TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABLATIVE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AGILE DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARGON MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INSTYLLA, INC.
	SUBSTANTIALLY EQUIVALENT	2
INVERA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MERCATOR MEDSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUATICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
SMARTWISE SWEDEN AB
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU ZENITH VASCULAR SCITECH LIMITED
	SUBSTANTIALLY EQUIVALENT	1
TRANSIT SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
TRISALUS LIFE SCIENCES
	SUBSTANTIALLY EQUIVALENT	1
VASCUPATENT MEDICAL (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VVT MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
WALLABY MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	1337	1339
Adverse Event Without Identified Device or Use Problem	898	908
Break	618	618
Material Deformation	290	292
Leak/Splash	270	271
Detachment of Device or Device Component	163	168
Burst Container or Vessel	127	128
Difficult to Advance	122	123
Fracture	116	116
Device Damaged by Another Device	100	102
Material Separation	97	98
Difficult to Remove	96	97
Material Integrity Problem	92	92
Retraction Problem	91	91
Device Dislodged or Dislocated	74	74
Packaging Problem	70	70
Entrapment of Device	69	70
Unintended Movement	67	67
Material Twisted/Bent	65	65
Obstruction of Flow	43	43
Fluid/Blood Leak	42	42
No Apparent Adverse Event	41	42
Material Rupture	33	34
Deformation Due to Compressive Stress	32	33
Compatibility Problem	29	29
Stretched	23	24
Material Perforation	20	20
Collapse	19	19
Defective Device	19	19
Output Problem	18	18
Device Alarm System	18	18
Disconnection	16	16
Difficult to Open or Remove Packaging Material	16	18
Electrical /Electronic Property Problem	14	14
Peeled/Delaminated	13	13
Difficult to Flush	12	12
Device Displays Incorrect Message	11	11
Contamination /Decontamination Problem	11	11
Material Split, Cut or Torn	10	10
Failure to Advance	10	10
Unsealed Device Packaging	9	9
Device Fell	9	14
Material Puncture/Hole	8	8
Nonstandard Device	8	8
Display or Visual Feedback Problem	8	8
Crack	8	8
Positioning Problem	7	7
Material Too Soft/Flexible	7	7
Incomplete or Missing Packaging	7	7
Device Contaminated During Manufacture or Shipping	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2979	2990
Intracranial Hemorrhage	256	257
Foreign Body In Patient	153	155
Hemorrhage/Blood Loss/Bleeding	149	151
Insufficient Information	137	142
Ischemia Stroke	129	129
Thrombosis/Thrombus	84	85
Obstruction/Occlusion	81	82
Vascular Dissection	68	70
Unspecified Nervous System Problem	67	69
Vasoconstriction	66	66
Stroke/CVA	65	66
Embolism/Embolus	60	61
Thromboembolism	59	61
Hematoma	58	58
Ischemia	57	57
Stenosis	51	52
Device Embedded In Tissue or Plaque	47	47
Paresis	46	46
Swelling/ Edema	45	45
Rupture	44	44
Hemorrhagic Stroke	39	39
Headache	37	37
Muscle Weakness/Atrophy	36	37
Transient Ischemic Attack	34	34
Nervous System Injury	32	32
Pain	29	29
Ruptured Aneurysm	28	28
Pseudoaneurysm	27	27
Paralysis	27	27
Perforation of Vessels	26	27
Aneurysm	26	26
Dysphasia	25	26
Cerebral Edema	22	22
Cognitive Changes	20	21
Convulsion/Seizure	20	20
Hydrocephalus	20	20
Visual Disturbances	19	19
Coma	17	17
Visual Impairment	17	17
Low Blood Pressure/ Hypotension	16	16
Unspecified Infection	16	16
Perforation	16	16
Confusion/ Disorientation	14	14
Fistula	14	14
Failure of Implant	13	13
Respiratory Insufficiency	11	11
Nerve Damage	11	11
Respiratory Failure	11	11
Loss of Vision	11	11