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2026 data FDA MAUDE openFDA FDA Class II

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.

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

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FDA MAUDE casebook

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

#598 of 1000 · 1,319 reports · 1997–2026

  • BOOK 1,319 reports
  • RANK #598 of 1000
  • DEATH 105 death-typed
  • INJ 626 injury-typed
  • MALF 586 malfunction
  • SPAN 1997–2026
  • PEAK 2009: 152
  • PHOTO Peripheral Mechanical…

Nearest event-volume peer: Peripheral Mechanical Thrombectomy With Aspiration (1 report gap)

Stent, Colonic, Metallic, Expandable sits #598 of 1000 among tracked device types with 1,319 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 →

Malfunction reports sit below the device-type norm

Stent, Colonic, Metallic, Expandable carries 44.4% MALFUNCTION-coded reports, 20.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 8.0% corpus 1.5% · above corpus mean (+6.5 pp)
  • INJ 47.5% corpus 30.3% · above corpus mean (+17.2 pp)
  • MALF 44.4% corpus 64.8% · below corpus mean (-20.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 13% 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 1,319 MAUDE reports, ranked #598 of 1000.

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

Event Types

Injury 626 (47.5%)
Malfunction 586 (44.4%)
Death 105 (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.

580 (41.0%)
Required Intervention 394 (27.8%)
Other 160 (11.3%)
Death 101 (7.1%)
Hospitalization 80 (5.6%)
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 171
Activation, Positioning or Separation Problem 157
Positioning Problem 108
Break 105
Activation Failure 81
Positioning Failure 79
Migration or Expulsion of Device 76
Other (for use when an appropriate device code cannot be identified) 69
Premature Activation 67
Material Deformation 59
Difficult to Remove 58
Unknown (for use when the device problem is not known) 58
Occlusion Within Device 53
Delamination 43
Difficult or Delayed Positioning 35
Insufficient Device Problem Information 35
Appropriate Device Problem Term/Code Not Available 33
Device remains implanted 27
Migration 27
Material Perforation 26

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: 21

Reports fell to 29 in 2025, down from an average of 54 in the two years before.

Related Entities for Stent, Colonic, Metallic, Expandable

Top Manufacturers

BOSTON SCIENTIFIC - GALWAY 474
BOSTON SCIENTIFIC CORPORATION 264
COOK IRELAND LTD 155
BOSTON SCIENTIFIC 88
BOSTON SCIENTIFIC CORP 13

Event Locations

933 (70.7%)
I 206 (15.6%)
HOSPITAL 174 (13.2%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Colonic, Metallic, Expandable: 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 (1,319 here).

Peripheral Mechanical Thrombectomy With Asp… 1,318 Pump, Air, Non-Manual, For Endoscope 1,316 Disinfector, Medical Devices 1,315 Agent, Occluding, Vascular, Permanent 1,325

Similar death-typed counts

Nearest other device types by death-typed report count (105 here), distinct from the volume row.

Interventional Fluoroscopic X-Ray System 105 Catheter, Septostomy 104 Neurological Stereotaxic Instrument 104 Separator 106

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.