TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	692	692
Material Rupture	502	502
Aspiration Issue	488	488
Device Displays Incorrect Message	455	455
Material Deformation	452	452
Adverse Event Without Identified Device or Use Problem	410	410
Material Fragmentation	360	360
Kinked	230	230
Material Separation	229	229
Physical Resistance/Sticking	219	219
Deflation Problem	207	207
Detachment of Device or Device Component	189	189
Device Damaged Prior to Use	175	175
Leak/Splash	163	163
Suction Problem	140	140
Physical Resistance	126	126
Failure to Advance	124	124
Display or Visual Feedback Problem	110	110
Entrapment of Device	106	106
Detachment Of Device Component	85	85
Out-Of-Box Failure	75	75
Fracture	73	73
Device Operates Differently Than Expected	71	71
Device Handling Problem	70	70
Burst Container or Vessel	66	66
Failure to Prime	63	63
Difficult to Remove	56	56
Material Puncture/Hole	56	56
Stretched	54	54
Inflation Problem	54	54
Collapse	53	53
Device Difficult to Setup or Prepare	45	45
Failure to Deflate	43	43
Fluid/Blood Leak	43	43
Material Twisted/Bent	39	39
Deformation Due to Compressive Stress	37	37
Difficult to Advance	35	35
Bent	32	32
Material Disintegration	32	32
Defective Device	27	27
Hole In Material	27	27
Material Integrity Problem	26	26
Device Dislodged or Dislocated	25	25
Unraveled Material	25	25
Material Perforation	22	22
Pumping Problem	21	21
Difficult to Insert	21	21
Crack	20	20
Mechanical Problem	18	18
Appropriate Term/Code Not Available	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	2383	2383
No Clinical Signs, Symptoms or Conditions	1371	1371
No Known Impact Or Consequence To Patient	428	428
No Patient Involvement	343	343
Device Embedded In Tissue or Plaque	132	132
Foreign Body In Patient	79	80
Death	77	77
Insufficient Information	53	53
Stroke/CVA	45	45
No Information	45	45
Low Blood Pressure/ Hypotension	35	35
No Code Available	32	33
Myocardial Infarction	30	30
Renal Failure	28	28
Hemorrhage/Bleeding	27	27
Vascular Dissection	26	26
Embolism	23	23
Intracranial Hemorrhage	23	24
Bradycardia	22	22
Thrombus	21	21
Cardiac Tamponade	20	20
Patient Problem/Medical Problem	19	19
Pulmonary Embolism	16	16
Hemoptysis	16	16
Hemorrhage, Subarachnoid	14	14
Infarction, Cerebral	14	15
Perforation	14	14
Hemorrhage, Cerebral	14	14
Embolism/Embolus	13	13
Blood Loss	13	13
Pain	13	13
Injury	12	12
Hemolysis	12	12
Stenosis	12	12
Thrombosis/Thrombus	11	11
Hematoma	11	11
Cardiac Arrest	11	11
Perforation of Vessels	11	11
Transient Ischemic Attack	10	10
Chest Pain	9	9
Tachycardia	9	9
Thromboembolism	9	9
Cardiopulmonary Arrest	8	8
Pericardial Effusion	8	8
Vessel Or Plaque, Device Embedded In	8	8
Heart Failure	8	8
Vasoconstriction	8	8
Ischemia	8	8
Occlusion	8	8
Laceration(s)	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	I	May-07-2020
2	Arrow International Inc	I	Nov-18-2021
3	Arrow International Inc	II	Sep-30-2016
4	Boston Scientific Corporation	I	Apr-18-2016
5	Boston Scientific Corporation	II	Aug-13-2015
6	Edwards Lifesciences, LLC	II	Nov-06-2023
7	Edwards Lifesciences, LLC	II	Oct-28-2022
8	Edwards Lifesciences, LLC	II	Aug-26-2017
9	INARI MEDICAL	II	Jun-09-2020
10	LeMaitre Vascular, Inc.	II	May-15-2024
11	LeMaitre Vascular, Inc.	II	Nov-11-2022
12	LeMaitre Vascular, Inc.	I	Apr-01-2020
13	LeMaitre Vascular, Inc.	II	Dec-04-2015