Supera™ S-75-060-120-P6Recalls & reported problems
Abbott Vascular Inc. · Supera™ Peripheral Stent System 7.5 mm x 60 mm x 120 cm 6 F · Class 3 · Implant
All models of SUPERA (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648294488), received between Nov 13, 2024 and Feb 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Difficult or Delayed Positioning1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2025Difficult or Delayed Positioning; Stretched; Difficult or Delayed Positioning; Stretched
IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LEFT COMMON FEMORAL ARTERY WITH DISSECTION FROM A PREVIOUS PROCEDURE. A 7.5X60MM SUPERA SELF-EXPANDING STENT WAS NOTED TO BE DIFFICULT TO VISUALIZE DURING DEPLOYMENT RESULTING IN SEVERE ELONGATION OF THE STENT EXTENDING INTO THE ILIAC ARTERY. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. NO FURTHER TREATMENT WAS PROVIDED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376147 ↗MalfunctionNov 13, 2024Activation Failure; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION, NO TORTUOSITY AND 95% STENOSIS. THE VESSEL DIAMETER IS 7.5 MM CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS) AND THE VESSEL WAS PREPARED WITH A 7 MM BALLOON AT 12 ATMOSPHERES FOR 30 SECONDS. THE 7.5X60 MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION VIA A CONTRALATERAL APPROACH AND DEPLOYMENT WAS STARTED. THE DEVICE RELEASED ABOUT 2 CM OF THE STENT BUT WOULD NOT DEPLOY ANY MORE. SLIGHT TORQUE WAS APPLIED TO THE SHAFT AND AN ATTEMPT WAS MADE TO SLIDE THE THUMBSLIDE BUT THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED WITH THE STENT WITHOUT ISSUE AND A NEW SUPERA SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20676074 ↗
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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