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	3
MIVI NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	418	418
Material Fragmentation	351	351
Break	343	343
Material Deformation	299	299
Adverse Event Without Identified Device or Use Problem	237	237
Physical Resistance/Sticking	189	189
Detachment of Device or Device Component	146	146
Deflation Problem	135	135
Suction Problem	124	124
Leak/Splash	116	116
Material Separation	109	109
Display or Visual Feedback Problem	104	104
Failure to Advance	61	61
Inflation Problem	48	48
Material Puncture/Hole	44	44
Failure to Deflate	43	43
Device Damaged Prior to Use	40	40
Device Difficult to Setup or Prepare	39	39
Entrapment of Device	38	38
Material Disintegration	31	31
Difficult to Remove	29	29
Stretched	25	25
Burst Container or Vessel	25	25
Material Twisted/Bent	24	24
Pumping Problem	21	21
Defective Device	20	20
Fracture	18	18
Suction Failure	15	15
Material Perforation	13	13
Difficult to Advance	13	13
Mechanical Problem	13	13
Degraded	13	13
Device Dislodged or Dislocated	13	13
Material Integrity Problem	13	13
Material Split, Cut or Torn	12	12
Appropriate Term/Code Not Available	12	12
Fluid/Blood Leak	11	11
Deformation Due to Compressive Stress	10	10
Device Displays Incorrect Message	9	9
Separation Problem	8	8
Device Fell	8	8
Unraveled Material	7	7
Pressure Problem	7	7
Collapse	7	7
Crack	6	6
Decrease in Suction	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Unintended Movement	5	5
Difficult to Insert	5	5
Unexpected Shutdown	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1371	1371
No Consequences Or Impact To Patient	731	731
No Known Impact Or Consequence To Patient	209	209
No Patient Involvement	96	96
Device Embedded In Tissue or Plaque	62	62
Foreign Body In Patient	57	58
Insufficient Information	53	53
Death	25	25
Stroke/CVA	24	24
Low Blood Pressure/ Hypotension	20	20
Vascular Dissection	20	20
Myocardial Infarction	18	18
Cardiac Tamponade	17	17
Embolism/Embolus	13	13
Hemorrhage/Bleeding	12	12
Intracranial Hemorrhage	12	12
Thrombosis/Thrombus	11	11
Embolism	10	10
Bradycardia	10	10
Thrombus	9	9
Perforation of Vessels	9	9
Hemorrhage, Cerebral	9	9
Hemoptysis	9	9
Perforation	9	9
Vessel Or Plaque, Device Embedded In	7	7
Pulmonary Embolism	7	7
Cardiac Arrest	7	7
No Code Available	7	7
Pericardial Effusion	7	7
Injury	7	7
Hematoma	7	7
Vasoconstriction	7	7
Transient Ischemic Attack	6	6
Foreign Body Embolism	6	6
Ischemia	6	6
No Information	6	6
Renal Failure	6	6
Hemorrhage, Subarachnoid	6	6
Chest Pain	5	5
Cardiac Perforation	5	5
Laceration(s)	5	5
Pain	5	5
Stenosis	5	5
Thromboembolism	5	5
Obstruction/Occlusion	5	5
Rupture	5	5
Occlusion	5	5
Blood Loss	4	4
Thrombosis	4	4
Heart Failure	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	I	May-07-2020
2	Arrow International Inc	I	Nov-18-2021
3	Edwards Lifesciences, LLC	II	Nov-06-2023
4	Edwards Lifesciences, LLC	II	Oct-28-2022
5	INARI MEDICAL	II	Jun-09-2020
6	LeMaitre Vascular, Inc.	II	May-15-2024
7	LeMaitre Vascular, Inc.	II	Nov-11-2022
8	LeMaitre Vascular, Inc.	I	Apr-01-2020