TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
34	44	50	49	50	41

MDR Year	MDR Reports	MDR Events
2019	3592	3619
2020	3057	3075
2021	3686	3689
2022	3455	3455
2023	3562	3562
2024	2197	2197

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5075	5122
Leak/Splash	3745	3746
Insufficient Information	2079	2079
Patient-Device Incompatibility	1410	1410
Malposition of Device	1026	1026
Material Puncture/Hole	787	787
Migration	692	692
Fluid/Blood Leak	671	671
Material Deformation	575	575
Migration or Expulsion of Device	547	547
Activation, Positioning or Separation Problem	505	505
Improper or Incorrect Procedure or Method	448	448
Material Integrity Problem	439	439
Obstruction of Flow	438	438
Detachment of Device or Device Component	405	405
Off-Label Use	404	404
Appropriate Term/Code Not Available	403	403
Patient Device Interaction Problem	345	345
Use of Device Problem	321	321
Lack of Effect	303	303
Device Dislodged or Dislocated	249	249
Difficult to Remove	242	242
Deformation Due to Compressive Stress	241	241
Fracture	237	237
Device-Device Incompatibility	231	231
Complete Blockage	222	222
Positioning Problem	198	198
Separation Problem	181	181
Failure to Seal	155	155
Unintended Movement	149	149
Activation Failure	142	142
Failure to Advance	141	141
Device Damaged by Another Device	138	138
Material Separation	131	131
Partial Blockage	131	131
Difficult or Delayed Positioning	127	127
Physical Resistance/Sticking	115	115
Difficult to Advance	107	107
Difficult to Insert	100	100
Break	97	97
Product Quality Problem	87	87
Inadequacy of Device Shape and/or Size	86	86
Difficult or Delayed Activation	81	81
Material Twisted/Bent	73	73
Positioning Failure	70	70
Device Stenosis	67	67
Difficult or Delayed Separation	65	65
Defective Component	65	65
Microbial Contamination of Device	61	61
No Apparent Adverse Event	57	57

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Aneurysm	3434	3434
No Clinical Signs, Symptoms or Conditions	2706	2707
Failure of Implant	2095	2095
Insufficient Information	1925	1925
Obstruction/Occlusion	1408	1408
Vascular Dissection	1076	1076
Rupture	996	996
No Consequences Or Impact To Patient	891	891
Injury	769	785
Pain	600	600
Occlusion	582	614
No Code Available	554	554
Thrombosis/Thrombus	554	554
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	554	554
Death	518	531
Ischemia	458	488
Hemorrhage/Bleeding	454	454
Unspecified Infection	408	408
Ruptured Aneurysm	381	381
Stroke/CVA	337	353
No Known Impact Or Consequence To Patient	326	326
Renal Failure	312	328
Low Blood Pressure/ Hypotension	245	245
Perforation of Vessels	207	209
Stenosis	193	193
Thrombus	183	183
Hematoma	181	183
Intimal Dissection	164	194
Cardiac Arrest	147	147
Myocardial Infarction	135	151
Abdominal Pain	134	134
Fistula	129	129
Pseudoaneurysm	111	111
Paralysis	105	105
Paraplegia	102	102
Pneumonia	102	132
Embolism/Embolus	91	91
Blood Loss	89	89
Aortic Dissection	86	86
Respiratory Failure	83	113
Thrombosis	75	75
Bacterial Infection	74	74
Chest Pain	72	72
No Information	67	67
Fever	64	64
Sepsis	62	62
Foreign Body In Patient	61	61
Embolism	53	83
Multiple Organ Failure	50	50
Anemia	49	49

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 Inc.	II	Jun-19-2019
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