2026 data FDA MAUDE openFDA

Stents, Drains And Dilators For The Biliary Ducts

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 MAUDE casebook

openFDA event book Stents MID-BOOK · MAUDE

#100 of 1000 · 32,811 reports · 1993–2026

  • BOOK 32,811 reports
  • RANK #100 of 1000
  • DEATH 355 death-typed
  • INJ 9,660 injury-typed
  • MALF 22,493 malfunction
  • SPAN 1993–2026
  • PEAK 2021: 2,297
  • PHOTO Wire, Guide, Catheter

Nearest event-volume peer: Wire, Guide, Catheter (12 report gap)

Stents, Drains And Dilators For The Biliary Ducts sits #100 of 1000 among tracked device types with 32,811 MAUDE reports spanning 1993–2026. 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 1.1% corpus 1.5% · near corpus mean (-0.4 pp)
  • INJ 29.4% corpus 30.4% · below corpus mean (-1.0 pp)
  • MALF 68.6% corpus 64.5% · above corpus mean (+4.0 pp)

Lead product-problem code Material Rupture is 22% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 39% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Stents in the event-volume neighbourhood

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

reports

What this shows Stents, Drains And Dilators For The Biliary Ducts carries 32,811 MAUDE reports, ranked #100 of 1000.

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

Event Types

Malfunction 22,493 (68.6%)
Injury 9,660 (29.4%)
Death 355 (1.1%)
Other 255 (0.8%)
48 (0.1%)

Patient Outcomes

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

22,349 (64.2%)
Required Intervention 7,169 (20.6%)
Other 1,354 (3.9%)
R 1,241 (3.6%)
Hospitalization 1,161 (3.3%)
L 382 (1.1%)
Death 363 (1.0%)
Life Threatening 316 (0.9%)
S 155 (0.4%)
O 117 (0.3%)
H 112 (0.3%)
Disability 59 (0.2%)
D 12 (0.0%)
Congenital Anomaly 10 (0.0%)
C 1 (0.0%)

Top Product Problems

Material Rupture 4,008
Break 2,027
Adverse Event Without Identified Device or Use Problem 1,638
Improper or Incorrect Procedure or Method 1,101
Material Deformation 1,033
Material Puncture/Hole 946
Burst Container or Vessel 878
Detachment of Device or Device Component 783
Difficult to Remove 734
Device Dislodged or Dislocated 644
Off-Label Use 633
Activation, Positioning or Separation Problem 623
Migration 473
Positioning Failure 463
Use of Device Problem 458
Leak/Splash 448
Fracture 414
Difficult to Advance 412
Activation Failure 368
Material Twisted/Bent 363

Yearly Trend

93
1993: 1
94
1994: 2
95
1995: 6
96
1996: 27
97
1997: 87
98
1998: 89
99
1999: 73
00
2000: 67
01
2001: 119
02
2002: 172
03
2003: 272
04
2004: 440
05
2005: 373
06
2006: 587
07
2007: 1,006
08
2008: 1,465
09
2009: 1,654
10
2010: 1,433
11
2011: 1,321
12
2012: 1,183
13
2013: 1,060
14
2014: 1,269
15
2015: 1,543
16
2016: 1,452
17
2017: 1,515
18
2018: 1,681
19
2019: 1,896
20
2020: 2,182
21
2021: 2,297
22
2022: 1,749
23
2023: 1,615
24
2024: 1,948
25
2025: 1,944
26
2026: 283

Related Entities for Stents, Drains And Dilators For The Biliary Ducts

Event Locations

17,118 (52.2%)
I 9,398 (28.6%)
HOSPITAL 5,335 (16.3%)
OTHER 551 (1.7%)
UNKNOWN 248 (0.8%)
NO INFORMATION 106 (0.3%)
NOT APPLICABLE 17 (0.1%)
OUTPATIENT TREATMENT FACILITY 12 (0.0%)
HOME 8 (0.0%)
AMBULATORY SURGICAL FACILITY 7 (0.0%)
INVALID DATA 5 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 4 (0.0%)
NURSING HOME 2 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - GALWAY →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stents, 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 (32,811 here).

Similar death-typed counts

Nearest other device types by death-typed report count (355 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stents 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 Stents; 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.