TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
44	50	49	50	62	50

MDR Year	MDR Reports	MDR Events
2020	3057	3075
2021	3686	3689
2022	3455	3460
2023	3562	3562
2024	3320	3320
2025	2761	2761

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5302	5322
Leak/Splash	3469	3472
Insufficient Information	1736	1736
Patient-Device Incompatibility	1585	1585
Malposition of Device	1097	1097
Migration	782	782
Material Puncture/Hole	669	669
Material Deformation	668	668
Fluid/Blood Leak	635	635
Activation, Positioning or Separation Problem	530	530
Migration or Expulsion of Device	525	525
Off-Label Use	524	524
Obstruction of Flow	491	491
Detachment of Device or Device Component	431	431
Lack of Effect	420	420
Patient Device Interaction Problem	411	411
Improper or Incorrect Procedure or Method	354	354
Appropriate Term/Code Not Available	328	328
Positioning Problem	268	268
Device-Device Incompatibility	263	263
Fracture	250	250
Difficult to Remove	246	246
Failure to Seal	243	243
Device Dislodged or Dislocated	238	238
Material Integrity Problem	227	227
Deformation Due to Compressive Stress	219	219
Use of Device Problem	207	207
Complete Blockage	194	194
Separation Problem	187	187
Activation Failure	177	177
Failure to Advance	155	155
Material Separation	147	147
Difficult to Advance	144	144
Unintended Movement	131	131
Partial Blockage	126	126
Device Damaged by Another Device	123	123
Break	114	114
Physical Resistance/Sticking	111	111
Difficult to Insert	105	105
Device Stenosis	102	102
Difficult or Delayed Separation	98	98
Difficult or Delayed Positioning	98	98
Positioning Failure	85	85
No Apparent Adverse Event	84	84
Defective Component	81	81
Inadequacy of Device Shape and/or Size	80	80
Difficult or Delayed Activation	79	79
Material Twisted/Bent	77	77
Retraction Problem	62	62
Mechanical Jam	59	59

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3587	3588
Aneurysm	2948	2948
Insufficient Information	2302	2302
Obstruction/Occlusion	1809	1809
Failure of Implant	1478	1479
Vascular Dissection	1282	1282
Rupture	962	962
Thrombosis/Thrombus	724	724
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	579	579
Pain	552	552
Ischemia	543	557
Hemorrhage/Bleeding	522	524
Ruptured Aneurysm	462	462
Unspecified Infection	444	446
No Consequences Or Impact To Patient	402	402
Stroke/CVA	398	398
Renal Failure	345	345
Injury	328	342
No Code Available	283	283
Occlusion	269	283
Perforation of Vessels	246	246
Death	237	241
Stenosis	219	220
Hematoma	200	202
Low Blood Pressure/ Hypotension	185	185
Myocardial Infarction	168	168
Cardiac Arrest	166	166
No Known Impact Or Consequence To Patient	153	153
Fistula	147	147
Abdominal Pain	138	138
Embolism/Embolus	137	137
Pseudoaneurysm	131	131
Paraplegia	131	131
Pneumonia	123	137
Paralysis	122	122
Respiratory Failure	107	121
Foreign Body In Patient	81	81
Bacterial Infection	80	80
Fever	76	76
Intimal Dissection	74	88
Chest Pain	66	67
Thrombus	65	65
Multiple Organ Failure	63	63
Sepsis	63	65
Anemia	47	47
Heart Failure/Congestive Heart Failure	45	45
Perforation	44	44
Blood Loss	42	42
Thromboembolism	41	41
Unspecified Vascular Problem	39	39

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 Inc.	II	Sep-12-2020
5	Cook Inc.	II	Jul-10-2020
6	Cook Inc.	II	Jan-31-2020
7	Cook Medical Incorporated	I	Oct-10-2025
8	Endologix, Inc.	I	Jun-11-2020
9	Medtronic Vascular, Inc.	II	Feb-18-2022
10	Medtronic Vascular, Inc.	II	Nov-24-2021
11	Medtronic Vascular, Inc.	II	Jul-23-2021
12	Medtronic Vascular, Inc.	II	Jun-28-2021
13	Medtronic Vascular, Inc.	I	Mar-10-2021
14	W L Gore & Associates, Inc.	II	Oct-23-2020
15	W L Gore & Associates, Inc.	II	Oct-23-2020
16	W L Gore & Associates, Inc.	II	May-20-2020
17	W. L. Gore & Associates Inc.	II	Feb-04-2020