TPLC - Total Product Life Cycle

• Device: system, endovascular graft, aortic aneurysm treatment
• Product Code: MIH
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
50	49	50	62	51	0

MDR Year	MDR Reports	MDR Events
2021	3686	3689
2022	3455	3461
2023	3562	3562
2024	3320	3320
2025	3347	3347

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4704	4706
Leak/Splash	2903	2906
Insufficient Information	1405	1405
Patient-Device Incompatibility	1369	1370
Malposition of Device	991	991
Migration	722	722
Material Deformation	629	629
Fluid/Blood Leak	587	587
Material Puncture/Hole	537	537
Off-Label Use	517	517
Obstruction of Flow	474	474
Activation, Positioning or Separation Problem	443	443
Lack of Effect	437	437
Migration or Expulsion of Device	429	429
Detachment of Device or Device Component	407	407
Patient Device Interaction Problem	390	391
Appropriate Term/Code Not Available	286	286
Positioning Problem	263	263
Failure to Seal	245	245
Improper or Incorrect Procedure or Method	242	242
Fracture	229	229
Device-Device Incompatibility	224	224
Device Dislodged or Dislocated	207	207
Difficult to Remove	206	206
Deformation Due to Compressive Stress	187	187
Activation Failure	162	162
Complete Blockage	143	143
Separation Problem	140	140
Material Separation	137	137
Material Integrity Problem	137	137
Failure to Advance	132	132
Difficult to Advance	128	128
Device Stenosis	111	111
Unintended Movement	111	111
Break	108	108
Device Damaged by Another Device	101	101
Difficult or Delayed Separation	99	99
Use of Device Problem	99	99
Partial Blockage	93	93
Physical Resistance/Sticking	92	92
Difficult to Insert	85	85
No Apparent Adverse Event	83	83
Defective Component	76	76
Positioning Failure	72	72
Material Twisted/Bent	69	69
Difficult or Delayed Activation	63	63
Retraction Problem	62	62
Inadequacy of Device Shape and/or Size	60	60
Difficult or Delayed Positioning	56	56
Mechanical Jam	53	53

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3591	3592
Aneurysm	2291	2291
Insufficient Information	2269	2269
Obstruction/Occlusion	1820	1820
Vascular Dissection	1237	1238
Failure of Implant	1051	1052
Rupture	795	795
Thrombosis/Thrombus	723	723
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	566	566
Ischemia	502	502
Hemorrhage/Bleeding	489	491
Ruptured Aneurysm	465	465
Pain	450	450
Unspecified Infection	388	390
Stroke/CVA	360	360
Renal Failure	309	309
Perforation of Vessels	228	228
Stenosis	208	209
Hematoma	178	180
Myocardial Infarction	150	150
Cardiac Arrest	147	147
Embolism/Embolus	139	139
Low Blood Pressure/ Hypotension	138	138
Fistula	136	136
Abdominal Pain	131	131
Pseudoaneurysm	124	124
Paralysis	124	124
Paraplegia	117	117
Pneumonia	105	105
Respiratory Failure	91	91
Foreign Body In Patient	78	78
Bacterial Infection	74	74
Fever	70	70
Chest Pain	64	65
Multiple Organ Failure	61	61
Sepsis	54	56
Heart Failure/Congestive Heart Failure	47	47
Anemia	40	40
Thromboembolism	38	38
No Code Available	36	36
Renal Impairment	36	36
Unspecified Vascular Problem	36	36
Paresis	35	35
Inflammation	34	34
Shock	31	31
Perforation	30	30
Arrhythmia	29	31
Foreign Body Embolism	28	28
Dyspnea	28	28
Muscle Weakness	28	28

Recalls
Manufacturer		Recall Class	Date Posted
1	Bolton Medical Inc.	II	Mar-27-2024
2	Bolton Medical Inc.	II	Jun-06-2023
3	Bolton Medical Inc.	II	Jan-19-2023
4	Cook Medical Incorporated	I	Oct-10-2025
5	Medtronic Vascular, Inc.	II	Feb-18-2022
6	Medtronic Vascular, Inc.	II	Nov-24-2021
7	Medtronic Vascular, Inc.	II	Jul-23-2021
8	Medtronic Vascular, Inc.	II	Jun-28-2021
9	Medtronic Vascular, Inc.	I	Mar-10-2021