TIGRIS Vascular Stent PHA070802ARecalls & reported problems
W. L. Gore & Associates, Inc. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132636372), received between Dec 27, 2018 and Dec 27, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2018Mechanical Problem; Mechanical Problem
THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR TREATMENT OF A STENOSIS IN THE POPLITEAL ARTERY. A GORE® TIGRIS® VASCULAR STENT WAS ADVANCED THROUGH A 6FR CORDIS SHEATH OVER A .014 SPIDER GUIDEWIRE. THE PHYSICIAN REPORTED THERE WAS TREMENDOUS RESISTANCE AS THE TIGRIS STENT WAS ADVANCED THROUGH THE SHEATH. THE TIGRIS STENT WAS ABLE TO REACH THE INTENDED TREATMENT SITE AND DEPLOYMENT WAS INITIATED. ABOUT THREE-FOURTH OF THE STENT EXPANDED WHEN DEPLOYMENT WHEEL COULD NO LONGER BE ROTATED. MOST OF THE STENT WAS PULLED BACK INTO THE 6FR CORDIS SHEATH AND REMOVED IN TANDEM. WIRE ACCESS WAS MAINTAINED, WHICH ALLOWED FOR EVERFLEX STENTS TO BE DEPLOYED. AS REPORTED, PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8201753 ↗
Other Stent, Superficial Femoral Artery devices
- EverFlex™ EVD35-06-150-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 death110 reports
- SUPERA S-60-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY108 reports
- SUPERA S-55-150-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY88 reports
- LifeStent® Solo Vascular Stent EX062003CLBard Peripheral Vascular, Inc. · STENT, SUPERFICIAL FEMORAL ARTERY80 reports
- BioMimics 3D Vascular Stent System 144700-12Veryan Medical Limited · Stent, Superficial Femoral Artery74 reports
- SUPERA S-50-120-120-P6Abbott Vascular Inc. · STENT, SUPERFICIAL FEMORAL ARTERY55 reports
- EverFlex™ EVD35-07-060-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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