TPLC - Total Product Life Cycle

• Device: catheter, embolectomy
• Product Code: DXE
• Regulation Number: 870.5150
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
APPLIED MEDICAL RESOURCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIVI NEUROVASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	594	594
2020	547	547
2021	333	333
2022	463	463
2023	435	435
2024	124	124

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	394	394
Break	333	333
Material Fragmentation	327	327
Material Deformation	297	297
Adverse Event Without Identified Device or Use Problem	222	222
Physical Resistance/Sticking	189	189
Detachment of Device or Device Component	135	135
Deflation Problem	134	134
Suction Problem	119	119
Material Separation	109	109
Leak/Splash	105	105
Display or Visual Feedback Problem	95	95
Failure to Advance	61	61
Inflation Problem	48	48
Material Puncture/Hole	43	43
Device Damaged Prior to Use	40	40
Entrapment of Device	38	38
Device Difficult to Setup or Prepare	37	37
Material Disintegration	31	31
Failure to Deflate	29	29
Difficult to Remove	28	28
Stretched	25	25
Material Twisted/Bent	24	24
Pumping Problem	19	19
Defective Device	18	18
Fracture	18	18
Suction Failure	15	15
Material Integrity Problem	13	13
Device Dislodged or Dislocated	13	13
Material Perforation	13	13
Burst Container or Vessel	12	12
Difficult to Advance	12	12
Appropriate Term/Code Not Available	12	12
Material Split, Cut or Torn	11	11
Fluid/Blood Leak	11	11
Mechanical Problem	11	11
Deformation Due to Compressive Stress	10	10
Device Displays Incorrect Message	9	9
Device Fell	8	8
Separation Problem	8	8
Pressure Problem	7	7
Unraveled Material	7	7
Degraded	7	7
Collapse	7	7
Crack	6	6
Decrease in Suction	6	6
Difficult to Insert	5	5
Use of Device Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Component Missing	5	5
Unintended Movement	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Unexpected Shutdown	5	5
Mechanical Jam	4	4
Device Contamination with Chemical or Other Material	4	4
Migration	4	4
Failure to Prime	4	4
Misconnection	4	4
Nonstandard Device	3	3
Retraction Problem	3	3
Device Contamination with Body Fluid	3	3
Defective Component	3	3
Power Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Handling Problem	3	3
Device Damaged by Another Device	2	2
Incomplete or Missing Packaging	2	2
Obstruction of Flow	2	2
Device Slipped	2	2
Migration or Expulsion of Device	2	2
Unsealed Device Packaging	2	2
Peeled/Delaminated	2	2
Failure to Power Up	2	2
Contamination	2	2
Positioning Failure	2	2
Difficult to Fold, Unfold or Collapse	2	2
Difficult to Flush	2	2
Flushing Problem	1	1
Corroded	1	1
Complete Blockage	1	1
Device Alarm System	1	1
Backflow	1	1
Device Emits Odor	1	1
Pacing Problem	1	1
Material Frayed	1	1
Melted	1	1
Loose or Intermittent Connection	1	1
Failure to Osseointegrate	1	1
Unstable	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Decrease in Pressure	1	1
Product Quality Problem	1	1
Failure to Align	1	1
Failure to Cut	1	1
Malposition of Device	1	1
Failure to Deliver	1	1
Fitting Problem	1	1
Osseointegration Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1251	1251
No Consequences Or Impact To Patient	731	731
No Known Impact Or Consequence To Patient	209	209
No Patient Involvement	96	96
Device Embedded In Tissue or Plaque	62	62
Foreign Body In Patient	50	51
Insufficient Information	49	49
Death	25	25
Stroke/CVA	24	24
Vascular Dissection	20	20
Low Blood Pressure/ Hypotension	19	19
Myocardial Infarction	18	18
Cardiac Tamponade	17	17
Embolism/Embolus	12	12
Hemorrhage/Bleeding	11	11
Intracranial Hemorrhage	11	11
Embolism	10	10
Bradycardia	10	10
Thrombosis/Thrombus	10	10
Hemorrhage, Cerebral	9	9
Hemoptysis	9	9
Perforation of Vessels	9	9
Thrombus	9	9
Vasoconstriction	7	7
Injury	7	7
Hematoma	7	7
Cardiac Arrest	7	7
Vessel Or Plaque, Device Embedded In	7	7
Pulmonary Embolism	7	7
No Code Available	7	7
Pericardial Effusion	6	6
No Information	6	6
Foreign Body Embolism	6	6
Hemorrhage, Subarachnoid	6	6
Transient Ischemic Attack	6	6
Perforation	6	6
Renal Failure	6	6
Ischemia	6	6
Laceration(s)	5	5
Occlusion	5	5
Pain	5	5
Cardiac Perforation	5	5
Rupture	5	5
Chest Pain	5	5
Stenosis	5	5
Thromboembolism	5	5
Obstruction/Occlusion	4	4
Infarction, Cerebral	4	4
Heart Failure	4	4
Thrombosis	4	4
Blood Loss	4	4
Pseudoaneurysm	3	3
Ventricular Tachycardia	3	3
Cardiopulmonary Arrest	3	3
Edema	3	3
Embolus	3	3
Unspecified Infection	3	3
Heart Failure/Congestive Heart Failure	3	3
Tricuspid Valve Insufficiency/ Regurgitation	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pancreatitis	2	2
Anemia	2	2
Great Vessel Perforation	2	2
Loss of consciousness	2	2
Nausea	2	2
Sepsis	2	2
Shock	2	2
Ventricular Fibrillation	2	2
Tachycardia	1	1
Paralysis	1	1
Paresis	1	1
Reocclusion	1	1
Irritability	1	1
Cardiogenic Shock	1	1
Diminished Pulse Pressure	1	1
Weakness	1	1
Aneurysm	1	1
Arrhythmia	1	1
Atrial Fibrillation	1	1
Abdominal Pain	1	1
Adhesion(s)	1	1
Air Embolism	1	1
Airway Obstruction	1	1
Calcium Deposits/Calcification	1	1
Dyspnea	1	1
Failure of Implant	1	1
High Blood Pressure/ Hypertension	1	1
Emotional Changes	1	1
Cardiac Enzyme Elevation	1	1
Exsanguination	1	1
Fistula	1	1
Hemolysis	1	1
Chest Tightness/Pressure	1	1
Atrial Perforation	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Applied Medical Resources Corp	I	May-07-2020
2	Arrow International Inc	I	Nov-18-2021
3	Edwards Lifesciences, LLC	II	Nov-06-2023
4	Edwards Lifesciences, LLC	II	Oct-28-2022
5	INARI MEDICAL	II	Jun-09-2020
6	LeMaitre Vascular, Inc.	II	Nov-11-2022
7	LeMaitre Vascular, Inc.	I	Apr-01-2020