TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	3
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
MIVI NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	632	632
Material Fragmentation	359	359
Adverse Event Without Identified Device or Use Problem	158	159
Detachment of Device or Device Component	129	129
Break	128	129
Leak/Splash	95	95
Burst Container or Vessel	90	90
Display or Visual Feedback Problem	89	89
Suction Problem	83	83
Failure to Deflate	77	77
Material Deformation	65	65
Deflation Problem	62	62
Material Separation	49	49
Device Difficult to Setup or Prepare	34	35
Degraded	31	31
Material Disintegration	30	30
Inflation Problem	30	30
Entrapment of Device	29	29
Material Puncture/Hole	29	29
Difficult to Remove	22	22
Pumping Problem	21	21
Material Split, Cut or Torn	19	19
Fluid/Blood Leak	17	17
Physical Resistance/Sticking	16	16
Defective Device	11	11
Suction Failure	10	10
Material Twisted/Bent	10	10
Material Integrity Problem	10	10
Difficult to Advance	8	8
Deformation Due to Compressive Stress	7	7
Material Perforation	6	6
Mechanical Problem	6	6
Difficult to Insert	5	5
Stretched	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Failure to Advance	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Unsealed Device Packaging	3	3
Fracture	3	3
Crack	3	3
Contamination	3	3
Device Contamination with Chemical or Other Material	3	3
Nonstandard Device	3	3
Unexpected Shutdown	3	3
Separation Problem	3	3
Air/Gas in Device	3	3
Mechanical Jam	3	3
Unraveled Material	2	2
Device Damaged Prior to Use	2	2
Human-Device Interface Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1920	1921
Insufficient Information	57	59
Foreign Body In Patient	51	51
Low Blood Pressure/ Hypotension	17	17
Thrombosis/Thrombus	15	16
Hemorrhage/Blood Loss/Bleeding	15	18
Embolism/Embolus	15	15
Stroke/CVA	14	14
No Consequences Or Impact To Patient	13	13
Device Embedded In Tissue or Plaque	10	10
Foreign Body Embolism	9	9
Cardiac Tamponade	9	9
Vascular Dissection	9	9
Myocardial Infarction	8	9
Pericardial Effusion	8	8
Obstruction/Occlusion	7	8
Bradycardia	7	7
Perforation	6	6
Cardiac Perforation	6	6
Perforation of Vessels	6	6
Heart Failure/Congestive Heart Failure	5	5
Pancreatitis	4	4
Pulmonary Embolism	4	4
Pain	4	4
Laceration(s)	4	5
Ischemia	4	4
Pseudoaneurysm	3	3
Intracranial Hemorrhage	3	4
Unspecified Infection	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Renal Failure	3	3
Cardiac Arrest	3	3
Hemolysis	3	3
Hematoma	3	3
Great Vessel Perforation	3	3
Transient Ischemic Attack	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Abdominal Pain	2	2
Cardiogenic Shock	2	2
No Known Impact Or Consequence To Patient	2	2
Chest Pain	2	2
Tachycardia	2	2
Anemia	2	2
Failure of Implant	2	2
Respiratory Tract Infection	1	1
Paresis	1	1
Rupture	1	1
Facial Paralysis	1	1
Loss of consciousness	1	1
Irritability	1	2