TPLC - Total Product Life Cycle

show TPLC since

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	444	444
Material Fragmentation	344	344
Break	245	245
Adverse Event Without Identified Device or Use Problem	206	206
Material Deformation	158	158
Detachment of Device or Device Component	116	116
Leak/Splash	110	110
Display or Visual Feedback Problem	102	102
Deflation Problem	99	99
Suction Problem	96	96
Physical Resistance/Sticking	94	94
Material Separation	62	62
Failure to Deflate	51	51
Inflation Problem	39	39
Device Difficult to Setup or Prepare	38	38
Entrapment of Device	35	35
Material Puncture/Hole	33	33
Failure to Advance	31	31
Material Disintegration	31	31
Burst Container or Vessel	29	29
Degraded	26	26
Difficult to Remove	25	25
Pumping Problem	21	21
Defective Device	19	19
Stretched	14	14
Mechanical Problem	13	13
Material Split, Cut or Torn	13	13
Material Twisted/Bent	12	12
Appropriate Term/Code Not Available	12	12
Material Integrity Problem	11	11
Difficult to Advance	11	11
Suction Failure	10	10
Fluid/Blood Leak	10	10
Material Perforation	8	8
Fracture	6	6
Manufacturing, Packaging or Shipping Problem	5	5
Separation Problem	5	5
Device Displays Incorrect Message	5	5
Deformation Due to Compressive Stress	5	5
Failure to Prime	4	4
Unraveled Material	4	4
Mechanical Jam	4	4
Device Damaged Prior to Use	4	4
Difficult to Insert	4	4
Device Contamination with Chemical or Other Material	3	3
Therapeutic or Diagnostic Output Failure	3	3
Unexpected Shutdown	3	3
Decrease in Suction	3	3
Migration	3	3
Device Dislodged or Dislocated	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1515	1515
No Consequences Or Impact To Patient	359	359
No Known Impact Or Consequence To Patient	84	84
Insufficient Information	54	54
Foreign Body In Patient	49	49
Device Embedded In Tissue or Plaque	30	30
No Patient Involvement	23	23
Stroke/CVA	19	19
Vascular Dissection	16	16
Embolism/Embolus	15	15
Cardiac Tamponade	14	14
Thrombosis/Thrombus	14	14
Low Blood Pressure/ Hypotension	14	14
Hemorrhage/Bleeding	13	13
Intracranial Hemorrhage	12	12
Death	12	12
Hemorrhage, Cerebral	9	9
Myocardial Infarction	9	9
Perforation	8	8
Hematoma	7	7
Pericardial Effusion	7	7
Bradycardia	7	7
Vasoconstriction	7	7
Perforation of Vessels	7	7
Obstruction/Occlusion	6	6
Hemorrhage, Subarachnoid	6	6
Foreign Body Embolism	6	6
Pulmonary Embolism	5	5
Pain	5	5
Thromboembolism	5	5
Ischemia	5	5
No Code Available	5	5
Laceration(s)	4	4
Renal Failure	4	4
Heart Failure/Congestive Heart Failure	4	4
Infarction, Cerebral	4	4
Cardiac Perforation	4	4
Rupture	4	4
Stenosis	4	4
Thrombus	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Edema	3	3
Failure of Implant	3	3
Thrombosis	3	3
Injury	3	3
Pseudoaneurysm	3	3
Embolus	3	3
Transient Ischemic Attack	3	3
Cardiac Arrest	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-15-2024
7	LeMaitre Vascular, Inc.	II	Nov-11-2022
8	LeMaitre Vascular, Inc.	I	Apr-01-2020