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	51

MDR Year	MDR Reports	MDR Events
2019	3592	3619
2020	3057	3075
2021	3686	3689
2022	3455	3455
2023	3562	3562
2024	2410	2410

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5132	5179
Leak/Splash	3779	3780
Insufficient Information	2086	2086
Patient-Device Incompatibility	1438	1438
Malposition of Device	1038	1038
Material Puncture/Hole	796	796
Migration	698	698
Fluid/Blood Leak	681	681
Material Deformation	581	581
Migration or Expulsion of Device	554	554
Activation, Positioning or Separation Problem	511	511
Improper or Incorrect Procedure or Method	450	450
Obstruction of Flow	448	448
Material Integrity Problem	439	439
Off-Label Use	415	415
Detachment of Device or Device Component	408	408
Appropriate Term/Code Not Available	404	404
Patient Device Interaction Problem	353	353
Use of Device Problem	322	322
Lack of Effect	308	308
Device Dislodged or Dislocated	251	251
Difficult to Remove	247	247
Deformation Due to Compressive Stress	244	244
Device-Device Incompatibility	240	240
Fracture	240	240
Complete Blockage	224	224
Positioning Problem	200	200
Separation Problem	182	182
Failure to Seal	155	155
Unintended Movement	151	151
Failure to Advance	147	147
Activation Failure	142	142
Device Damaged by Another Device	138	138
Partial Blockage	132	132
Material Separation	132	132
Difficult or Delayed Positioning	127	127
Physical Resistance/Sticking	115	115
Difficult to Advance	110	110
Difficult to Insert	102	102
Break	99	99
Product Quality Problem	87	87
Inadequacy of Device Shape and/or Size	86	86
Difficult or Delayed Activation	82	82
Material Twisted/Bent	74	74
Positioning Failure	72	72
Difficult or Delayed Separation	67	67
Device Stenosis	67	67
Defective Component	66	66
Microbial Contamination of Device	61	61
No Apparent Adverse Event	58	58

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Aneurysm	3450	3450
No Clinical Signs, Symptoms or Conditions	2762	2763
Failure of Implant	2095	2095
Insufficient Information	1952	1952
Obstruction/Occlusion	1429	1429
Vascular Dissection	1096	1096
Rupture	1008	1008
No Consequences Or Impact To Patient	891	891
Injury	769	785
Pain	606	606
Occlusion	582	614
Thrombosis/Thrombus	566	566
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	557	557
No Code Available	554	554
Death	518	531
Ischemia	463	493
Hemorrhage/Bleeding	454	454
Unspecified Infection	415	415
Ruptured Aneurysm	386	386
Stroke/CVA	337	353
No Known Impact Or Consequence To Patient	326	326
Renal Failure	316	332
Low Blood Pressure/ Hypotension	246	246
Perforation of Vessels	210	212
Stenosis	195	195
Thrombus	183	183
Hematoma	182	184
Intimal Dissection	164	194
Cardiac Arrest	147	147
Abdominal Pain	138	138
Myocardial Infarction	137	153
Fistula	133	133
Pseudoaneurysm	111	111
Paralysis	107	107
Paraplegia	103	103
Pneumonia	102	132
Embolism/Embolus	95	95
Blood Loss	89	89
Respiratory Failure	88	118
Aortic Dissection	86	86
Thrombosis	75	75
Bacterial Infection	75	75
Chest Pain	73	73
No Information	67	67
Fever	65	65
Sepsis	63	63
Foreign Body In Patient	61	61
Multiple Organ Failure	55	55
Embolism	53	83
Anemia	51	51

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