Epic™ Vascular H74939200081020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729805564), received between Dec 16, 2016 and Jan 22, 2025 — classified as 1 death, 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 22, 2025Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST AND HYPOTENSION REQUIRING ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT ENDOVASCULAR REPAIR UNDER LOCAL ANESTHESIA. THE 60% STENOSED AND OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED COMMON ILIAC ARTERY, EXTERNAL ILIAC ARTERY, AND MID TO DISTAL END SUPERFICIAL FEMORAL ARTERY. AFTER GAINING VASCULAR ACCESS WITH A 5F FEMORAL ARTERY PUNCTURE SHEATH, A V-18 GUIDEWIRE WAS ADVANCED FOLLOWED BY PLACING A 6F 45CM SHEATH. PREDILATATION WAS PERFORMED USING AN 8X80 MUSTANG BALLOON FOLLOWED BY ADVANCING AN 8X100X120 EPIC VASCULAR SELF-EXPANDING STENT; HOWEVER, RESISTANCE WAS FELT DURING INTRODUCTION AND THE STENT COULD NOT REACH THE LESION SITE. DURING WITHDRAWAL, SIGNIFICANT RESISTANCE WAS NOTED AND THE PHYSICIAN APPLIED SIGNIFICANT FORCE. AFTER REMOVAL, IT WAS NOTED THAT THE STENT DELIVERY SHAFT AND THE MIDDLE SECTION OF THE STENT WAS KINKED WHICH LED TO CROSSING FAILURE. THE PATIENT IS OLDER AND HAD SUFFERED MULTIPLE UNDERLYING DISEASES, AND AT THIS POINT, THE PATIENT HAD A CARDIAC ARREST DUE TO DROP IN BLOOD PRESSURE. THE PHYSICIAN CARRIED OUT A SERIES OF FIRST-AID COMPRESSIONS. THE PATIENT'S

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 21211603 ↗
• DeathFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. ON (B)(6) 2021, THE PATIENT PRESENTED DUE TO UPPER GASTROINTESTINAL BLEEDING AND TIPS (TRANS INTRAHEPATIC PORTAL SHUNT) WAS PERFORMED, AND THE PROCEDURE WAS SUCCESSFUL. ON (B)(6) 2022, COMPUTED TOMOGRAPHY REVEALED THAT THE STENT WAS FRACTURED. AT THE TIME OF THE REPORT, THERE WERE NO OBVIOUS SYMPTOMS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446080 ↗
• MalfunctionMar 8, 2019Activation, Positioning or Separation Problem; Mechanical Jam; Activation, Positioning or Separation Problem; Mechanical Jam

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. AN EPIC VASCULAR STENT WAS SELECTED FOR USE FOR A BALLOON DILATION AND PERCUTANEOUS INTERVENTIONAL PROCEDURE OF THE ILIAC ARTERY IN THE RIGHT LOWER EXTREMITY TO TREAT ARTERIAL STENOSIS. THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE LESION USING THE THUMBWHEEL, HOWEVER, THE THUMBWHEEL COULD NO LONGER BE USED AFTER THE TOP OF THE STENT WAS DEPLOYED. THE PHYSICIAN THEN WITHDREW THE ENTIRE STENT DELIVERY SYSTEM COMPLETELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED A LITTLE, AND THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALLS. THERE WAS NO STENT DAMAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8403495 ↗
• MalfunctionDec 16, 2016Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 8X100X120 EPIC¿ VASCULAR STENT WAS BEING DEPLOYED, HOWEVER, THE STENT WAS DIFFICULT TO DEPLOY AND GOT STUCK HALFWAY THROUGH DEPLOYING IT. THE PHYSICIAN WAS ABLE TO FULLY DEPLOY THE STENT. UPON WITHDRAWING THE CATHETER, IT WAS NOTED THE INNER PART OF THE WHITE TUBING GOT STUCK ON THE GUIDEWIRE. THE CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. BECAUSE WIRE ACCESS WAS LOST, THE CASE WAS ENDED PREMATURELY WITHOUT POST DILATING THE IMPLANTED STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6180824 ↗