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	147	147
Material Deformation	92	92
Adverse Event Without Identified Device or Use Problem	65	65
Break	51	51
Positioning Failure	46	46
Activation Failure	44	44
Positioning Problem	42	42
Use of Device Problem	27	27
Migration	25	25
Material Twisted/Bent	24	24
Appropriate Term/Code Not Available	19	19
Failure to Advance	19	19
Fracture	14	14
Defective Device	14	14
Detachment of Device or Device Component	13	13
Leak/Splash	12	12
Unraveled Material	12	12
Difficult to Remove	12	12
Material Separation	10	10
Device-Device Incompatibility	9	9
Difficult or Delayed Positioning	9	9
Difficult to Advance	8	8
Material Integrity Problem	8	8
Malposition of Device	7	7
Material Rupture	7	7
Premature Activation	6	6
Device Stenosis	6	6
Difficult to Open or Close	5	5
Device Dislodged or Dislocated	5	5
Obstruction of Flow	5	5
Insufficient Information	5	5
Mechanical Problem	5	5
Human-Device Interface Problem	4	4
Premature Separation	4	4
Device Misassembled During Manufacturing /Shipping	3	3
Unsealed Device Packaging	3	3
Migration or Expulsion of Device	3	3
Deformation Due to Compressive Stress	3	3
Patient Device Interaction Problem	2	2
Material Fragmentation	2	2
Expiration Date Error	2	2
Wrong Label	2	2
Separation Failure	2	2
Material Puncture/Hole	2	2
Packaging Problem	2	2
Complete Blockage	2	2
No Apparent Adverse Event	2	2
Off-Label Use	2	2
Entrapment of Device	2	2
Separation Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	305	305
No Consequences Or Impact To Patient	67	67
Obstruction/Occlusion	17	17
Hemorrhage/Bleeding	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Insufficient Information	12	12
Blood Loss	10	10
Death	9	9
Occlusion	8	8
No Information	8	8
Dyspnea	8	8
Restenosis	6	6
Renal Failure	6	6
Thrombosis/Thrombus	6	6
Stenosis of the esophagus	6	6
No Code Available	5	5
Perforation	5	5
Aneurysm	5	5
Stenosis	5	5
Thrombosis	5	5
Unspecified Infection	4	4
Erosion	4	4
Ischemia	4	4
Pseudoaneurysm	4	4
Hypoxia	4	4
Embolism	4	4
No Known Impact Or Consequence To Patient	4	4
Discomfort	4	4
Device Embedded In Tissue or Plaque	3	3
Respiratory Insufficiency	3	3
Foreign Body Embolism	3	3
Inflammation	3	3
Pneumothorax	3	3
No Patient Involvement	2	2
Foreign Body In Patient	2	2
Injury	2	2
Claudication	2	2
Unspecified Kidney or Urinary Problem	2	2
Calcium Deposits/Calcification	2	2
Cardiac Arrest	2	2
Hematoma	2	2
Vascular Dissection	2	2
Thromboembolism	2	2
Peritonitis	1	1
Bradycardia	1	1
Impotence	1	1
Pneumonia	1	1
Pulmonary Edema	1	1
Shock	1	1
Perforation of Vessels	1	1

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