PlainHospital
2025 data FDA MAUDE openFDA

Stent, Metallic, Expandable, Duodenal

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Stent, Metallic, Expandable, Duodenal LIGHT-BOOK · MAUDE

#661 of 1000 · 984 reports · 2005–2025

  • BOOK 984 reports
  • RANK #661 of 1000
  • DEATH 55 death-typed
  • INJ 427 injury-typed
  • MALF 499 malfunction
  • SPAN 2005–2025
  • PEAK 2010: 102
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous (0 report gap)

Stent, Metallic, Expandable, Duodenal sits #661 of 1000 among tracked device types with 984 MAUDE reports spanning 2005–2025. 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 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 43.4% corpus 30.4% · above corpus mean (+13.0 pp)
  • MALF 50.7% corpus 64.5% · below corpus mean (-13.8 pp)

Lead product-problem code Break is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 53% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Stent, Metallic, Expandable, Duodenal in the event-volume neighbourhood

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

reports

What this shows Stent, Metallic, Expandable, Duodenal carries 984 MAUDE reports, ranked #661 of 1000.

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

Event Types

Malfunction 499 (50.7%)
Injury 427 (43.4%)
Death 55 (5.6%)
2 (0.2%)
Other 1 (0.1%)

Patient Outcomes

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

488 (48.1%)
Required Intervention 298 (29.4%)
Hospitalization 89 (8.8%)
Death 54 (5.3%)
Other 53 (5.2%)
R 18 (1.8%)
O 10 (1.0%)
H 3 (0.3%)
D 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Break 103
Fracture 77
Adverse Event Without Identified Device or Use Problem 74
Activation, Positioning or Separation Problem 50
Migration 48
Activation Failure 39
Migration or Expulsion of Device 32
Positioning Problem 29
Material Deformation 27
Premature Activation 25
Delivery System Failure 21
Positioning Failure 18
Partial Blockage 15
Difficult to Remove 12
Insufficient Information 12
Improper or Incorrect Procedure or Method 11
Appropriate Term/Code Not Available 9
Detachment of Device or Device Component 9
Material Twisted/Bent 9
Device Stenosis 6

Yearly Trend

05
2005: 1
06
2006: 6
07
2007: 14
08
2008: 25
09
2009: 92
10
2010: 102
11
2011: 58
12
2012: 71
13
2013: 62
14
2014: 43
15
2015: 51
16
2016: 41
17
2017: 85
18
2018: 49
19
2019: 35
20
2020: 32
21
2021: 70
22
2022: 28
23
2023: 53
24
2024: 34
25
2025: 32

Related Entities for Stent, Metallic, Expandable, Duodenal

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 412
COOK IRELAND LTD 200
BOSTON SCIENTIFIC CORPORATION 137
BOSTON SCIENTIFIC 20
BOSTON SCIENTIFIC CORP 12

Event Locations

573 (58.2%)
HOSPITAL 206 (20.9%)
I 198 (20.1%)
NO INFORMATION 6 (0.6%)
HOME 1 (0.1%)

Compare BOSTON SCIENTIFIC - GALWAY vs COOK IRELAND LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Metallic, Expandable, Duodenal, 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 (984 here).

Prosthesis 984 Pack, Hot Or Cold, Water Circulating 983 Container, Sharps 977 Filter, Bacterial, Breathing-Circuit 977

Similar death-typed counts

Nearest other device types by death-typed report count (55 here), distinct from the volume row.

Bottle, Collection, Vacuum 55 Catheter, Balloon Type 55 Orthopedic Manual Surgical Instrument 55 Occluder, Patent Ductus, Arteriosus 54

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

Disclaimer: MAUDE figures for Stent, Metallic, Expandable, Duodenal 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 Stent, Metallic, Expandable, Duodenal; 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.