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
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	133	133
Material Deformation	60	60
Adverse Event Without Identified Device or Use Problem	51	51
Break	41	41
Positioning Problem	38	38
Activation Failure	36	36
Positioning Failure	30	30
Use of Device Problem	28	28
Material Twisted/Bent	21	21
Migration	20	21
Failure to Advance	15	15
Defective Device	14	14
Fracture	13	13
Appropriate Term/Code Not Available	12	12
Difficult to Remove	12	12
Detachment of Device or Device Component	11	11
Unraveled Material	9	9
Material Separation	9	9
Device-Device Incompatibility	8	8
Material Integrity Problem	7	7
Difficult or Delayed Positioning	7	7
Material Rupture	7	7
Leak/Splash	6	6
Premature Activation	6	6
Malposition of Device	6	6
Device Stenosis	6	6
Difficult to Advance	6	6
Mechanical Problem	5	5
Difficult to Open or Close	5	5
Premature Separation	4	4
Human-Device Interface Problem	4	4
Insufficient Information	4	4
Unsealed Device Packaging	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Fluid/Blood Leak	2	2
Deformation Due to Compressive Stress	2	2
Device Dislodged or Dislocated	2	2
No Apparent Adverse Event	2	2
Packaging Problem	2	2
Patient Device Interaction Problem	2	2
Wrong Label	2	2
Separation Failure	2	2
Material Puncture/Hole	2	2
Off-Label Use	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Inflation Problem	1	1
Infusion or Flow Problem	1	1
Partial Blockage	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	311	311
Obstruction/Occlusion	16	16
Hemorrhage/Bleeding	13	13
Insufficient Information	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Restenosis	6	6
Thrombosis/Thrombus	6	6
Stenosis of the esophagus	6	6
Aneurysm	5	5
Dyspnea	5	5
Death	4	4
Erosion	4	4
Hypoxia	4	4
Stenosis	4	4
Respiratory Insufficiency	3	3
No Consequences Or Impact To Patient	3	3
Inflammation	3	3
Foreign Body In Patient	3	3
Discomfort	3	3
Foreign Body Embolism	3	3
Pseudoaneurysm	2	2
Calcium Deposits/Calcification	2	2
Renal Failure	2	2
Unspecified Kidney or Urinary Problem	2	2
Cardiac Arrest	2	2
Blood Loss	2	2
Perforation	2	2
Hematoma	2	2
Ischemia	2	2
Occlusion	2	2
Unspecified Infection	2	2
Injury	1	1
Pneumonia	1	2
Bradycardia	1	1
Laceration(s) of Esophagus	1	1
Anemia	1	1
Rupture	1	1
Cough	1	1
Swelling/ Edema	1	1
Shock	1	1
Perforation of Vessels	1	1
Embolism	1	1
Ulcer	1	1
Ischemic Heart Disease	1	1
Pneumothorax	1	1
Respiratory Failure	1	1
Granuloma	1	1
Device Embedded In Tissue or Plaque	1	1

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