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2026 data FDA MAUDE openFDA FDA Class III

Shunt, Portosystemic, Endoprosthesis

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

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FDA MAUDE casebook

openFDA event book Shunt, Portosystemic, Endoprosthesis LIGHT-BOOK · MAUDE

#932 of 1000 · 444 reports · 1993–2026

  • BOOK 444 reports
  • RANK #932 of 1000
  • DEATH 25 death-typed
  • INJ 260 injury-typed
  • MALF 146 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 40
  • PHOTO Shockwave Intravascul…

Nearest event-volume peer: Shockwave Intravascular Lithotripsy System (1 report gap)

Shunt, Portosystemic, Endoprosthesis sits #932 of 1000 among tracked device types with 444 MAUDE reports spanning 1993–2026. 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

Shunt, Portosystemic, Endoprosthesis carries 32.9% MALFUNCTION-coded reports, 31.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 58.6% corpus 30.3% · above corpus mean (+28.3 pp)
  • MALF 32.9% corpus 64.8% · below corpus mean (-31.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 16% of coded problems · Lead manufacturer W. L. GORE & ASSOCIATES, INC. accounts for 49% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .

Shunt, Portosystemic, Endoprosthesis in the event-volume neighbourhood

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

reports

What this shows Shunt, Portosystemic, Endoprosthesis carries 444 MAUDE reports, ranked #932 of 1000.

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

Event Types

Injury 260 (58.6%)
Malfunction 146 (32.9%)
Death 25 (5.6%)
Other 10 (2.3%)
3 (0.7%)

Patient Outcomes

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

Required Intervention 165 (30.8%)
124 (23.1%)
Other 67 (12.5%)
R 62 (11.6%)
Hospitalization 57 (10.6%)
Death 27 (5.0%)
H 15 (2.8%)
O 10 (1.9%)
Life Threatening 5 (0.9%)
L 2 (0.4%)
S 2 (0.4%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 70
Device remains implanted 34
Dislodged 30
Activation Failure 28
Balloon rupture 25
Balloon burst 24
Insufficient Device Problem Information 22
Replace 22
Break 20
Positioning Failure 19
Difficult or Delayed Positioning 18
Explanted 15
Obstruction of Flow 15
Difficult to Remove 14
Migration or Expulsion of Device 14
Occlusion Within Device 14
Complete Blockage 13
Fracture 13
Patient-Device Incompatibility 12
Device Stenosis 10

Yearly Trend

93
1993: 1
94
1994: 1
96
1996: 8
97
1997: 27
98
1998: 36
99
1999: 20
00
2000: 7
02
2002: 1
03
2003: 5
04
2004: 13
05
2005: 37
06
2006: 15
07
2007: 1
08
2008: 4
09
2009: 6
10
2010: 8
11
2011: 7
12
2012: 9
13
2013: 11
14
2014: 8
15
2015: 6
16
2016: 8
17
2017: 13
18
2018: 20
19
2019: 29
20
2020: 14
21
2021: 13
22
2022: 23
23
2023: 22
24
2024: 40
25
2025: 16
26
2026: 15

Reports fell to 16 in 2025, down from an average of 31 in the two years before.

Related Entities for Shunt, Portosystemic, Endoprosthesis

Top Manufacturers

W. L. GORE & ASSOCIATES, INC. 130
W.L. GORE & ASSOCIATES 111
BOSTON SCIENTIFIC 17
BOSTON SCIENTIFIC CORPORATION 7

Event Locations

199 (44.8%)
HOSPITAL 123 (27.7%)
I 99 (22.3%)
UNKNOWN 12 (2.7%)
NOT APPLICABLE 10 (2.3%)
NO INFORMATION 1 (0.2%)

Compare W. L. GORE & ASSOCIATES, INC. vs W.L. GORE & ASSOCIATES →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Shunt, Portosystemic, Endoprosthesis: 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 (444 here).

Shockwave Intravascular Lithotripsy System 445 System, X-Ray, Mammographic 443 Biliary Catheter For Stone Removal That May… 441 Inhibitor, Peridural Fibrosis 440

Similar death-typed counts

Nearest other device types by death-typed report count (25 here), distinct from the volume row.

Aid, Transfer 25 Analyzer, Chemistry, For Clinical Use 25 Hemostatic Metal Clip For The Gi Tract 25 Stopcock, I.V. Set 25

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

Disclaimer: MAUDE figures for Shunt, Portosystemic, Endoprosthesis 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 Shunt, Portosystemic, Endoprosthesis; 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.