PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §878.3610 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#666 of 1000 · 991 reports · 2005–2026

  • BOOK 991 reports
  • RANK #666 of 1000
  • DEATH 55 death-typed
  • INJ 428 injury-typed
  • MALF 505 malfunction
  • SPAN 2005–2026
  • PEAK 2010: 102
  • PHOTO Mixer

Nearest event-volume peer: Mixer, Cement, For Clinical Use (7 report gap)

Stent, Metallic, Expandable, Duodenal sits #666 of 1000 among tracked device types with 991 MAUDE reports spanning 2005–2026. 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

Stent, Metallic, Expandable, Duodenal carries 51.0% MALFUNCTION-coded reports, 13.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.5% corpus 1.5% · above corpus mean (+4.0 pp)
  • INJ 43.2% corpus 30.3% · above corpus mean (+12.9 pp)
  • MALF 51.0% corpus 64.8% · below corpus mean (-13.9 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 52% 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 991 MAUDE reports, ranked #666 of 1000.

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

Event Types

Malfunction 505 (51.0%)
Injury 428 (43.2%)
Death 55 (5.5%)
2 (0.2%)
Other 1 (0.1%)

Patient Outcomes

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

492 (48.2%)
Required Intervention 299 (29.3%)
Hospitalization 89 (8.7%)
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 171
Activation, Positioning or Separation Problem 137
Adverse Event Without Identified Device or Use Problem 123
Fracture 103
Positioning Failure 71
Positioning Problem 61
Activation Failure 59
Migration or Expulsion of Device 53
Appropriate Device Problem Term/Code Not Available 51
Migration 49
Other (for use when an appropriate device code cannot be identified) 45
Premature Activation 38
Partial Blockage 34
Delamination 32
Material Deformation 31
Difficult to Remove 25
Obstruction of Flow 24
Delivery System Failure 22
Difficult or Delayed Positioning 21
Insufficient Device Problem Information 20

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
26
2026: 7

Reports in 2025 (32) held close to the prior two-year average of 44.

Related Entities for Stent, Metallic, Expandable, Duodenal

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 412
COOK IRELAND LTD 202
BOSTON SCIENTIFIC CORPORATION 140
BOSTON SCIENTIFIC 20
BOSTON SCIENTIFIC CORP 12

Event Locations

578 (58.3%)
HOSPITAL 208 (21.0%)
I 198 (20.0%)
NO INFORMATION 6 (0.6%)
HOME 1 (0.1%)

Compare BOSTON SCIENTIFIC - GALWAY vs COOK IRELAND LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Metallic, Expandable, Duodenal: 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 (991 here).

Mixer, Cement, For Clinical Use 998 Pack, Hot Or Cold, Water Circulating 984 Midline Catheter 983 Hepatitis A Test 982

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 Wheelchair, Mechanical 55

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.