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2026 data FDA MAUDE openFDA FDA Class III

System, Endovascular Graft, Aortic Aneurysm Treatment

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book System MID-BOOK · MAUDE

#56 of 1000 · 71,804 reports · 1994–2026

  • BOOK 71,804 reports
  • RANK #56 of 1000
  • DEATH 7,074 death-typed
  • INJ 53,807 injury-typed
  • MALF 10,635 malfunction
  • SPAN 1994–2026
  • PEAK 2015: 4,471
  • PHOTO Set

Nearest event-volume peer: Set, Administration, For Peritoneal Dialysis, Disposable (338 report gap)

System, Endovascular Graft, Aortic Aneurysm Treatment sits #56 of 1000 among tracked device types with 71,804 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

System carries 14.8% MALFUNCTION-coded reports, 50.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 9.9% corpus 1.5% · above corpus mean (+8.3 pp)
  • INJ 74.9% corpus 30.3% · above corpus mean (+44.6 pp)
  • MALF 14.8% corpus 64.8% · below corpus mean (-50.0 pp)

Lead product-problem code Leak/Splash is 34% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 47% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

System in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows System, Endovascular Graft, Aortic Aneurysm Treatment carries 71,804 MAUDE reports, ranked #56 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 53,807 (74.9%)
Malfunction 10,635 (14.8%)
Death 7,074 (9.9%)
Other 196 (0.3%)
92 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 36,337 (41.7%)
11,161 (12.8%)
R 10,457 (12.0%)
Other 7,997 (9.2%)
Hospitalization 7,854 (9.0%)
Death 6,888 (7.9%)
O 2,962 (3.4%)
H 1,178 (1.4%)
Life Threatening 874 (1.0%)
L 461 (0.5%)
S 337 (0.4%)
D 284 (0.3%)
Disability 231 (0.3%)
Congenital Anomaly 33 (0.0%)
C 1 (0.0%)

Top Product Problems

Leak/Splash 24,334
Adverse Event Without Identified Device or Use Problem 12,218
Insufficient Device Problem Information 4,592
Migration or Expulsion of Device 4,415
Occlusion Within Device 3,908
Malposition of Device 2,816
Device remains implanted 2,623
Patient-Device Incompatibility 2,449
Difficult to Remove 1,845
Failure To Adhere Or Bond 1,285
Fluid/Blood Leak 1,255
Activation, Positioning or Separation Problem 1,203
Kinked 1,190
Material Puncture/Hole 1,166
Difficult To Position 1,075
Explanted 1,040
Other (for use when an appropriate device code cannot be identified) 1,035
Migration 1,023
Difficult or Delayed Positioning 987
Material Deformation 982

Yearly Trend

94
1994: 1
97
1997: 2
98
1998: 4
99
1999: 15
00
2000: 146
01
2001: 1,195
02
2002: 634
03
2003: 720
04
2004: 1,098
05
2005: 821
06
2006: 937
07
2007: 1,323
08
2008: 1,745
09
2009: 2,600
10
2010: 2,492
11
2011: 3,240
12
2012: 3,787
13
2013: 3,883
14
2014: 4,249
15
2015: 4,471
16
2016: 4,296
17
2017: 4,105
18
2018: 4,178
19
2019: 3,592
20
2020: 3,057
21
2021: 3,686
22
2022: 3,455
23
2023: 3,562
24
2024: 3,320
25
2025: 3,346
26
2026: 1,844

Reports in 2025 (3,346) held close to the prior two-year average of 3,441.

Related Entities for System, Endovascular Graft, Aortic Aneurysm Treatment

Top Manufacturers

MEDTRONIC IRELAND 21,921
W. L. GORE & ASSOCIATES, INC. 8,450
W.L. GORE & ASSOCIATES 8,185
MEDTRONIC CARDIOVASCULAR 3,617
COOK, INC. 2,599
COOK INC 1,739

Event Locations

41,154 (57.3%)
I 23,737 (33.1%)
HOSPITAL 5,312 (7.4%)
UNKNOWN 1,308 (1.8%)
NO INFORMATION 143 (0.2%)
OTHER 80 (0.1%)
HOME 34 (0.0%)
NOT APPLICABLE 22 (0.0%)
OUTPATIENT TREATMENT FACILITY 5 (0.0%)
INVALID DATA 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare MEDTRONIC IRELAND vs W. L. GORE & ASSOCIATES, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (71,804 here).

Set 72,142 Prosthesis 70,458 Gastroscope And Accessories, Flexible/Rigid 73,278 Glucose Dehydrogenase, Glucose 74,205

Similar death-typed counts

Nearest other device types by death-typed report count (7,074 here), distinct from the volume row.

Aortic Valve 7,956 Temporary Non-Roller Type Left Heart Suppor… 5,667 Drug Eluting Permanent Right Ventricular Or… 5,055 Defibrillator 4,802

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for System are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.