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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Stent, Renal LIGHT-BOOK · MAUDE

#702 of 1000 · 874 reports · 2002–2026

  • BOOK 874 reports
  • RANK #702 of 1000
  • DEATH 32 death-typed
  • INJ 460 injury-typed
  • MALF 377 malfunction
  • SPAN 2002–2026
  • PEAK 2018: 123
  • PHOTO Susceptibility Test P…

Nearest event-volume peer: Susceptibility Test Powders, Antimycobacterial (0 report gap)

Stent, Renal sits #702 of 1000 among tracked device types with 874 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 →

Injury-coded reports run above the device-type norm

Stent, Renal carries 52.6% INJURY-coded reports, 22.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.7% corpus 1.5% · above corpus mean (+2.2 pp)
  • INJ 52.6% corpus 30.3% · above corpus mean (+22.3 pp)
  • MALF 43.1% corpus 64.8% · 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 49% 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 874 MAUDE reports, ranked #702 of 1000.

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

Event Types

Injury 460 (52.6%)
Malfunction 377 (43.1%)
Death 32 (3.7%)
3 (0.3%)
Other 2 (0.2%)

Patient Outcomes

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

372 (39.4%)
Required Intervention 370 (39.2%)
Other 57 (6.0%)
R 42 (4.5%)
Hospitalization 35 (3.7%)
Death 33 (3.5%)
H 11 (1.2%)
S 7 (0.7%)
O 6 (0.6%)
Life Threatening 4 (0.4%)
L 3 (0.3%)
Disability 3 (0.3%)

Top Product Problems

Device Dislodged or Dislocated 255
Difficult to Remove 139
Adverse Event Without Identified Device or Use Problem 126
Failure to Advance 112
Improper or Incorrect Procedure or Method 72
Difficult to Advance 58
Material Deformation 53
Leak/Splash 35
Off-Label Use 32
Material Rupture 31
Migration or Expulsion of Device 28
Activation Failure 27
Difficult To Position 25
Break 24
Detachment Of Device Component 22
Material Separation 22
Inflation Problem 20
Device remains implanted 16
Occlusion Within Device 16
Premature Separation 16

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: 26

Reports in 2025 (42) held close to the prior two-year average of 50.

Related Entities for Stent, Renal

Top Manufacturers

AV-TEMECULA-CT 224
ABBOTT VASCULAR 140
ABBOTT VASCULAR INC. 91
BOSTON SCIENTIFIC CORPORATION 89
ATRIUM MEDICAL CORPORATION 56
COOK INC 19

Event Locations

431 (49.3%)
I 400 (45.8%)
HOSPITAL 34 (3.9%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stent, Renal: 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 (874 here).

Susceptibility Test Powders 874 Condylar Plate Fixation Implant 876 Graft 878 Culture Media 879

Similar death-typed counts

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

Cleanser, Denture, Over The Counter 32 Dorsal Root Ganglion Stimulator For Pain Re… 32 Bed, Air Fluidized 33 Catheter, Umbilical Artery 33

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

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.