SUPERA S-65-150-120-P6 (UDI 08975370026399)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08975370026399), received between Dec 12, 2016 and Aug 6, 2018 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2018Positioning Failure; Mechanical Jam; Activation Failure; Positioning Failure; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-TORTUOUS, CONCENTRIC, 60% STENOSED LESION IN THE DISTAL FEMORAL ARTERY. A CONTRA-LATERAL PUNCTURE WAS MADE AND A 6FR INTRODUCER WAS PLACED. THE .018 INCH GUIDE WIRE WAS ADVANCED CROSSING THE LESION IN PLACE OF POPLITEAL. AN ARMADA 18 BALLOON WAS ADVANCED TO PERFORM PRE-DILATATION OF THE LESION. THE LENGTH AND DIAMETER OF THE STENT WAS EVALUATED. A SUPERA 6.5 X 150 MM STENT WAS CHOSEN. IT WAS PURGED AND THE DEVICE WAS ADVANCED TO THE SEGMENT TO BE TREATED. THE LATCH WAS REMOVED FROM THE SYSTEM TO INITIATE THE RELEASE, THERE WAS A RESISTANCE IN THE THUMBSLIDE AND BY MEANS OF FLUOROSCOPY THE STENT DRIVER SHOWS THAT IT ADVANCES AS THE THUMBSLIDE IS MOVED BUT IT DID NOT INITIATE THE STENT RELEASE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE STENT IMPLANT WAS RETURNED PARTIALLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7754759 ↗
• InjuryMar 7, 2018Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERIPHERAL PROCEDURE TO TREAT A TARGET LESION IN THE MODERATELY CALCIFIED AND TORTUOUS ILIAC ARTERY. DURING DEPLOYMENT, THE SUPERA STENT DEPLOYED IN THE SHEATH AND PINNED THE NOSECONE. THE STENT DELIVERY SYSTEM WAS PULLED AND THE NOSECONE SEPARATED. THE STENT WAS FULLY DEPLOY AT THE TARGET LESION WITHOUT FURTHER DIFFICULTY. A SNARE WAS ADVANCED TO CAPTURE THE SEPARATED NOSECONE; HOWEVER, THE NOSECONE COULD NOT BE PULLED INTO THE SHEATH. AN UNSPECIFIED COVERED STENT WAS DEPLOYED TO CRUSH THE NOSECONE TO THE VESSEL WALL, PROXIMAL TO THE DEPLOYED SUPERA STENT AND IN THE LESION THAT WAS PLANNED TO BE STENTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7322462 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A STENTING PROCEDURE, WITH IMPLANTATION OF A 6.5 X 150 MM SUPERA STENT IN THE POPLITEAL ARTERY. ON (B)(6) 2018, THE PATIENT PRESENTED WITH THROMBUS AND RESTENOSIS IN THE IMPLANTED SUPERA STENT. THROMBECTOMY, ANGIOPLASTY AND IMPLANTATION OF AN ADDITIONAL STENT WERE PERFORMED. THE PATIENT REMAINED IN STABLE CONDITION POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis; Thrombosis

  MAUDE report 7267755 ↗
• MalfunctionJan 19, 2018Positioning Failure; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE 6.5 X 150 MM SUPERA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS DEPLOYED; HOWEVER, AFTER DEPLOYMENT, THE STENT WOULD NOT COME OFF THE DELIVERY SYSTEM AND ELONGATED. THE SDS WAS PUSHED AND PULLED, LOCKED AND UNLOCKED, THE HANDLE WAS TWISTED AND THE THUMBSLIDE WAS MOVED FORWARD AND BACK, BUT THE STENT DID NOT RELEASE FROM THE SDS. THE STENT WAS PULLED OUT AND A NEW SUPERA SDS WAS USED TO 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 Consequences Or Impact To Patient

