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	57	57

Device Problems	MDRs with this Device Problem	Events in those MDRs
Structural Problem	4459	4459
Device Tipped Over	2279	2279
Unintended Movement	1819	1818
Difficult to Remove	1772	1779
Appropriate Term/Code Not Available	1752	1752
Insufficient Information	1412	1412
Malposition of Device	1368	1418
Detachment of Device or Device Component	1351	1356
Obstruction of Flow	1132	1132
Patient Device Interaction Problem	1072	1123
Patient-Device Incompatibility	1060	1159
Adverse Event Without Identified Device or Use Problem	957	957
Fracture	768	768
Migration	682	684
Migration or Expulsion of Device	541	543
Positioning Problem	522	524
Inadequate Filtration Process	297	297
Activation Failure	291	291
Failure to Align	282	282
Material Deformation	225	227
Failure to Advance	140	140
Entrapment of Device	129	129
Improper or Incorrect Procedure or Method	108	108
Therapeutic or Diagnostic Output Failure	103	103
Break	102	102
Difficult or Delayed Activation	98	98
Activation, Positioning or Separation Problem	74	74
Material Perforation	59	59
Difficult to Advance	50	50
Material Twisted/Bent	45	45
Premature Activation	42	42
Material Puncture/Hole	42	42
Deformation Due to Compressive Stress	40	40
Activation Problem	38	38
Device Dislodged or Dislocated	38	38
Defective Device	34	34
Physical Resistance/Sticking	33	33
Difficult to Insert	33	33
Positioning Failure	32	32
Failure to Unfold or Unwrap	26	26
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
Difficult or Delayed Separation	11	11
Complete Blockage	11	11
Device Contamination with Chemical or Other Material	11	11
Defective Component	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Vessels	4792	4792
Internal Organ Perforation	2910	2910
No Clinical Signs, Symptoms or Conditions	1873	2038
Insufficient Information	1727	1727
Perforation	1591	1591
No Information	1572	1572
Pain	1326	1326
Anxiety	1257	1257
Abdominal Pain	952	952
No Consequences Or Impact To Patient	925	925
Thrombosis/Thrombus	901	901
Pulmonary Embolism	832	833
Device Embedded In Tissue or Plaque	665	665
Depression	554	554
Stenosis	496	496
Thrombosis	410	410
Vessel Or Plaque, Device Embedded In	379	379
Dyspnea	343	343
Coagulation Disorder	326	326
Occlusion	323	323
Chest Pain	322	322
Obstruction/Occlusion	305	305
Great Vessel Perforation	236	236
Foreign Body In Patient	170	170
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	153	153
Thrombus	151	151
No Known Impact Or Consequence To Patient	140	140
Injury	131	131
Discomfort	124	124
Hemorrhage/Bleeding	118	118
Death	113	113
Failure of Implant	113	113
Numbness	112	112
Swelling/ Edema	108	108
Distress	88	88
Unspecified Tissue Injury	85	84
Ambulation Difficulties	76	76
Emotional Changes	69	69
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	41	41
Cognitive Changes	37	37
Embolism/Embolus	34	34
Thromboembolism	33	33
Hematoma	30	30
Sleep Dysfunction	30	30
Embolus	29	29

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