient	2	2
Vascular Dissection	2	2
Hematoma	2	2
Cardiac Arrest	2	2
Calcium Deposits/Calcification	2	2
Erosion	2	2
Unspecified Kidney or Urinary Problem	2	2
Swelling/ Edema	1	1
Impotence	1	1
Low Blood Pressure/ Hypotension	1	1
Hypersensitivity/Allergic reaction	1	1
Granuloma	1	1
Pneumonia	1	1
Encephalopathy	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	I	May-18-2022