Epic™ Vascular H74939200074020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805441), received between Aug 1, 2017 and Aug 11, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. A 7X40X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT SLIP DOWN STREAM AND DISTALLY MIGRATED AFTER INITIAL IMPLANT. BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307490 ↗
• InjuryMar 12, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING DIFFICULTIES WERE ENCOUNTERED REQUIRING AN ADDITIONAL STENT TO BE PLACED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 7X40X120MM EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT JUMPED FORWARD PASSED THE STENOSIS AFTER IT WAS ALMOST FULLY DEPLOYED. ANOTHER OF THE SAME STENT WAS USED TO STENT THE STENOSIS. NO PATIENT COMPLICATIONS WERE REPORTED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823325 ↗
• InjuryAug 1, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTIES OCCURRED. AN 7X40X120 EPIC¿ STENT WAS SELECTED TO TREAT A LESION LOCATED IN THE ILIAC ARTERY. AS THE EPIC¿ STENT WAS DEPLOYED THE STENT JUMPED OUT OF POSITION. ADDITIONAL STENTING OF THE SAME DEVICE WAS REQUIRED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757303 ↗