Epic™ Vascular H74939200074070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729805458), received between Jun 4, 2018 and Mar 23, 2022 — classified as 2 injuries, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT PROFILE PROBLEM AND HEMATOMA OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED EXTERNAL ILIAC ARTERY. A 7X40X75 EPIC VASCULAR STENT WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, THE STENT WAS SUDDENLY SHORTENED FROM THE PART WHERE ABOUT 2CM WAS LEFT. THE LESION COULD NOT BE COVERED AND A HEMATOMA DEVELOPED ON THE PERIPHERAL SIDE. SUBSEQUENTLY, A 7X80 STENT WAS PLACED OVERLAPPING INTO THE PERIPHERY FROM THE FIRST STENT, AND BLOOD FLOW WAS ABLE TO BE SECURED SUCCESSFULLY. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 13860530 ↗
• MalfunctionMay 15, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE AN ILIAC VEIN. FOLLOWING DILATATION WITH A BALLOON CATHETER, A 7X40X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT WAS KINKED AND COULD NOT BE DEPLOYED. THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY ROTATING THE THUMB WHEEL BUT THE MARKER DID NOT MOVE. UPON ROTATING THE THUMB WHEEL SEVERAL TIMES, THE MARKER MOVED FOR SEVERAL MILLIMETERS AND THE STENT WAS DEPLOYED PARTIALLY. THE DEVICE WAS REMOVED AS THE STENT WAS NOT DEPLOYED AS MUCH AS THE THUMB WHEEL ROTATED. THE LESION WAS DILATED WITH THE BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061577 ↗
• MalfunctionSep 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT INNER SHAFT/SHEATH DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING AN IPSILATERAL FEMORAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED COMMON ILIAC ARTERY. AFTER A GUIDE WIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED. A 7X40X75MM EPIC VASCULAR STENT WAS PLACED WITHOUT PROBLEM. WHEN THE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY, THE INNER SHEATH WAS COMPLETELY REMOVED OR PULLED OUT FROM THE OUTER OF THE DEVICE. NO DETACHMENT OCCURRED INSIDE THE PATIENT'S BODY. THE DEVICE WAS ORIGINALLY HAD STOPPER APPLIED BUT THE STOPPER DID NOT FUNCTION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886384 ↗
• InjuryJun 4, 2018Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. A 7X40X75 EPIC¿ VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, POST STENT DEPLOYMENT, IT WAS NOTED THAT THE EDGE OF THE STENT STRUTS WERE LIFTED. A NON-BSC STENT WAS THEN DEPLOYED AS ADDITIONAL TREATMENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566171 ↗