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
HOTSPUR TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MIVI NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	718	718
Material Rupture	520	520
Aspiration Issue	496	496
Device Displays Incorrect Message	456	456
Material Deformation	455	455
Adverse Event Without Identified Device or Use Problem	418	418
Material Fragmentation	364	364
Kinked	235	235
Material Separation	235	235
Physical Resistance/Sticking	219	219
Deflation Problem	216	216
Detachment of Device or Device Component	195	195
Device Damaged Prior to Use	176	176
Leak/Splash	166	166
Suction Problem	140	140
Failure to Advance	129	129
Physical Resistance	126	126
Detachment Of Device Component	118	118
Display or Visual Feedback Problem	110	110
Entrapment of Device	109	109
Device Operates Differently Than Expected	85	85
Fracture	81	81
Out-Of-Box Failure	75	75
Device Handling Problem	70	70
Burst Container or Vessel	68	68
Failure to Prime	63	63
Difficult to Remove	59	59
Material Puncture/Hole	56	56
Inflation Problem	55	55
Stretched	55	55
Collapse	53	53
Device Difficult to Setup or Prepare	45	45
Fluid/Blood Leak	44	44
Failure to Deflate	43	43
Material Twisted/Bent	39	39
Deformation Due to Compressive Stress	37	37
Difficult to Advance	36	36
Bent	32	32
Material Disintegration	32	32
Device Dislodged or Dislocated	28	28
Hole In Material	27	27
Defective Device	27	27
Material Integrity Problem	26	26
Unraveled Material	25	25
Material Perforation	22	22
Difficult to Insert	22	22
Pumping Problem	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	2476	2476
No Clinical Signs, Symptoms or Conditions	1371	1371
No Known Impact Or Consequence To Patient	456	456
No Patient Involvement	344	344
Device Embedded In Tissue or Plaque	149	149
Foreign Body In Patient	96	97
Death	82	82
No Information	55	55
Insufficient Information	53	53
Stroke/CVA	47	47
No Code Available	36	37
Low Blood Pressure/ Hypotension	36	36
Renal Failure	31	31
Myocardial Infarction	30	30
Hemorrhage/Bleeding	28	28
Thrombus	26	26
Vascular Dissection	26	26
Intracranial Hemorrhage	24	25
Embolism	23	23
Bradycardia	22	22
Cardiac Tamponade	20	20
Patient Problem/Medical Problem	19	19
Pulmonary Embolism	19	19
Perforation	17	17
Hemorrhage, Cerebral	16	16
Hemoptysis	16	16
Hemorrhage, Subarachnoid	15	15
Pain	15	15
Infarction, Cerebral	14	15
Hemolysis	13	13
Perforation of Vessels	13	13
Blood Loss	13	13
Embolism/Embolus	13	13
Injury	12	12
Stenosis	12	12
Cardiac Arrest	12	12
Thrombosis/Thrombus	11	11
Hematoma	11	11
Transient Ischemic Attack	10	10
Thromboembolism	9	9
Tachycardia	9	9
Occlusion	9	9
Heart Failure	9	9
Vessel Or Plaque, Device Embedded In	9	9
Chest Pain	9	9
Pericardial Effusion	8	8
Vasoconstriction	8	8
Ischemia	8	8
Cardiopulmonary Arrest	8	8
Obstruction/Occlusion	7	7

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	I	May-07-2020
2	Applied Medical Resources Corp	II	Sep-25-2012
3	Arrow International Inc	I	Nov-18-2021
4	Arrow International Inc	II	Sep-30-2016
5	Arrow International Inc	II	Jun-25-2009
6	Arrow International Inc	II	Jun-24-2009
7	Boston Scientific Corporation	I	Apr-18-2016
8	Boston Scientific Corporation	II	Aug-13-2015
9	Edwards Lifesciences, LLC	II	Nov-06-2023
10	Edwards Lifesciences, LLC	II	Oct-28-2022
11	Edwards Lifesciences, LLC	II	Aug-26-2017
12	INARI MEDICAL	II	Jun-09-2020
13	Invatec Llc	II	Jun-07-2013
14	LeMaitre Vascular, Inc.	II	May-15-2024
15	LeMaitre Vascular, Inc.	II	Nov-11-2022
16	LeMaitre Vascular, Inc.	I	Apr-01-2020
17	LeMaitre Vascular, Inc.	II	Dec-04-2015
18	Spectranetics Corporation	II	Aug-09-2010
19	Vascular Solutions, Inc.	II	Aug-04-2011
20	Vascular Solutions, Inc.	II	Dec-17-2009