TPLC - Total Product Life Cycle

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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	537	537
Material Fragmentation	341	341
Adverse Event Without Identified Device or Use Problem	155	156
Break	142	143
Detachment of Device or Device Component	128	128
Leak/Splash	96	98
Display or Visual Feedback Problem	89	89
Suction Problem	83	83
Burst Container or Vessel	73	73
Failure to Deflate	69	69
Material Deformation	65	65
Deflation Problem	62	62
Material Separation	52	52
Inflation Problem	34	37
Device Difficult to Setup or Prepare	32	33
Entrapment of Device	31	31
Degraded	31	31
Material Disintegration	31	31
Material Puncture/Hole	31	31
Pumping Problem	21	21
Fluid/Blood Leak	19	19
Material Split, Cut or Torn	18	18
Physical Resistance/Sticking	18	19
Difficult to Remove	18	18
Defective Device	14	14
Material Integrity Problem	10	10
Material Twisted/Bent	9	9
Difficult to Advance	8	8
Suction Failure	7	7
Deformation Due to Compressive Stress	7	7
Mechanical Problem	7	7
Material Perforation	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Stretched	5	5
Failure to Advance	4	4
Fracture	4	4
Appropriate Term/Code Not Available	4	4
Device Damaged Prior to Use	4	4
Difficult to Insert	4	4
Device Contamination with Chemical or Other Material	3	3
Unsealed Device Packaging	3	3
Contamination	3	3
Crack	3	3
Mechanical Jam	3	3
Separation Problem	3	3
Unexpected Shutdown	3	3
Device Dislodged or Dislocated	2	2
Nonstandard Device	2	2
Failure to Prime	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1738	1739
Insufficient Information	57	59
Foreign Body In Patient	50	50
Low Blood Pressure/ Hypotension	17	17
Hemorrhage/Bleeding	15	18
Thrombosis/Thrombus	15	16
Embolism/Embolus	15	15
Stroke/CVA	14	14
No Consequences Or Impact To Patient	13	13
Device Embedded In Tissue or Plaque	10	10
Vascular Dissection	9	9
Cardiac Tamponade	9	9
Myocardial Infarction	8	9
Foreign Body Embolism	7	7
Obstruction/Occlusion	7	8
Pericardial Effusion	7	7
Bradycardia	6	6
Cardiac Perforation	6	6
Perforation	6	6
Heart Failure/Congestive Heart Failure	5	5
Pulmonary Embolism	4	4
Ischemia	4	4
Pancreatitis	4	4
Pain	4	4
Laceration(s)	4	5
Perforation of Vessels	4	4
Hematoma	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Cardiac Arrest	3	3
Transient Ischemic Attack	3	3
Unspecified Infection	3	3
Hemolysis	3	3
Intracranial Hemorrhage	3	4
Pseudoaneurysm	3	3
Great Vessel Perforation	3	3
Anemia	2	2
No Known Impact Or Consequence To Patient	2	2
Failure of Implant	2	2
Abdominal Pain	2	2
Chest Pain	2	2
Cardiogenic Shock	2	2
Renal Failure	2	2
Tachycardia	2	2
Fistula	1	1
Air Embolism	1	1
Ischemia Stroke	1	1
Irritability	1	2
Loss of consciousness	1	1
Cardiac Enzyme Elevation	1	1