Epic™ Vascular H74939200091070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805892), received between Jun 28, 2018 and Dec 22, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY IN REMOVING FROM GUIDEWIRE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. AFTER CROSSING THE LESION WITH A NON-BSC GUIDEWIRE, A 9 X 100 X 75 EPIC STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. AN ATTEMPT TO WITHDRAW THE DELIVERY SYSTEM WAS MADE, BUT IT WAS DIFFICULT TO REMOVE AND WAS STUCK TOGETHER WITH THE NON-BSC GUIDEWIRE. BOTH DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383876 ↗
• MalfunctionNov 18, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-NOV-2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND KINK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED EXTERNAL ILIAC ARTERY. FOLLOWING A 6F INTRODUCER SHEATH WAS PLACED, A .035 NON-BSC GUIDEWIRE WAS CROSSED THE LESION. PRE-DILATION WAS PERFORMED RESULTING TO A 60% RESIDUAL STENOSIS. A 9X100X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE UNABLE TO CROSS THE LESION AND KINK WAS NOTED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DEPLOYED OUTSIDE OF THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836349 ↗
• InjuryJun 28, 2018Bent; Migration or Expulsion of Device; Bent; Migration or Expulsion of Device

  IT WAS REPORTED THAT STENT DAMAGE AND MIGRATION OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. AFTER PRE-DILATION, A 9X100X75MM EPIC¿ VASCULAR STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, WHEN PHYSICIAN TRIED TO ADVANCE THE SHEATH FURTHER WHILE USING DILATOR, IT WAS NOTED THAT THE EDGE OF THE STENT WAS CAUGHT IN THE GAP AND GOT FLATTENED. UPON PUSHING FURTHER, THE STENT SHIFTED. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER STENT INSIDE THE EPIC STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE FLOW UNTIL THE DISTAL WAS ALSO GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7647823 ↗