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	526	526
Material Fragmentation	353	353
Break	252	252
Adverse Event Without Identified Device or Use Problem	224	224
Material Deformation	162	162
Detachment of Device or Device Component	145	145
Leak/Splash	118	120
Display or Visual Feedback Problem	108	108
Suction Problem	106	106
Deflation Problem	100	100
Physical Resistance/Sticking	95	95
Burst Container or Vessel	71	71
Material Separation	66	66
Failure to Deflate	61	61
Inflation Problem	41	44
Device Difficult to Setup or Prepare	39	39
Material Puncture/Hole	37	37
Entrapment of Device	36	36
Failure to Advance	31	31
Material Disintegration	31	31
Degraded	31	31
Difficult to Remove	28	28
Pumping Problem	21	21
Defective Device	19	19
Material Split, Cut or Torn	19	19
Stretched	14	14
Fluid/Blood Leak	14	14
Mechanical Problem	13	13
Difficult to Advance	13	13
Appropriate Term/Code Not Available	12	12
Material Twisted/Bent	12	12
Material Integrity Problem	12	12
Suction Failure	10	10
Material Perforation	8	8
Fracture	7	7
Device Damaged Prior to Use	5	5
Failure to Prime	5	5
Separation Problem	5	5
Device Displays Incorrect Message	5	6
Deformation Due to Compressive Stress	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Difficult to Insert	5	5
Device Contamination with Chemical or Other Material	4	4
Mechanical Jam	4	4
Unraveled Material	4	4
Unexpected Shutdown	4	4
Crack	4	4
Contamination	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Component	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1716	1716
No Consequences Or Impact To Patient	359	359
No Known Impact Or Consequence To Patient	84	85
Foreign Body In Patient	57	57
Insufficient Information	57	59
Device Embedded In Tissue or Plaque	31	31
No Patient Involvement	23	23
Stroke/CVA	19	19
Cardiac Tamponade	16	16
Low Blood Pressure/ Hypotension	16	16
Vascular Dissection	16	16
Hemorrhage/Bleeding	15	18
Embolism/Embolus	15	15
Thrombosis/Thrombus	14	14
Intracranial Hemorrhage	12	12
Death	12	12
Myocardial Infarction	9	9
Hemorrhage, Cerebral	9	9
Perforation of Vessels	8	8
Hematoma	7	7
Vasoconstriction	7	7
Bradycardia	7	7
Foreign Body Embolism	7	7
Obstruction/Occlusion	7	7
Pericardial Effusion	7	7
Ischemia	6	6
Perforation	6	6
Hemorrhage, Subarachnoid	6	6
No Code Available	5	5
Pain	5	5
Thromboembolism	5	5
Cardiac Perforation	5	5
Pulmonary Embolism	5	5
Stenosis	4	4
Renal Failure	4	4
Heart Failure/Congestive Heart Failure	4	4
Laceration(s)	4	4
Rupture	4	4
Infarction, Cerebral	4	4
Thrombus	4	4
Great Vessel Perforation	3	3
Pseudoaneurysm	3	3
Thrombosis	3	3
Embolus	3	3
Injury	3	3
Transient Ischemic Attack	3	3
Cardiac Arrest	3	3
Unspecified Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Edema	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