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	0

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4495	4515
Leak/Splash	3170	3171
Insufficient Information	1604	1604
Patient-Device Incompatibility	1330	1330
Malposition of Device	939	939
Migration	642	642
Fluid/Blood Leak	601	601
Material Puncture/Hole	584	584
Material Deformation	555	555
Migration or Expulsion of Device	460	460
Activation, Positioning or Separation Problem	450	450
Off-Label Use	423	423
Obstruction of Flow	420	420
Detachment of Device or Device Component	368	368
Lack of Effect	335	335
Improper or Incorrect Procedure or Method	333	333
Patient Device Interaction Problem	328	328
Appropriate Term/Code Not Available	312	312
Device-Device Incompatibility	237	237
Material Integrity Problem	220	220
Fracture	220	220
Device Dislodged or Dislocated	218	218
Difficult to Remove	211	211
Positioning Problem	198	198
Use of Device Problem	197	197
Deformation Due to Compressive Stress	184	184
Complete Blockage	184	184
Failure to Seal	180	180
Separation Problem	167	167
Activation Failure	129	129
Material Separation	126	126
Partial Blockage	124	124
Failure to Advance	122	122
Unintended Movement	119	119
Device Damaged by Another Device	113	113
Difficult to Advance	111	111
Physical Resistance/Sticking	109	109
Difficult or Delayed Positioning	94	94
Break	92	92
Difficult to Insert	88	88
Device Stenosis	75	75
Difficult or Delayed Separation	75	75
Positioning Failure	72	72
Inadequacy of Device Shape and/or Size	70	70
Difficult or Delayed Activation	68	68
Material Twisted/Bent	68	68
Defective Component	60	60
No Apparent Adverse Event	58	58
Mechanical Jam	52	52
Retraction Problem	49	49

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2987	2988
Aneurysm	2784	2784
Insufficient Information	2040	2040
Obstruction/Occlusion	1516	1516
Failure of Implant	1468	1468
Vascular Dissection	1092	1092
Rupture	860	860
Thrombosis/Thrombus	609	609
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	558	558
Pain	496	496
Hemorrhage/Bleeding	442	442
Ischemia	435	449
No Consequences Or Impact To Patient	402	402
Ruptured Aneurysm	402	402
Unspecified Infection	344	344
Injury	328	342
Stroke/CVA	327	327
Renal Failure	288	288
No Code Available	283	283
Occlusion	269	283
Death	237	241
Perforation of Vessels	193	193
Stenosis	178	178
Hematoma	174	176
Low Blood Pressure/ Hypotension	166	166
No Known Impact Or Consequence To Patient	153	153
Cardiac Arrest	145	145
Myocardial Infarction	134	134
Fistula	122	122
Abdominal Pain	120	120
Pseudoaneurysm	104	104
Embolism/Embolus	100	100
Paraplegia	99	99
Paralysis	91	91
Pneumonia	90	104
Respiratory Failure	86	100
Intimal Dissection	74	88
Bacterial Infection	69	69
Thrombus	65	65
Foreign Body In Patient	61	61
Fever	61	61
Chest Pain	57	57
Sepsis	52	52
Multiple Organ Failure	44	44
Anemia	43	43
Blood Loss	42	42
Heart Failure/Congestive Heart Failure	40	40
Thromboembolism	38	38
Perforation	37	37
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