Epic™ Vascular H74939200086020Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729805687), received between Jan 30, 2017 and Nov 28, 2023 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09NOV2023. IT WAS REPORTED THAT THE SHAFT WAS KINKED AND DAMAGED. AFTER UNPACKING AN 8X60X120 EPIC VASCULAR STENT, IT WAS OBSERVED THAT THE SHAFT CATHETER WAS KINKED AND DAMAGED AND COULD NOT BE IMPLANTED. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222541 ↗
• InjurySep 6, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT KINK OCCURRED AND THE PATIENT EXPERIENCED DISCOMFORT. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 8 X 60 X 120 EPIC VASCULAR STENT WAS ADVANCED ALONG WITH THE NON-BOSTON SCIENTIFIC WIRE TO CROSSOVER THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOT SMOOTH, AND SOME DISCOMFORT ENCOUNTERED AROUND THE STEEP BIFURCATION. THE DEVICE WAS THEN REMOVED, AND IT WAS FOUND A SLIGHTLY BENT OR DENT LIKE A KINK WAS NOTED ON THE DEVICE. THE STENT WAS REPLACED WITH A DIFFERENT DEVICE FOR SAFETY MEASURES AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Discomfort

  MAUDE report 17692483 ↗
• MalfunctionMay 1, 2023Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. DURING UNPACKING OF AN 8X60X120 EPIC VASCULAR STENT, IT WAS NOTED THAT THE TIP OF THE STENT HAVE ALREADY DEPLOYED HALFWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843362 ↗
• MalfunctionNov 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY OF LOWER EXTREMITY. A 8X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE STENT STRUTS WERE FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825272 ↗
• MalfunctionOct 18, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. A 8X60X120 EPIC VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624164 ↗
• InjuryJan 22, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING A CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED EXTERNAL ILIAC ARTERY. A 8X60X120 EPIC STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN ADVANCED THE DEVICE TO THE LESION AND INITIATED THE DEPLOYMENT OF THE STENT. DURING DEPLOYMENT THE STENT DISLODGED IN THE AORTA VENTRALIS. AN ADDITIONAL STENT WAS THEN PLACED IN THE AORTA VENTRALIS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617205 ↗
• MalfunctionDec 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 8X60X120 EPIC VASCULAR STENT WAS UNPACKED. HOWEVER, DURING PREPARATION, IT WAS FOUND THAT THE FRONT END OF THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395471 ↗
• MalfunctionMay 13, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT WAS PARTLY INADVERTENTLY DEPLOYED. AN 8X60X120MM EPIC STENT WAS PREPARED FOR USE. HOWEVER, WHEN THE DEVICE WAS CHECKED DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS PROTRUDING SEVERAL MILLIMETERS FROM THE TIP WITHOUT MANIPULATION OF THE DEPLOYMENT MECHANISM. THE PROCEDURE WAS COMPLETED WITH AN 8MMX8MM EPIC STENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604994 ↗
• MalfunctionJun 20, 2017Detachment Of Device Component; Device Damaged Prior to Use; Detachment Of Device Component; Device Damaged Prior to Use

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. AN 8X60X120 EPIC¿ VASCULAR STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE DELIVERY SYSTEM WAS DETACHED. THE DEVICE WAS NEVER USED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6654077 ↗
• MalfunctionFeb 6, 2017Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13JAN2017. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. A 8X60X120 EPIC¿ VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT COULD NOT BE RELEASED BY PULL GRIP. THE DEVICE WAS REMOVED FROM THE PATIENT . THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER RETURNED DEVICE ANALYSIS REVEALED THAT THE STENT WAS INADVERTENTLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6305789 ↗
• MalfunctionJan 30, 2017Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. A 8 X 60 X 120 EPIC VASCULAR STENT WAS SELECTED TO TREAT THE LESION. PREDILATION WAS PERFORMED, HOWEVER DURING PREPARATION OF THE DEVICE, IT WAS NOTED THAT THE TOP OF THE STENT WAS SHIFTED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 6285835 ↗