TPLC - Total Product Life Cycle

show TPLC since

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	131	131
Material Deformation	61	61
Break	42	42
Positioning Problem	41	41
Activation Failure	38	38
Adverse Event Without Identified Device or Use Problem	36	36
Positioning Failure	34	34
Use of Device Problem	26	26
Material Twisted/Bent	21	21
Migration	19	20
Fracture	15	15
Failure to Advance	15	15
Defective Device	14	14
Difficult to Remove	13	13
Appropriate Device Problem Term/Code Not Available	11	11
Detachment of Device or Device Component	10	10
Unraveled Material	9	9
Material Separation	8	8
Device-Device Incompatibility	8	8
Difficult or Delayed Positioning	7	7
Material Integrity Problem	7	7
Device Stenosis	6	6
Material Rupture	6	6
Premature Activation	6	6
Malposition of Device	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
Unsealed Device Packaging	3	3
Insufficient Device Problem Information	3	3
Device Misassembled During Manufacturing /Shipping	3	3
No Apparent Adverse Event	2	2
Device Dislodged or Dislocated	2	2
Separation Failure	2	2
Deformation Due to Compressive Stress	2	2
Entrapment of Device	2	2
Off-Label Use	2	2
Material Puncture/Hole	2	2
Wrong Label	2	2
Separation Problem	2	2
Packaging Problem	1	1
Infusion or Flow Problem	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Component or Accessory Incompatibility	1	1
Difficult or Delayed Activation	1	1
Material Fragmentation	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	327	327
Obstruction/Occlusion	16	16
Hemorrhage/Blood Loss/Bleeding	13	13
Insufficient Information	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Restenosis	6	6
Stenosis of the esophagus	6	6
Thrombosis/Thrombus	6	6
Dyspnea	5	5
Aneurysm	5	5
Stenosis	4	4
Hypoxia	4	4
Death	4	4
Erosion	4	4
Foreign Body In Patient	4	4
Discomfort	3	3
Foreign Body Embolism	3	3
Respiratory Insufficiency	3	3
Inflammation	3	3
No Consequences Or Impact To Patient	3	3
Calcium Deposits/Calcification	2	2
Unspecified Kidney or Urinary Problem	2	2
Hematoma	2	2
Ischemia	2	2
Blood Loss	2	2
Pseudoaneurysm	2	2
Perforation	2	2
Occlusion	2	2
Cardiac Arrest	2	2
Renal Failure	2	2
Unspecified Infection	2	2
Bradycardia	1	1
Swelling/ Edema	1	1
Perforation of Vessels	1	1
Rupture	1	1
Ischemic Heart Disease	1	1
Respiratory Failure	1	1
Ulcer	1	1
Pneumonia	1	2
Shock	1	1
Pneumothorax	1	1
Cough	1	1
Embolism	1	1
Anemia	1	1
Granuloma	1	1
Device Embedded In Tissue or Plaque	1	1
Injury	1	1
Laceration(s) of Esophagus	1	1

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