SUPERA S-65-080-120-P6 (UDI 08975370026368)Recalls & reported problems
Abbott Vascular Inc. · Supera Peripheral Stent System 6.5 mm x 80 mm x 120 cm 6 F · Class 3 · Implant
Data updated Oct 13, 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 08975370026368), received between Sep 13, 2016 and Nov 15, 2022 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Activation Failure1
- Device Expiration Issue1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2022Difficult to Remove; Mechanical Jam; Activation Failure; Difficult to Remove; Mechanical Jam; Activation Failure
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 6.5X80MM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION. UPON DEPLOYMENT, THE THUMBSLIDE STOPPED AND IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS CAUGHT ON THE STENT. THE STENT WAS ONLY PARTIALLY DEPLOYED. IT WAS DECIDED TO REMOVE THE DEVICE INCLUDING THE STENT. RESISTANCE WAS NOTED SO THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE SHEATH. IT IS UNKNOWN IF THE STENT WAS REMOVED OR REMAINS IN THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DRUG COATED BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802055 ↗MalfunctionSep 13, 2016Device Expiration Issue; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT A SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL BYPASS GRAFT WITHOUT ISSUE. AFTER IMPLANTATION, IT WAS NOTED THAT THE STENT HAD EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5948121 ↗
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™ EVD35-07-120-120Covidien LP · STENT, SUPERFICIAL FEMORAL ARTERY1 recall5 reports
- EverFlex™ EVD35-07-060-120Covidien 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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