Epic™ Vascular H74939200108070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729805090), received between Apr 17, 2019 and Nov 28, 2022 — classified as 1 death, 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionNov 28, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT EXPANSION FAILURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED VEIN IN THE BILIARY SYSTEM. A 10X80X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS DEPLOYED OF ABOUT 95%, IT WAS NOTICED THAT THE RADIAL FORCE DOES NOT SEEM TO BE ENOUGH.; HENCE, POST-DILATATION WAS PERFORMED. EVENTUALLY, THE STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870095 ↗
• MalfunctionNov 28, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT EXPANSION FAILURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED BILIARY. A 10X80X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE RADIAL FORCE DOES NOT SEEM TO BE ENOUGH. EVENTUALLY, THE STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869479 ↗
• MalfunctionNov 21, 2022Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT EXPANSION FAILURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED BILE DUCT. A 10 X 80 X 75 EPIC VASCULAR STENT WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT FAILED TO FULLY EXPAND, IT WAS 95% DEPLOYED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838844 ↗
• InjuryNov 15, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT SHAFT BREAK AND STENT DEPLOYMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY. TWO 10X80X75 EPIC STENTS WERE USED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE ON BOTH DEVICES, THE SHAFT CAME APART FROM THE STENT BEFORE FULLY DEPLOYMENT. ADDITIONAL STENT WAS DEPLOYED TO MAKE SURE ORIGINAL STENTS STAYED DEPLOYED AND FULLY OPENED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814640 ↗
• InjuryNov 15, 2021Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT SHAFT BREAK AND STENT DEPLOYMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY. TWO 10X80X75 EPIC STENTS WERE USED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE ON BOTH DEVICES, THE SHAFT CAME APART FROM THE STENT BEFORE FULLY DEPLOYMENT. ADDITIONAL STENT WAS DEPLOYED TO MAKE SURE ORIGINAL STENTS STAYED DEPLOYED AND FULLY OPENED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814517 ↗
• MalfunctionFeb 3, 2021Difficult or Delayed Positioning; Failure to Advance; Material Deformation; Difficult or Delayed Positioning; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 10X80X75 EPIC STENT SELF EXPANDING WAS ADVANCED; HOWEVER, RESISTANCE WAS FELT AND THE DEVICE FAILED TO CROSS THE LESION. AFTER REMOVAL, IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO DEPLOY AND IT WAS CONFIRMED THAT THE DISTAL TIP OF THE STENT WAS CRUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274551 ↗
• DeathFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION AND BLEEDING OCCURRED, AND THE PATIENT DIED. THE 100% STENOSED, 8MM X 15 CM IN LENGTH TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT ILIAC ARTERY. AN 8X60X75 AND 10X80X75 EPIC VASCULAR STENTS WERE ADVANCED AND IMPLANTED WITHOUT ISSUE. POST DILATATION WAS THEN PERFORMED WITH AN 8.0MMX60MMX135CM STERLING BALLOON CATHETER; HOWEVER, PERFORATION WAS NOTED. THE PHYSICIAN ADMINISTERED PROTAMINE TO THE PATIENT. HEMOSTASIS WAS THEN PERFORMED BY DILATATION FOR 80 MINUTES WITH THE SAME BALLOON CATHETER AND THE DEVICE WAS ABLE TO STOP THE BLEEDING. ON THE FOLLOWING DAY, RE-BLEEDING WAS NOTED, AND 2 NON-BOSTON SCIENTIFIC STENTS WERE PLACED. TWO DAYS POST PROCEDURE, THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 11267486 ↗
• InjuryApr 15, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT PARTIALLY EXPANDED OCCURRED. A 10X80X75MM EPIC VASCULAR STENT WAS INSERTED AND DEPLOYED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE STENT DID NOT FULLY EXPAND AT DISTAL END. THE DEVICE HAS ENDED UP BEING PINCHED ON THE END EVEN AFTER IT WAS BALLOONED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9962512 ↗
• InjuryJan 24, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WERE REMOVAL DIFFICULTIES AND THE PATIENT EXPERIENCE PAIN. THE TARGET LESION WAS LOCATED IN THE BILIARY. A 10X80X75 EPIC VASCULAR STENT WAS ADVANCED AND PLACED FOR TREATMENT. HOWEVER, AFTER POSITIONING THE STENT IN THE LESION, THE ORANGE MARKER OF SHAFT WAS STUCK IN THE CELL OF THE STENT. WHEN TRYING TO MOVE THE SHAFT, THE PATIENT FELT PAIN AND SO IT WAS MOVED FORWARD SLOWLY FROM THE PATIENT'S BODY AND WAS SUCCESSFULLY REMOVED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: Pain

  MAUDE report 9627930 ↗
• MalfunctionNov 26, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT MISSING MARKER BANDS OCCURRED. THE TARGET LESION WAS LOCATED IN THE BILIARY DUCT. A 10X80X75MM EPIC STENT WAS OPENED HOWEVER, PRIOR TO LOADING ON THE WIRE, IT WAS NOTED THAT DISTAL MARKERS WERE MISSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS GOOD.

  Patient problems: No Patient Involvement

  MAUDE report 9376114 ↗
• MalfunctionApr 19, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT STENT WAS NOT VISIBLE UNDER FLUOROSCOPY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUSITY AND MODERATELY CALCIFIED EXTERNAL ILIAC ARTERY (EIA) AND COMMON ILIAC ARTERY (CIA). EPIC STENTS WERE PLACED IN BOTH EIA AND CIA, BUT THE ONE PLACED IN CIA DID NOT APPEAR ON THE CINE CARDIOANGIOGRAPHY. HOWEVER, UPON ANGIOGRAPHY BY THE PHYSICIAN, IT WAS CONFIRMED TO BE DEPLOYED AND HAS BEEN PLACED. THE NON-BSC DIAGNOSTIC DEVICE PLACED IN CIA, IN WHICH EPIC BODY SIDE WAS PLACED IN EIA COULD BE CONFIRMED BY FLUOROSCOPY. THE EPIC IN CIA HAD THIN REAR MARKER, HOWEVER IT WAS ABLE TO BE CONFIRMED, BUT THE MARKER STRUT AT THE TIP ALMOST COULD NOT BE SEEN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531830 ↗
• MalfunctionApr 17, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM BECAME STUCK ON THE GUIDEWIRE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. AFTER ADVANCING THE LESION WITH A 0.035 NON-BSC GUIDEWIRE, A 10X80X75MM EPIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED TO HAVE STUCK MIDWAY, AND THE DEVICE WAS REMOVED TOGETHER WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523604 ↗