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	482	482
Material Fragmentation	344	344
Break	250	250
Adverse Event Without Identified Device or Use Problem	215	215
Material Deformation	159	159
Detachment of Device or Device Component	129	129
Leak/Splash	117	117
Suction Problem	105	105
Display or Visual Feedback Problem	104	104
Deflation Problem	100	100
Physical Resistance/Sticking	94	94
Material Separation	62	62
Failure to Deflate	53	53
Burst Container or Vessel	47	47
Inflation Problem	41	41
Device Difficult to Setup or Prepare	38	38
Entrapment of Device	35	35
Material Puncture/Hole	34	34
Material Disintegration	31	31
Failure to Advance	31	31
Degraded	29	29
Difficult to Remove	26	26
Pumping Problem	21	21
Defective Device	19	19
Mechanical Problem	14	14
Material Split, Cut or Torn	14	14
Stretched	14	14
Appropriate Term/Code Not Available	12	12
Material Twisted/Bent	12	12
Difficult to Advance	11	11
Material Integrity Problem	11	11
Suction Failure	10	10
Fluid/Blood Leak	10	10
Material Perforation	8	8
Fracture	6	6
Device Damaged Prior to Use	5	5
Device Displays Incorrect Message	5	5
Deformation Due to Compressive Stress	5	5
Separation Problem	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Difficult to Insert	5	5
Crack	4	4
Device Contamination with Chemical or Other Material	4	4
Failure to Prime	4	4
Mechanical Jam	4	4
Unraveled Material	4	4
Migration	3	3
Device Dislodged or Dislocated	3	3
Nonstandard Device	3	3
Decrease in Suction	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1604	1604
No Consequences Or Impact To Patient	359	359
No Known Impact Or Consequence To Patient	84	84
Insufficient Information	55	55
Foreign Body In Patient	52	52
Device Embedded In Tissue or Plaque	30	30
No Patient Involvement	23	23
Stroke/CVA	19	19
Low Blood Pressure/ Hypotension	17	17
Vascular Dissection	16	16
Cardiac Tamponade	16	16
Hemorrhage/Bleeding	15	15
Embolism/Embolus	15	15
Thrombosis/Thrombus	14	14
Death	12	12
Intracranial Hemorrhage	12	12
Myocardial Infarction	9	9
Hemorrhage, Cerebral	9	9
Perforation of Vessels	8	8
Bradycardia	7	7
Foreign Body Embolism	7	7
Pericardial Effusion	7	7
Vasoconstriction	7	7
Hematoma	7	7
Perforation	6	6
Obstruction/Occlusion	6	6
Hemorrhage, Subarachnoid	6	6
Ischemia	5	5
Pulmonary Embolism	5	5
Pain	5	5
No Code Available	5	5
Cardiac Perforation	5	5
Thromboembolism	5	5
Stenosis	4	4
Infarction, Cerebral	4	4
Renal Failure	4	4
Heart Failure/Congestive Heart Failure	4	4
Laceration(s)	4	4
Rupture	4	4
Thrombus	4	4
Thrombosis	3	3
Failure of Implant	3	3
Pseudoaneurysm	3	3
Unspecified Infection	3	3
Injury	3	3
Transient Ischemic Attack	3	3
Cardiac Arrest	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Edema	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3

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-12-2025
7	LeMaitre Vascular, Inc.	II	May-15-2024
8	LeMaitre Vascular, Inc.	II	Nov-11-2022
9	LeMaitre Vascular, Inc.	I	Apr-01-2020