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2026 data FDA MAUDE openFDA

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

#54 of 1000 · 70,468 reports · 1994–2026

  • BOOK 70,468 reports
  • RANK #54 of 1000
  • DEATH 7,020 death-typed
  • INJ 52,795 injury-typed
  • MALF 10,365 malfunction
  • SPAN 1994–2026
  • PEAK 2015: 4,471
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (705 report gap)

System, Endovascular Graft, Aortic Aneurysm Treatment sits #54 of 1000 among tracked device types with 70,468 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 10.0% corpus 1.5% · above corpus mean (+8.4 pp)
  • INJ 74.9% corpus 30.4% · above corpus mean (+44.5 pp)
  • MALF 14.7% corpus 64.5% · below corpus mean (-49.8 pp)

Lead product-problem code Leak/Splash is 26% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 48% 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 70,468 MAUDE reports, ranked #54 of 1000.

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

Event Types

Injury 52,795 (74.9%)
Malfunction 10,365 (14.7%)
Death 7,020 (10.0%)
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 35,848 (41.7%)
10,974 (12.8%)
R 10,388 (12.1%)
Other 7,834 (9.1%)
Hospitalization 7,796 (9.1%)
Death 6,842 (8.0%)
O 2,909 (3.4%)
H 1,128 (1.3%)
Life Threatening 870 (1.0%)
L 461 (0.5%)
S 336 (0.4%)
D 280 (0.3%)
Disability 230 (0.3%)
Congenital Anomaly 33 (0.0%)
C 1 (0.0%)

Top Product Problems

Leak/Splash 10,122
Adverse Event Without Identified Device or Use Problem 8,670
Insufficient Information 2,875
Patient-Device Incompatibility 2,263
Malposition of Device 1,891
Migration or Expulsion of Device 1,522
Material Puncture/Hole 1,117
Failure To Adhere Or Bond 1,091
Activation, Positioning or Separation Problem 955
Migration 946
Fluid/Blood Leak 922
Material Deformation 875
Occlusion Within Device 792
Material Integrity Problem 754
Off-Label Use 735
Improper or Incorrect Procedure or Method 661
Endoleaks 649
Obstruction of Flow 641
Detachment of Device or Device Component 608
Hole In Material 608

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: 3,795
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: 500

Related Entities for System, Endovascular Graft, Aortic Aneurysm Treatment

Top Manufacturers

MEDTRONIC IRELAND 21,681
W.L. GORE & ASSOCIATES 8,185
W. L. GORE & ASSOCIATES, INC. 7,799
MEDTRONIC CARDIOVASCULAR 3,617
COOK, INC. 2,598
COOK INC 1,703

Event Locations

39,821 (56.5%)
I 23,743 (33.7%)
HOSPITAL 5,303 (7.5%)
UNKNOWN 1,308 (1.9%)
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 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (70,468 here).

Prosthesis 69,763 Set 71,401 Cabinet, Table And Tray, Anesthesia 71,750 Aortic Valve 72,550

Similar death-typed counts

Nearest other device types by death-typed report count (7,020 here), distinct from the volume row.

Drug Eluting Permanent Right Ventricular Or… 4,956 Permanent Pacemaker Electrode 9,301 Defibrillator 4,732 Temporary Non-Roller Type Left Heart Suppor… 4,677

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.