2026 data FDA MAUDE openFDA

Stent, Renal

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 Stent, Renal LIGHT-BOOK · MAUDE

#690 of 1000 · 857 reports · 2002–2026

  • BOOK 857 reports
  • RANK #690 of 1000
  • DEATH 32 death-typed
  • INJ 453 injury-typed
  • MALF 367 malfunction
  • SPAN 2002–2026
  • PEAK 2018: 123
  • PHOTO Accessories, Catheter

Nearest event-volume peer: Accessories, Catheter (2 report gap)

Stent, Renal sits #690 of 1000 among tracked device types with 857 MAUDE reports spanning 2002–2026. 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 3.7% corpus 1.5% · above corpus mean (+2.2 pp)
  • INJ 52.9% corpus 30.4% · above corpus mean (+22.4 pp)
  • MALF 42.8% corpus 64.5% · below corpus mean (-21.7 pp)

Lead product-problem code Device Dislodged or Dislocated is 23% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 36% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Stent, Renal in the event-volume neighbourhood

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

reports

What this shows Stent, Renal carries 857 MAUDE reports, ranked #690 of 1000.

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

Event Types

Injury 453 (52.9%)
Malfunction 367 (42.8%)
Death 32 (3.7%)
3 (0.4%)
Other 2 (0.2%)

Patient Outcomes

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

362 (39.1%)
Required Intervention 362 (39.1%)
Other 57 (6.2%)
R 42 (4.5%)
Hospitalization 35 (3.8%)
Death 33 (3.6%)
H 11 (1.2%)
S 7 (0.8%)
O 6 (0.6%)
Life Threatening 4 (0.4%)
L 3 (0.3%)
Disability 3 (0.3%)

Top Product Problems

Device Dislodged or Dislocated 181
Adverse Event Without Identified Device or Use Problem 84
Difficult to Remove 82
Failure to Advance 74
Difficult to Advance 48
Material Deformation 43
Improper or Incorrect Procedure or Method 42
Off-Label Use 31
Activation Failure 27
Leak/Splash 27
Material Rupture 24
Break 19
Material Separation 17
Premature Separation 16
Migration or Expulsion of Device 14
Migration 13
Inflation Problem 10
Unintended System Motion 10
Malposition of Device 9
Positioning Failure 8

Yearly Trend

02
2002: 1
03
2003: 7
04
2004: 13
05
2005: 18
06
2006: 11
07
2007: 8
08
2008: 10
09
2009: 11
10
2010: 4
11
2011: 21
12
2012: 38
13
2013: 45
14
2014: 28
15
2015: 70
16
2016: 34
17
2017: 61
18
2018: 123
19
2019: 62
20
2020: 55
21
2021: 47
22
2022: 39
23
2023: 47
24
2024: 53
25
2025: 42
26
2026: 9

Related Entities for Stent, Renal

Event Locations

414 (48.3%)
I 400 (46.7%)
HOSPITAL 34 (4.0%)
NO INFORMATION 6 (0.7%)
UNKNOWN 2 (0.2%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare AV-TEMECULA-CT vs ABBOTT VASCULAR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stent, Renal, 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 (857 here).

Similar death-typed counts

Nearest other device types by death-typed report count (32 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stent, Renal 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, Renal; 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.