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	6

MDR Year	MDR Reports	MDR Events
2020	3057	3075
2021	3686	3689
2022	3455	3455
2023	3562	3562
2024	3322	3322
2025	500	500

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4660	4680
Leak/Splash	3234	3235
Insufficient Information	1636	1636
Patient-Device Incompatibility	1371	1371
Malposition of Device	961	961
Migration	670	670
Fluid/Blood Leak	614	614
Material Puncture/Hole	594	594
Material Deformation	568	568
Migration or Expulsion of Device	475	475
Activation, Positioning or Separation Problem	462	462
Off-Label Use	447	447
Obstruction of Flow	431	431
Detachment of Device or Device Component	379	379
Lack of Effect	350	350
Patient Device Interaction Problem	337	337
Improper or Incorrect Procedure or Method	335	335
Appropriate Term/Code Not Available	315	315
Device-Device Incompatibility	243	243
Fracture	224	224
Material Integrity Problem	223	223
Device Dislodged or Dislocated	221	221
Difficult to Remove	218	218
Positioning Problem	208	208
Use of Device Problem	198	198
Failure to Seal	187	187
Deformation Due to Compressive Stress	186	186
Complete Blockage	186	186
Separation Problem	172	172
Activation Failure	135	135
Material Separation	131	131
Failure to Advance	130	130
Partial Blockage	124	124
Difficult to Advance	123	123
Unintended Movement	121	121
Device Damaged by Another Device	114	114
Physical Resistance/Sticking	109	109
Break	97	97
Difficult or Delayed Positioning	94	94
Difficult to Insert	92	92
Device Stenosis	79	79
Difficult or Delayed Separation	78	78
Positioning Failure	75	75
Inadequacy of Device Shape and/or Size	72	72
Difficult or Delayed Activation	68	68
Material Twisted/Bent	68	68
No Apparent Adverse Event	65	65
Defective Component	63	63
Mechanical Jam	52	52
Retraction Problem	51	51

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3112	3113
Aneurysm	2821	2821
Insufficient Information	2099	2099
Obstruction/Occlusion	1572	1572
Failure of Implant	1472	1472
Vascular Dissection	1126	1126
Rupture	877	877
Thrombosis/Thrombus	623	623
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	562	562
Pain	506	506
Hemorrhage/Bleeding	467	467
Ischemia	457	471
Ruptured Aneurysm	410	410
No Consequences Or Impact To Patient	402	402
Unspecified Infection	373	373
Stroke/CVA	342	342
Injury	328	342
Renal Failure	303	303
No Code Available	283	283
Occlusion	269	283
Death	237	241
Perforation of Vessels	201	201
Stenosis	188	188
Hematoma	181	183
Low Blood Pressure/ Hypotension	171	171
No Known Impact Or Consequence To Patient	153	153
Cardiac Arrest	150	150
Myocardial Infarction	146	146
Fistula	130	130
Abdominal Pain	123	123
Embolism/Embolus	109	109
Pseudoaneurysm	109	109
Paraplegia	106	106
Paralysis	96	96
Pneumonia	92	106
Respiratory Failure	89	103
Intimal Dissection	74	88
Bacterial Infection	70	70
Foreign Body In Patient	67	67
Thrombus	65	65
Fever	64	64
Chest Pain	59	59
Sepsis	52	52
Multiple Organ Failure	52	52
Anemia	43	43
Blood Loss	42	42
Heart Failure/Congestive Heart Failure	41	41
Thromboembolism	40	40
Perforation	39	39
Aortic Dissection	34	34

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	Endologix, Inc.	I	Jun-11-2020
8	Medtronic Vascular, Inc.	II	Feb-18-2022
9	Medtronic Vascular, Inc.	II	Nov-24-2021
10	Medtronic Vascular, Inc.	II	Jul-23-2021
11	Medtronic Vascular, Inc.	II	Jun-28-2021
12	Medtronic Vascular, Inc.	I	Mar-10-2021
13	W L Gore & Associates, Inc.	II	Oct-23-2020
14	W L Gore & Associates, Inc.	II	Oct-23-2020
15	W L Gore & Associates, Inc.	II	May-20-2020
16	W. L. Gore & Associates Inc.	II	Feb-04-2020