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2026 data FDA MAUDE openFDA

Endovascular Suturing System

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 Endovascular Suturing System LIGHT-BOOK · MAUDE

#618 of 1000 · 1,165 reports · 2012–2026

  • BOOK 1,165 reports
  • RANK #618 of 1000
  • DEATH 125 death-typed
  • INJ 616 injury-typed
  • MALF 419 malfunction
  • SPAN 2012–2026
  • PEAK 2018: 215
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Neurovasculature (5 report gap)

Endovascular Suturing System sits #618 of 1000 among tracked device types with 1,165 MAUDE reports spanning 2012–2026. 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 10.7% corpus 1.5% · above corpus mean (+9.2 pp)
  • INJ 52.9% corpus 30.4% · above corpus mean (+22.4 pp)
  • MALF 36.0% corpus 64.5% · below corpus mean (-28.5 pp)

Lead product-problem code Leak/Splash is 34% of coded problems · Lead manufacturer MEDTRONIC IRELAND accounts for 98% of manufacturer-tagged reports · Top event location I is 75% of location-tagged rows .

Endovascular Suturing System in the event-volume neighbourhood

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

reports

What this shows Endovascular Suturing System carries 1,165 MAUDE reports, ranked #618 of 1000.

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

Event Types

Injury 616 (52.9%)
Malfunction 419 (36.0%)
Death 125 (10.7%)
Other 4 (0.3%)
1 (0.1%)

Patient Outcomes

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

Required Intervention 577 (44.7%)
337 (26.1%)
Death 121 (9.4%)
R 105 (8.1%)
Hospitalization 61 (4.7%)
Other 53 (4.1%)
O 15 (1.2%)
Life Threatening 10 (0.8%)
D 4 (0.3%)
L 3 (0.2%)
S 2 (0.2%)
Disability 2 (0.2%)

Top Product Problems

Leak/Splash 424
Adverse Event Without Identified Device or Use Problem 359
Device Dislodged or Dislocated 88
Fracture 72
Break 49
Malposition of Device 45
Activation, Positioning or Separation Problem 35
Device Damaged by Another Device 33
Device Difficult to Setup or Prepare 33
Material Deformation 18
Device Contamination with Chemical or Other Material 14
Difficult to Insert 14
Component Missing 13
Migration or Expulsion of Device 12
Misfire 10
Device Displays Incorrect Message 9
Insufficient Information 8
Device Operates Differently Than Expected 7
Difficult to Remove 7
Detachment of Device or Device Component 5

Yearly Trend

12
2012: 1
13
2013: 5
14
2014: 16
15
2015: 72
16
2016: 166
17
2017: 161
18
2018: 215
19
2019: 141
20
2020: 101
21
2021: 59
22
2022: 52
23
2023: 52
24
2024: 62
25
2025: 56
26
2026: 6

Related Entities for Endovascular Suturing System

Top Manufacturers

MEDTRONIC IRELAND 695
MEDTRONIC CARDIOVASCULAR 8
MEDTRONIC, INC. 4

Event Locations

I 877 (75.3%)
277 (23.8%)
HOSPITAL 6 (0.5%)
NO INFORMATION 5 (0.4%)

Compare MEDTRONIC IRELAND vs MEDTRONIC CARDIOVASCULAR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Endovascular Suturing System, 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 (1,165 here).

Catheter, Percutaneous, Neurovasculature 1,170 Holder, Ureteral Catheter 1,173 Wire, Surgical 1,173 Agent, Tooth Bonding, Resin 1,156

Similar death-typed counts

Nearest other device types by death-typed report count (125 here), distinct from the volume row.

Catheter 125 Catheter, Peripheral, Atherectomy 126 Humidifier, Respiratory Gas, 124 Peripheral Mechanical Thrombectomy With Asp… 126

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

Disclaimer: MAUDE figures for Endovascular Suturing System 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 Endovascular Suturing System; 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.