Supera™ S-75-100-120-P6Recalls & reported problems
Abbott Vascular Inc. · Supera™ Peripheral Stent System 7.5 mm x 100 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648294501), received between Jun 8, 2023 and Jun 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 16, 2026.
Most reported problems
Device problems
- Difficult or Delayed Activation1
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2023Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking; Stretched; Difficult or Delayed Activation; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERIOR FEMORAL ARTERY (SFA) WITH MILD TORTUOSITY, MILD CALCIFICATION AND 80% STENOSIS. A 6 FR 6MM SHEATH WAS USED IN A 7.5 MM VESSEL AND A NON-ABBOTT BALLOON WAS USED TO PRE-DILATE THE LESION. THE 7.5X100MM SUPERA SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, THE THUMBSLIDE WAS BEING MOVED BACK AND FORTH AND THE STENT STOPPED DEPLOYING; THEREFORE, THE STENT WAS REPOSITIONED BY ROTATING AND SHAKING THE HANDLE AND PULLING THE DEPLOYMENT SHAFT STRAIGHT UNTIL RESISTANCE WAS MET. THE STENT THEN ENGAGED AND THE STENT WAS ULTIMATELY DEPLOYED, BUT A PORTION OF THE STENT REMAINED IN THE TARGET LESION, AND A PORTION REMAINED IN HEALTHY TISSUE AND WAS NOTED ELONGATED. THERE WAS NO OTHER DEVICE USED TO TREAT THE LESION. THERE WERE 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 17089327 ↗
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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