TPLC - Total Product Life Cycle

• Device: filter, intravascular, cardiovascular
• Product Code: DTK
• Regulation Number: 870.3375
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALN S.A.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ARGON MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	3

MDR Year	MDR Reports	MDR Events
2019	6467	6474
2020	5404	5404
2021	5357	5516
2022	2191	2196
2023	584	584
2024	374	374

Device Problems	MDRs with this Device Problem	Events in those MDRs
Structural Problem	4712	4712
Insufficient Information	4035	4035
Appropriate Term/Code Not Available	4015	4015
Difficult to Remove	2985	2993
Device Tipped Over	2430	2430
Malposition of Device	2223	2275
Unintended Movement	2027	2026
Patient Device Interaction Problem	1879	1932
Detachment of Device or Device Component	1807	1817
Adverse Event Without Identified Device or Use Problem	1470	1470
Obstruction of Flow	1334	1334
Fracture	1302	1302
Patient-Device Incompatibility	1277	1378
Migration or Expulsion of Device	1010	1013
Migration	992	994
Failure to Align	974	974
Positioning Problem	590	592
Inadequate Filtration Process	331	331
Activation Failure	306	306
Entrapment of Device	290	290
Material Deformation	284	286
Failure to Advance	146	146
Therapeutic or Diagnostic Output Failure	123	123
Break	115	115
Difficult or Delayed Activation	110	110
Improper or Incorrect Procedure or Method	103	103
Activation, Positioning or Separation Problem	99	99
Material Perforation	86	86
Material Twisted/Bent	78	78
Difficult to Advance	57	57
Material Puncture/Hole	55	55
Activation Problem	49	49
Defective Device	49	49
Premature Activation	46	46
Device Dislodged or Dislocated	42	42
Deformation Due to Compressive Stress	42	42
Difficult to Insert	41	41
Physical Resistance/Sticking	35	35
Positioning Failure	34	34
Failure to Unfold or Unwrap	26	26
Defective Component	25	25
Retraction Problem	24	24
Difficult to Open or Close	22	22
Output Problem	21	21
Material Split, Cut or Torn	20	20
Complete Blockage	16	16
Material Separation	15	15
Difficult or Delayed Positioning	13	13
Off-Label Use	12	12
Unexpected Therapeutic Results	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Vessels	7501	7501
No Information	4210	4210
Internal Organ Perforation	3941	3941
Perforation	2168	2168
Pain	2113	2113
No Clinical Signs, Symptoms or Conditions	2001	2173
Anxiety	1816	1816
Insufficient Information	1721	1721
No Consequences Or Impact To Patient	1570	1577
Pulmonary Embolism	1421	1422
Abdominal Pain	1307	1307
Thrombosis	1094	1094
Thrombosis/Thrombus	948	948
Vessel Or Plaque, Device Embedded In	925	925
Device Embedded In Tissue or Plaque	835	835
Depression	697	697
Stenosis	680	680
Occlusion	652	652
Coagulation Disorder	522	522
Dyspnea	482	482
Chest Pain	482	482
No Code Available	419	419
Thrombus	394	394
Obstruction/Occlusion	330	330
Injury	301	301
No Known Impact Or Consequence To Patient	289	289
Great Vessel Perforation	282	282
Death	258	258
Foreign Body In Patient	204	204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	159	159
Hemorrhage/Bleeding	149	149
Discomfort	145	145
Swelling	142	142
Failure of Implant	137	137
Numbness	135	135
Swelling/ Edema	115	115
Cardiac Perforation	105	105
Distress	102	102
Ambulation Difficulties	96	96
Embolus	95	95
Emotional Changes	94	94
Unspecified Tissue Injury	85	84
Bowel Perforation	82	82
Fatigue	64	64
Thromboembolism	57	57
Hematoma	56	56
Unspecified Mental, Emotional or Behavioural Problem	47	47
Disability	44	44
Nausea	39	39
Cognitive Changes	39	39

Recalls
Manufacturer		Recall Class	Date Posted
1	Argon Medical Devices, Inc	II	Jul-27-2023
2	Cook Medical Incorporated	III	Apr-06-2022
3	Cook Medical Incorporated	III	Mar-19-2019