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2026 data FDA MAUDE openFDA

Stent, Colonic, Metallic, Expandable

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 Stent, Colonic, Metallic, Expandable LIGHT-BOOK · MAUDE

#584 of 1000 · 1,307 reports · 1997–2026

  • BOOK 1,307 reports
  • RANK #584 of 1000
  • DEATH 104 death-typed
  • INJ 621 injury-typed
  • MALF 580 malfunction
  • SPAN 1997–2026
  • PEAK 2009: 152
  • PHOTO Implant

Nearest event-volume peer: Implant, Hearing, Active, Middle Ear, Partially Implanted (9 report gap)

Stent, Colonic, Metallic, Expandable sits #584 of 1000 among tracked device types with 1,307 MAUDE reports spanning 1997–2026. 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 8.0% corpus 1.5% · above corpus mean (+6.4 pp)
  • INJ 47.5% corpus 30.4% · above corpus mean (+17.1 pp)
  • MALF 44.4% corpus 64.5% · below corpus mean (-20.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 14% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - GALWAY accounts for 48% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

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

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

reports

What this shows Stent, Colonic, Metallic, Expandable carries 1,307 MAUDE reports, ranked #584 of 1000.

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

Event Types

Injury 621 (47.5%)
Malfunction 580 (44.4%)
Death 104 (8.0%)
1 (0.1%)
Other 1 (0.1%)

Patient Outcomes

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

574 (40.9%)
Required Intervention 391 (27.9%)
Other 160 (11.4%)
Death 100 (7.1%)
Hospitalization 77 (5.5%)
R 69 (4.9%)
O 13 (0.9%)
H 6 (0.4%)
D 4 (0.3%)
L 4 (0.3%)
S 2 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 85
Activation, Positioning or Separation Problem 73
Activation Failure 56
Positioning Problem 55
Break 44
Material Deformation 44
Premature Activation 44
Difficult to Remove 31
Migration 27
Insufficient Information 23
Delivery System Failure 21
Positioning Failure 21
Migration or Expulsion of Device 17
Material Twisted/Bent 13
Use of Device Problem 13
Device Stenosis 12
Difficult or Delayed Positioning 10
Improper or Incorrect Procedure or Method 10
Difficult to Advance 9
Material Integrity Problem 8

Yearly Trend

97
1997: 1
98
1998: 5
99
1999: 1
00
2000: 1
01
2001: 2
02
2002: 2
03
2003: 3
04
2004: 7
05
2005: 3
06
2006: 25
07
2007: 30
08
2008: 144
09
2009: 152
10
2010: 71
11
2011: 40
12
2012: 104
13
2013: 100
14
2014: 70
15
2015: 72
16
2016: 56
17
2017: 49
18
2018: 44
19
2019: 42
20
2020: 46
21
2021: 56
22
2022: 35
23
2023: 38
24
2024: 70
25
2025: 29
26
2026: 9

Related Entities for Stent, Colonic, Metallic, Expandable

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 474
BOSTON SCIENTIFIC CORPORATION 258
COOK IRELAND LTD 152
BOSTON SCIENTIFIC 88
BOSTON SCIENTIFIC CORP 13

Event Locations

924 (70.7%)
I 206 (15.8%)
HOSPITAL 171 (13.1%)
NOT APPLICABLE 4 (0.3%)
NO INFORMATION 1 (0.1%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC - GALWAY vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Colonic, Metallic, Expandable, 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 (1,307 here).

Implant 1,298 Catheter For Crossing Total Occlusions 1,293 Intrauterine Tamponade Balloon 1,286 Fluid Jet Removal System 1,331

Similar death-typed counts

Nearest other device types by death-typed report count (104 here), distinct from the volume row.

Powered Laser Surgical Instrument 104 Separator 105 Stretcher, Wheeled 102 Gas-Machine, Anesthesia 107

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

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