Epic™ Vascular H74939200088020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729805724), received between Apr 26, 2017 and Jun 27, 2024 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. AN 8X80X120 EPIC VASCULAR SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT. DURING UNPACKING, IT WAS NOTED THAT THE STENT HAS SIGNIFICANT CREASES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629491 ↗
• MalfunctionAug 8, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 8 X 80 X 120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, AFTER UNPACKING, IT WAS NOTICED THAT THERE WAS A SPACE AT THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482572 ↗
• MalfunctionJun 1, 2023Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT TRACKING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FEMORAL ARTERY. AFTER A 6F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS PLACED AND A 0.035 AMPLATZ GUIDEWIRE WAS CROSSED THE LESION, AN 8X80X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE TIP OF THE STENT COULD NOT CROSS ABOUT 9CM INTO THE END OF THE GUIDEWIRE. THE PROBLEM STILL OCCURRED EVEN AFTER THE PHYSICIAN REPLACED THE GUIDEWIRE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT PARTIAL DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039101 ↗
• MalfunctionOct 31, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE PATIENT PRESENTED WITH THORACIC AORTIC ANEURYSM AND UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TVAR). A 8X80X120 EPIC VASCULAR STENT WAS ADVANCED OVER A 0.014 INCH GUIDEWIRE. HOWEVER, DURING DEPLOYMENT, ONLY A PART OF THE STENT WAS DEPLOYED DESPITE MULTIPLE ATTEMPTS. THE STENT WAS REMOVED WITH THE DELIVERY SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703843 ↗
• MalfunctionApr 5, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY. FOLLOWING PRE-DILATATION, A 8X80X120 EPIC VASCULAR STENT WAS ADVANCED OVER A NON-BSC GUIDEWIRE. HOWEVER, UPON REMOVAL, THE STENT DELIVERY SYSTEM WAS STUCK ON THE GUIDEWIRE AND COULD NOT BE PULLED OUT SO THE DELIVERY SYSTEM WAS REMOVED TOGETHER WITH THE GUIDEWIRE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616311 ↗
• InjuryNov 5, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING DIFFICULTY WAS ENCOUNTERED. AN 8X80X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT OF THE STENT, THE STENT JUMP SIGNIFICANTLY AND MISSED THE MARK WHERE IT WAS SUPPOSEDLY BE PLACED. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT COMMON ILIAC ARTERY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9280658 ↗
• MalfunctionJun 26, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY ARTERY. AN 8X80X120 EPIC¿ VASCULAR STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. WHEN THE DEVICE WAS WITHDRAWN, IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS NOT COMPLETED AS PER PATIENT'S REQUEST. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638089 ↗
• InjuryMay 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THE STENT WAS THE WRONG SIZE. THE TARGET LESION WAS LOCATED IN AN 85% STENOSED AND SEVERELY TOURTOUS LEFT LEG ILIAC ARTERY. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE PRE-DILATED LESION. A 6F NON BSC SHEATH AND A 5F NON BSC GUIDE CATHETER WERE ADVANCED. THE TARGET LESION WAS THEN SUBSEQUENTLY TREATED WITH AN EPIC¿ VASCULAR 8X80X120MM STENT. DURING DEPLOYMENT THE STENT DEPLOYED THE FIRST 2CM NORMAL. HOWEVER, THE PHYSICIAN FOUND THE REST OF LENGTH OF DEPLOYED STENT WAS SHORTER THAN EXPECTED. THE DEPLOYED STENT WAS NO MORE THAN 5 CM LONG AND THE LESION WAS NOT FULLY COVERED. THE PHYSICIAN THEN SELECTED A 8X10MM NON BSC STENT TO COVER THE REMAINDER OF THE LESION. THE PROCEDURE WAS COMPLETED BY POST-DILATING THE STENT WITH A MUSTANG BALLOON CATHETER. THE PATIENT WAS STABLE WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582745 ↗
• MalfunctionMay 21, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS PROTRUDING. AN EPIC¿ VASCULAR STENT 8X80X120 WAS SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE ILIAC VEIN FOR A MODERATELY CALCIFIED LESION WITH 99% STENOSIS. DURING UNPACKING, IT WAS NOTED THAT THE STENT WAS PROTRUDING FROM THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6580775 ↗
• MalfunctionApr 26, 2017Device Damaged Prior to Use; Activation, Positioning or Separation Problem; Device Damaged Prior to Use; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. A 8X80X120 EPIC¿ VASCULAR STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION AND UPON FLUSHING, THE PHYSICIAN NOTED THAT THE DISTAL STENT STRUTS WAS EXPOSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6522459 ↗