SUPERA S-45-060-120-P6 (UDI 08717648225949)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648225949), received between Aug 29, 2019 and May 22, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Premature Activation; Difficult to Remove; Material Separation; Difficult to Advance; Material Deformation; Premature Activation; Difficult to Remove; Material Separation; Difficult to Advance; Material Deformation

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE TIP WAS SEPARATED AND NOT RETURNED. FOLLOW UP FOUND THAT THE ACCOUNT WAS AWARE OF THE SEPARATION, AS IT OCCURRED DURING REMOVAL OF THE SUPERA STENT DELIVERY SYSTEM WHEN THE NOSE CONE CAUGHT ON THE SHEATH. THE SEPARATED TIP WAS REMOVED WHEN BOTH DEVICES WERE REMOVED TOGETHER. THE SEPARATED TIP WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374792 ↗
• InjuryDec 27, 2023Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT (MW5148102) RECEIVED STATING: ABBOTT SUPERA STENT DELIVERY DEVICE WAS INSERTED OVER THE WIRE AND WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED. CARDIOLOGIST NOTICED A PIECE OF THE DELIVERY SYSTEM MISSING AND THE STENT WAS OFF THE DELIVERY DEVICE. THE MISSING PIECE WAS SNARED AND RETRIEVED. ADDITIONAL INFORMATION RECEIVED FROM THE SITE: THE VESSEL TREATED WAS THE DISTAL LEFT POPLITEAL ARTERY THAT IS SEVERELY DISEASED AT 90-95%. THERE WAS RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. NOTHING REMAINS IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18401390 ↗
• InjuryFeb 10, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL AND DISTAL FEMORAL ARTERY (SFA) VIA A DIRECT STICK TO THE POPLITEAL THROUGH A BYPASS GRAFT. THE VESSEL DIAMETER WAS 4-4.5MM, AND THE ATHERECTOMY WAS NOT USED. DURING PREPARATION OF A 4.5X40MM SUPERA SELF EXPANDING STENT (SSES) THE NOSECONE APPEARANCE DID NOT LIKE HOW IT LOOKED THEREFORE WAS NOT USED IN THE PATIENT. ANOTHER 4.5X60MM SUPERA SSES WAS PREPARED, AND THE VESSEL WAS PREPARED WITH A BALLOON DILATATION. THE STENT WAS DEPLOYED; AND DURING REMOVAL UNDER FLUOROSCOPY, THE RED LEVERS WERE NOT LOCKED BEFORE THE CATHETER WAS BEING PULLED OUT, THE NOSECONE GOT STUCK ON THE STENT STRUT AND THEN DETACHED. THE NOSECONE WAS UNABLE TO BE REMOVED FROM THE LOCATION. THE DELIVERY SYSTEM WAS REMOVED UNDER FLUOROSCOPY. THE NOSECONE REMAINS IN THE PERONEAL ARTERY; HOWEVER, THE ARTERY WAS CONFIRMED TO BE PATENT. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS OF THE 4.5X40 SUPERA SESS IDENTIFIED A SEPARATED TIP WHICH WAS NOT RETURNED. THE ACCOUNT STATED IT WAS LIKELY DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16354389 ↗
• MalfunctionApr 5, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A 4.5X60MM SUPERA SELF-EXPANDING STENT SYSTEM (SESS), THE DEVICE WAS BEING FLUSHED WHEN THE TIP BECAME SEPARATED. THE SESS WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 5X80MM ABSOLUTE PRO SELF-EXPANDING STENT SYSTEM (SESS) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018110 ↗
• MalfunctionJul 22, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT BEFORE THAT DURING PREPARATION, THE SHEATH PORT CRACKED WHEN DOING THE INITIAL FLUSH. SUBSEQUENTLY, WHEN THE DEVICE WAS BEING FLUSHED, CONTRAST WOULD SPRAY OUT OF THE SIDE WALL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SUPERA WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 12211181 ↗
• MalfunctionAug 29, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 4.5 X 60 MM SUPERA PERIPHERAL STENT SYSTEM WAS USED WITHOUT ANY ISSUES. HOWEVER, IT WAS NOTED AFTER IMPLANTATION THAT THE DEVICE HAD EXPIRED ON 06/30/ 2019. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945245 ↗