  MAUDE report 7207885 ↗
• MalfunctionAug 2, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE NON-TORTUOUS 6.7MM-DIAMETER DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, AND PRE-DILATATION WITH A 7.0X150 ARMADA BALLOON (INFLATED TO 4 TO 6 ATMOSPHERES FOR 3 MINUTES), A 6.5X150 6F 120CM SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM (SESS) WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WAS ADVANCED WITHOUT DIFFICULTY TO THE LESION. THE THUMBSLIDE WAS PUSHED WITHOUT DIFFICULTY AND ALL OF THE STENT APPEARED TO HAVE COMPLETELY DEPLOYED UNDER FLUOROSCOPY. THE THUMBSLIDE WAS THEN RETRACTED AND THE SYSTEM LOCK AND DEPLOYMENT LOCK WERE IN THE LOCKED POSITION PER THE IFU. HOWEVER, WHEN ATTEMPTING TO RETRACT THE DELIVERY SYSTEM, RESISTANCE WAS FELT AND IT WAS DISCOVERED THAT A PROXIMAL STENT STRUT WAS CAUGHT ON A DELIVERY SYSTEM RATCHET. FORCE WAS NOT APPLIED. IN AN ATTEMPT TO FREE THE DELIVERY SYSTEM FROM THE STENT, THE PHYSICIAN TWISTED/ROTATED THE SUPERA DELIVERY SYSTEM IN PLACE, POPPING THE RATCHET OFF OF THE STENT STRUT, FREEING THE STENT FROM THE RATCHET. THE SUPERA DELIVERY SYSTEM WAS THEN ABLE TO BE WITHDRAWN WITHOUT FURTHER DIFFICULTY AND THERE WAS NO ELONGATION OR ANY OTHER DAMAG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762094 ↗
• MalfunctionJun 29, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-SUPERFICIAL FEMORAL ARTERY THAT WAS HEAVILY CALCIFIED. NEAR THE END OF DEPLOYMENT OF THE SUPERA PERIPHERAL STENT 6.5 X 150 6F 120 CM, THE RATCHET MECHANISM WOULD NOT RELEASE THE STENT OUT FROM THE SHEATH. THE PHYSICIAN MOVED THE THUMBSLIDE BACK AND FORTH AND LOCKED AND UNLOCKED THE SYSTEM AND THE STENT FINALLY DEPLOYED. THE THUMBSLIDE WAS FULLY RETRACTED TO THE START POSITION AND BOTH THE SYSTEM AND DEPLOYMENT LEVERS LOCKED PRIOR TO REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) HOWEVER WHEN THE SDS WAS BEING RETRACTED, THE NOSE CONE SEPARATED. FORTUNATELY, THE SEPARATED NOSE CONE STUCK TO THE WIRE AND WAS ABLE TO BE PULLED AROUND SHEATH. THE PHYSICIAN THEN USED A HEMOSTAT TO PULL IT OUT OF THE SHEATH. NO ADVERSE PATIENT EFFECT OR DELAY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6679262 ↗
• MalfunctionJun 16, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHILE WIPING DOWN THE DEVICE, THE TIP DETACHED WITHOUT REPORTED RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT USED. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6646766 ↗
• InjuryJun 14, 2017Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR TIBIAL ARTERY INTERVENTION, THE 3.0 X 200 MM ARMADA 14 DILATATION CATHETER BALLOON WAS ADVANCED TO THE TARGET SITE AND INFLATED. THE BALLOON WAS DEFLATED; HOWEVER, DURING REMOVAL, WHEN PULLING THE DEVICE OUT OF THE 6FRENCH SHEATH, IT SEPARATED AND THE SEPARATED SECTION FLOWED TO THE COMMON FEMORAL ARTERY. A SNARE DEVICE WAS ABLE TO RETRIEVE THE SEPARATED SEGMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6640609 ↗
• InjuryApr 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A 6.5X150X120CM 6F SUPERA PERIPHERAL STENT WAS SUCCESSFULLY DEPLOYED IN A 90MM-LONG LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2017, THE PATIENT PRESENTED WITH CLAUDICATION AND AN ANGIOGRAM REVEALED IN-STENT RESTENOSIS (ISR) OF THE SUPERA STENT. THE ISR AND CLAUDICATION WERE SUCCESSFULLY RESOLVED VIA ATHERECTOMY AND ANGIOPLASTY WITH AN UNSPECIFIED 7.0X150MM BALLOON. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Claudication; Stenosis

  MAUDE report 6476011 ↗
• MalfunctionFeb 24, 2017Device Expiration Issue; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2017, THE SUPERA STENT WAS SUCCESSFULLY IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER IMPLANTATION, IT WAS NOTED THAT THE DEVICE WAS EXPIRED. THERE WAS NO DEVICE PERFORMANCE ISSUE AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6358760 ↗
• InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) BEFORE THE PROCEDURE. THE SFA WAS PREPARED WITH ATHERECTOMY AND A 6.0X100 BALLOON DILATATION CATHETER. THE 5.5 X 150 SUPERA STENT WAS IMPLANTED IN THE SFA. IVUS CONFIRMED GOOD BLOOD FLOW IN THE STENT AS WELL AS GOOD FLOW PROXIMAL AND DISTAL TO THE STENT. WHILE THE PATIENT WAS IN THE RECOVERY AREA, THE PATIENT WAS NOTED TO HAVE ASYMPTOMATIC DIMINISHED PULSE VOLUME RECORDING (PVR). ULTRASOUND FOUND THE STENT HAD OCCLUDED. NO ADDITIONAL MEDICATION AND NO ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE PATIENT WILL BE RE-ASSESSED FOR TREATMENT AT A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 6167663 ↗
• InjuryDec 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) BEFORE THE PROCEDURE. THE SFA WAS PREPARED WITH ATHERECTOMY AND A 6.0X100 BALLOON DILATATION CATHETER. TWO SUPERA STENTS, SIZES 6.5X150 AND 6.0X150 WERE IMPLANTED IN THE SFA. IVUS CONFIRMED GOOD BLOOD FLOW IN THE STENT AS WELL AS GOOD FLOW PROXIMAL AND DISTAL TO THE STENT. 90 MINUTES AFTER THE STENT PROCEDURE, THE PATIENT WAS NOTED TO HAVE ASYMPTOMATIC DIMINISHED PULSE VOLUME RECORDING (PVR). ULTRASOUND FOUND BOTH STENTS HAD OCCLUDED. NO ADDITIONAL MEDICATION AND NO ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE PATIENT WILL BE RE-ASSESSED FOR TREATMENT AT A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Occlusion

  MAUDE report 6167646 ↗