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	50	17

MDR Year	MDR Reports	MDR Events
2021	3686	3689
2022	3455	3461
2023	3562	3562
2024	3320	3320
2025	3346	3346
2026	1041	1041

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5032	5034
Leak/Splash	3008	3011
Patient-Device Incompatibility	1470	1471
Insufficient Information	1441	1441
Malposition of Device	1053	1053
Migration	772	772
Material Deformation	665	665
Fluid/Blood Leak	612	612
Material Puncture/Hole	567	567
Off-Label Use	549	549
Obstruction of Flow	509	509
Activation, Positioning or Separation Problem	462	462
Lack of Effect	451	451
Detachment of Device or Device Component	441	441
Migration or Expulsion of Device	436	436
Patient Device Interaction Problem	402	403
Appropriate Term/Code Not Available	290	290
Positioning Problem	290	290
Failure to Seal	256	256
Improper or Incorrect Procedure or Method	252	252
Fracture	240	240
Device-Device Incompatibility	233	233
Difficult to Remove	230	230
Device Dislodged or Dislocated	214	214
Deformation Due to Compressive Stress	199	199
Activation Failure	178	178
Material Separation	158	158
Complete Blockage	149	149
Separation Problem	147	147
Material Integrity Problem	142	142
Difficult to Advance	139	139
Failure to Advance	133	133
Device Stenosis	119	119
Unintended Movement	116	116
Device Damaged by Another Device	114	114
Break	113	113
Difficult or Delayed Separation	106	106
Use of Device Problem	102	102
No Apparent Adverse Event	95	95
Physical Resistance/Sticking	93	93
Partial Blockage	93	93
Difficult to Insert	90	90
Defective Component	78	78
Material Twisted/Bent	75	75
Positioning Failure	73	73
Retraction Problem	71	71
Difficult or Delayed Activation	67	67
Inadequacy of Device Shape and/or Size	64	64
Difficult or Delayed Positioning	59	59
Mechanical Jam	57	57

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3814	3815
Insufficient Information	2383	2383
Aneurysm	2347	2347
Obstruction/Occlusion	1916	1916
Vascular Dissection	1308	1309
Failure of Implant	1054	1055
Rupture	816	816
Thrombosis/Thrombus	773	773
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	570	570
Ischemia	537	537
Hemorrhage/Bleeding	504	506
Ruptured Aneurysm	484	484
Pain	464	464
Unspecified Infection	419	421
Stroke/CVA	398	398
Renal Failure	330	330
Perforation of Vessels	251	251
Stenosis	220	221
Hematoma	187	189
Myocardial Infarction	166	166
Low Blood Pressure/ Hypotension	156	156
Cardiac Arrest	153	153
Embolism/Embolus	150	150
Fistula	142	142
Paralysis	137	137
Abdominal Pain	134	134
Pseudoaneurysm	134	134
Paraplegia	130	130
Pneumonia	111	111
Respiratory Failure	105	105
Foreign Body In Patient	83	83
Bacterial Infection	81	81
Fever	75	75
Multiple Organ Failure	70	70
Chest Pain	64	65
Sepsis	56	58
Heart Failure/Congestive Heart Failure	47	47
Thromboembolism	46	46
Anemia	43	43
Renal Impairment	43	43
Paresis	40	40
Unspecified Vascular Problem	38	38
No Code Available	36	36
Inflammation	36	36
Shock	36	36
Perforation	31	31
Ischemia Stroke	30	30
High Blood Pressure/ Hypertension	29	29
Arrhythmia	29	31
Dyspnea	29	29

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