2026 data FDA MAUDE openFDA FDA Class II

Pancreatic Stent, Covered, Metallic, Removable

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 §876.5015 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Pancreatic Stent LIGHT-BOOK · MAUDE

#485 of 1000 · 2,138 reports · 2014–2026

  • BOOK 2,138 reports
  • RANK #485 of 1000
  • DEATH 65 death-typed
  • INJ 1,132 injury-typed
  • MALF 939 malfunction
  • SPAN 2014–2026
  • PEAK 2024: 416
  • PHOTO Cutaneous Tissue Adhe…

Nearest event-volume peer: Cutaneous Tissue Adhesive With Mesh (1 report gap)

Pancreatic Stent, Covered, Metallic, Removable sits #485 of 1000 among tracked device types with 2,138 MAUDE reports spanning 2014–2026. 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 →

Injury-coded reports run above the device-type norm

Pancreatic Stent carries 52.9% INJURY-coded reports, 22.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.5 pp)
  • INJ 52.9% corpus 30.3% · above corpus mean (+22.7 pp)
  • MALF 43.9% corpus 64.8% · below corpus mean (-20.9 pp)

Lead product-problem code Use of Device Problem is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 88% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .

Pancreatic Stent in the event-volume neighbourhood

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

reports

What this shows Pancreatic Stent, Covered, Metallic, Removable carries 2,138 MAUDE reports, ranked #485 of 1000.

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

Event Types

Injury 1,132 (52.9%)
Malfunction 939 (43.9%)
Death 65 (3.0%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 1,026 (45.2%)
932 (41.1%)
R 83 (3.7%)
Hospitalization 79 (3.5%)
Death 51 (2.2%)
H 47 (2.1%)
Other 24 (1.1%)
O 13 (0.6%)
D 11 (0.5%)
Life Threatening 3 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Use of Device Problem 562
Positioning Problem 460
Adverse Event Without Identified Device or Use Problem 423
Activation, Positioning or Separation Problem 356
Positioning Failure 346
Activation Failure 316
Migration 144
Premature Activation 140
Break 131
Detachment of Device or Device Component 97
Difficult to Remove 97
Entrapment of Device 90
Difficult or Delayed Positioning 84
Electrical /Electronic Property Problem 76
Device Stenosis 54
Material Integrity Problem 53
Difficult to Advance 51
Material Deformation 43
Migration or Expulsion of Device 41
Appropriate Device Problem Term/Code Not Available 32

Yearly Trend

14
2014: 3
15
2015: 17
16
2016: 101
17
2017: 95
18
2018: 90
19
2019: 136
20
2020: 144
21
2021: 162
22
2022: 208
23
2023: 260
24
2024: 416
25
2025: 301
26
2026: 205

Reports in 2025 (301) held close to the prior two-year average of 338.

Related Entities for Pancreatic Stent, Covered, Metallic, Removable

Event Locations

1,425 (66.7%)
I 690 (32.3%)
HOSPITAL 14 (0.7%)
NO INFORMATION 6 (0.3%)
OTHER 3 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pancreatic Stent: 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 (2,138 here).

Similar death-typed counts

Nearest other device types by death-typed report count (65 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pancreatic Stent 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 Pancreatic Stent; 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.