SUPERA S-45-030-120-P6Recalls & reported problems
Abbott Vascular Inc. · Supera Peripheral Stent System 4.5 mm x 30 mm x 120 cm 6 F · Class 3 · Implant
All models of SUPERA (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08975370026412), received between Sep 23, 2016 and Sep 23, 2016 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Claudication1
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2016, 5 SUPERA STENTS WERE IMPLANTED IN THE PROXIMAL POPLITEAL TO THE SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT REPORTED ISSUE. THE PATIENT WAS PROVIDED ASPIRIN AND PLAVIX. ON (B)(6) 2016, THE PATIENT PRESENTED TO THE HOSPITAL. THE SAME LEG CONTAINING THE IMPLANTED SUPERA STENTS WAS COLD AND PAINFUL. PER ANGIOGRAM, A BLOOD CLOT WAS NOTED IN ALL 5 STENTS, A TOTAL OCCLUSION. THE PATIENT WAS HOSPITALIZED AND BALLOON ANGIOPLASTY WAS PERFORMED USING A DRUG ELUTING BALLOON. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS PROVIDED OVERNIGHT. THE EVENT RESOLVED WITHOUT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Claudication; Thrombosis
MAUDE report 5975419 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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