PlainHospital

W.L. GORE & ASSOCIATES

Manufacturer adverse-event records for W.L. GORE & ASSOCIATES come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1994–2022 · mid-book · elevated Death-code · injury-heavy

Death-code intensity

W.L. GORE & ASSOCIATES carries an elevated Death-code share

Death-coded event_type rows are 858 of 13,722 (6.25% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for W.L. GORE & ASSOCIATES

The standout signal for W.L. GORE & ASSOCIATES is Death-code intensity: 6.25% of 13,722 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for W.L. GORE & ASSOCIATES. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Injury at 11,522 (84.0% of event_type total). Peak single-year volume reaches 2,445 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

13,722
Total Reports
858
Event-type Death
11,522
Injury Reports
20
Device Types

Event Types

Injury 11,522 (84.0%)
Malfunction 1,318 (9.6%)
Death 858 (6.3%)
Other 14 (0.1%)
10 (0.1%)

Patient Outcomes

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

Hospitalization 6,930 (31.1%)
R 6,545 (29.4%)
Required Intervention 2,882 (12.9%)
Other 1,842 (8.3%)
O 1,523 (6.8%)
993 (4.5%)
Death 902 (4.0%)
H 196 (0.9%)
L 156 (0.7%)
S 148 (0.7%)
Life Threatening 91 (0.4%)
Disability 80 (0.4%)
Congenital Anomaly 1 (0.0%)

Devices (20)

Device Reports
System, Endovascular Graft, Aortic Aneurysm Treatment 8,185
Mesh, Surgical, Polymeric 1,443
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter 884
Introducer, Catheter 717
Stent, Superficial Femoral Artery 694
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment 476
Transcatheter Septal Occluder 389
Suture, Nonabsorbable, Synthetic, Polypropylene 195
Stent, Iliac 188
Shunt, Portosystemic, Endoprosthesis 111
Catheter, Percutaneous 72
Mesh, Surgical 70
Stents, Drains And Dilators For The Biliary Ducts 46
Iliac Covered Stent, Arterial 37
Mesh, Surgical, Absorbable, Abdominal Hernia 36
Temporary Carotid Catheter For Embolic Capture 35
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene 34
Dura Substitute 31
Prosthesis, Tracheal, Expandable 25
Laparoscope, General & Plastic Surgery 20

Yearly Trend

94
1994: 1
96
1996: 2
97
1997: 1
98
1998: 2
99
1999: 3
00
2000: 1
01
2001: 1
03
2003: 15
04
2004: 71
05
2005: 63
06
2006: 17
07
2007: 14
08
2008: 287
09
2009: 573
10
2010: 528
11
2011: 653
12
2012: 811
13
2013: 695
14
2014: 947
15
2015: 1,300
16
2016: 1,570
17
2017: 1,301
18
2018: 1,526
19
2019: 2,445
20
2020: 876
21
2021: 8
22
2022: 11

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