TPLC - Total Product Life Cycle

• Device: filter, intravascular, cardiovascular
• Regulation Description: Cardiovascular intravascular filter.
• 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
2020	5404	5404
2021	5357	5516
2022	2191	2196
2023	584	584
2024	406	406
2025	190	190

Device Problems	MDRs with this Device Problem	Events in those MDRs
Structural Problem	4475	4475
Device Tipped Over	2296	2296
Unintended Movement	1824	1823
Difficult to Remove	1789	1796
Appropriate Term/Code Not Available	1752	1752
Insufficient Information	1414	1414
Detachment of Device or Device Component	1390	1395
Malposition of Device	1373	1423
Obstruction of Flow	1145	1145
Patient Device Interaction Problem	1072	1123
Patient-Device Incompatibility	1067	1166
Adverse Event Without Identified Device or Use Problem	961	961
Fracture	775	775
Migration	686	688
Migration or Expulsion of Device	541	543
Positioning Problem	524	526
Activation Failure	308	308
Inadequate Filtration Process	304	304
Failure to Align	285	285
Material Deformation	227	229
Failure to Advance	159	159
Entrapment of Device	129	129
Improper or Incorrect Procedure or Method	115	115
Break	106	106
Therapeutic or Diagnostic Output Failure	103	103
Difficult or Delayed Activation	100	100
Activation, Positioning or Separation Problem	74	74
Material Perforation	59	59
Difficult to Advance	53	53
Material Puncture/Hole	48	48
Material Twisted/Bent	47	47
Deformation Due to Compressive Stress	45	45
Device Dislodged or Dislocated	44	44
Premature Activation	43	43
Difficult to Insert	39	39
Activation Problem	39	39
Defective Device	34	34
Positioning Failure	34	34
Physical Resistance/Sticking	33	33
Failure to Unfold or Unwrap	30	30
Retraction Problem	23	23
Difficult to Open or Close	21	21
Output Problem	19	19
Material Split, Cut or Torn	18	18
Off-Label Use	16	16
Loss of or Failure to Bond	12	12
Complete Blockage	11	11
Device Contamination with Chemical or Other Material	11	11
Device Misassembled During Manufacturing /Shipping	11	11
Difficult or Delayed Separation	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Vessels	4813	4813
Internal Organ Perforation	2923	2923
No Clinical Signs, Symptoms or Conditions	1952	2117
Insufficient Information	1740	1740
Perforation	1591	1591
No Information	1572	1572
Pain	1339	1339
Anxiety	1268	1268
Abdominal Pain	954	954
No Consequences Or Impact To Patient	925	925
Thrombosis/Thrombus	918	918
Pulmonary Embolism	840	841
Device Embedded In Tissue or Plaque	675	675
Depression	562	562
Stenosis	499	499
Thrombosis	410	410
Vessel Or Plaque, Device Embedded In	379	379
Dyspnea	347	347
Coagulation Disorder	326	326
Chest Pain	326	326
Occlusion	323	323
Obstruction/Occlusion	309	309
Great Vessel Perforation	238	238
Foreign Body In Patient	187	187
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	162	162
Thrombus	151	151
No Known Impact Or Consequence To Patient	140	140
Injury	131	131
Discomfort	124	124
Hemorrhage/Bleeding	123	123
Death	113	113
Failure of Implant	113	113
Numbness	112	112
Swelling/ Edema	109	109
Distress	98	98
Unspecified Tissue Injury	85	84
Ambulation Difficulties	79	79
Emotional Changes	70	70
Cardiac Perforation	68	68
No Code Available	60	60
Bowel Perforation	54	54
Swelling	53	53
Unspecified Mental, Emotional or Behavioural Problem	47	47
Fatigue	43	43
Cognitive Changes	37	37
Embolism/Embolus	35	35
Thromboembolism	33	33
Sleep Dysfunction	31	31
Peripheral Edema	31	31
Hematoma	30	30

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