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
INSTYLLA, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	1278	1280
Adverse Event Without Identified Device or Use Problem	866	876
Break	599	600
Material Deformation	276	278
Leak/Splash	245	246
Detachment of Device or Device Component	149	154
Burst Container or Vessel	118	119
Difficult to Advance	110	111
Fracture	94	94
Device Damaged by Another Device	93	95
Material Separation	92	93
Difficult to Remove	90	91
Material Integrity Problem	87	87
Device Dislodged or Dislocated	72	72
Retraction Problem	69	69
Packaging Problem	65	65
Unintended Movement	64	64
Material Twisted/Bent	56	57
Entrapment of Device	56	57
Obstruction of Flow	43	43
No Apparent Adverse Event	40	41
Fluid/Blood Leak	33	33
Material Rupture	30	31
Deformation Due to Compressive Stress	27	28
Compatibility Problem	27	27
Stretched	24	25
Output Problem	24	24
Material Perforation	20	20
Defective Device	20	20
Collapse	18	18
Device Alarm System	18	18
Difficult to Open or Remove Packaging Material	16	18
Disconnection	16	16
Failure to Advance	15	15
Electrical /Electronic Property Problem	14	14
Difficult to Flush	12	12
Material Puncture/Hole	11	11
Contamination /Decontamination Problem	11	11
Device Displays Incorrect Message	11	11
Peeled/Delaminated	9	9
Crack	9	9
Device Fell	9	14
Unsealed Device Packaging	9	9
Display or Visual Feedback Problem	8	8
Material Split, Cut or Torn	8	8
Nonstandard Device	7	7
Positioning Problem	7	7
Incomplete or Missing Packaging	7	7
Material Too Soft/Flexible	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	2754	2765
Intracranial Hemorrhage	253	254
Foreign Body In Patient	149	151
Hemorrhage/Bleeding	142	144
Insufficient Information	136	141
Ischemia Stroke	123	123
Thrombosis/Thrombus	83	84
Obstruction/Occlusion	81	82
Unspecified Nervous System Problem	67	69
Stroke/CVA	65	66
Vasoconstriction	63	63
Vascular Dissection	63	65
Thromboembolism	59	61
Embolism/Embolus	56	57
Ischemia	56	56
Hematoma	55	55
Stenosis	49	50
Paresis	46	46
Device Embedded In Tissue or Plaque	45	45
Swelling/ Edema	44	44
Rupture	43	43
Hemorrhagic Stroke	39	39
Headache	37	37
Muscle Weakness	35	36
Transient Ischemic Attack	34	34
Nervous System Injury	30	30
Ruptured Aneurysm	28	28
Paralysis	27	27
Pain	26	26
Aneurysm	26	26
Pseudoaneurysm	25	25
Dysphasia	25	26
Perforation of Vessels	24	25
Cerebral Edema	22	22
Hydrocephalus	20	20
Convulsion/Seizure	20	20
Cognitive Changes	19	20
Perforation	18	18
Visual Disturbances	18	18
Coma	17	17
Visual Impairment	17	17
Unspecified Infection	16	16
Confusion/ Disorientation	14	14
Low Blood Pressure/ Hypotension	13	13
Failure of Implant	13	13
Fistula	13	13
Nerve Damage	11	11
Loss of Vision	11	11
Respiratory Insufficiency	10	10
Unintended Radiation Exposure	10	10