Epic™ Vascular H74939200106020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805045), received between Jun 19, 2018 and Dec 19, 2022 — classified as 1 injury, 2 malfunctions.

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 16, 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 19, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND SHAFT KINK WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 10X60X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT FAILED TO CROSS THE LESION AND A SHAFT KINKED WAS NOTICED POST PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A 10X40X120 EPIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008670 ↗
• MalfunctionJul 20, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA UPPER ARM APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT ILIAC ARTERY. A 10 X 60 X 120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. AFTER TREATING THE DISTAL PART WITH THE 0.014 SYSTEM, IT WAS REPLACED WITH A 0.035 NON-BSC GUIDEWIRE. UPON REMOVAL OF THE STENT DELIVERY SYSTEM AFTER STENT IMPLANTATION, THE GUIDEWIRE AND EPIC SYSTEM WAS STUCK. THE ENTIRE SYSTEM WAS REPLACED AND A NEW GUIDEWIRE WAS THEN RE-INSERTED. THE STENT WAS POST DILATED WITH A BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PROBLEM WITH THE PATIENT, AND THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197192 ↗
• InjuryJun 19, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT POSITIONING/PLACEMENT PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT EXTERNAL ILIAC ARTERY. A 10X60X120 EPIC¿ VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT THE DELIVERY SYSTEM MOVED FORWARD CAUSING TO MISS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613415 ↗