Epic™ Vascular H74939200071070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729805557), received between Nov 17, 2017 and Mar 22, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 7X100X75 EPIC VASCULAR STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE AND THE STENT COULD NOT BE DEPLOYED SINCE IT WAS FORCED THROUGH SEVERE CALCIFICATION. THE DEVICE WAS REMOVED AND CAME OUT NORMALLY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE STENT WAS SUBSEQUENTLY DEPLOYED OUTSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593779 ↗
• MalfunctionJan 11, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE UPPER ARM. A 7X100X75MM EPIC STENT WAS SELECTED TO OVERLAP A PREVIOUSLY PLACED 7.0X40 EPIC STENT ON THE CENTRAL SIDE. THE STENT WAS POSITIONED AND DEPLOYED WITHOUT ISSUES. AFTER DEPLOYMENT, THE STENT LENGTH MEASURED TO BE 124MM. THE INTENDED TREATMENT WAS COMPLETED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11152039 ↗
• MalfunctionJan 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC TO EXTERNAL ILIAC ARTERY. FOLLOWING PRE-DILATION WITH A BALLOON CATHETER, A 7X100X75MM EPIC STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT WAS ELONGATED. THE DEVICE WAS REMOVED TOGETHER WITH THE SHEATH AND FLUOROSCOPIC IMAGES WAS PERFORMED, THERE WAS NO SEGMENT OR PART OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209440 ↗
• InjuryOct 18, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE 80% RE-STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN. AFTER A 7X100X75 EPIC STENT WAS IMPLANTED, IT WAS NOTED THAT THE STENT FORESHORTENED FOR ABOUT 6CM CAUSING VESSEL OBSTRUCTION. FURTHER DEVICES WERE UNABLE TO PASS THROUGH. THE PATIENT WAS SENT FOR SURGERY AND GRAFT REPLACEMENT WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7978758 ↗
• InjuryNov 17, 2017Bent; Device Slipped; Activation, Positioning or Separation Problem; Bent; Device Slipped; Activation, Positioning or Separation Problem

  IT WAS REPORTED THERE WAS POSITIONING PLACEMENT ISSUES WHICH CAUSED THE STENT TO DEPLOY PREMATURELY WITH PROFILE PROBLEMS. THE PHYSICIAN WAS PERFORMING A STENTING TREATMENT PROCEDURE IN A 90% STENOSED, APPROXIMATELY 6MM, MODERATELY TORTUOUS, MILDLY CALCIFIED BIFURCATION BETWEEN THE INTERNAL ILIAC ARTERY AND EXTERNAL ILIAC ARTERY. DURING THE ADVANCEMENT OF THE 7X100X75 EPIC VASCULAR STENT, THE DELIVERY SYSTEM "JUMPED" PAST THE INTENDED DEPLOYMENT SITE AND WAS UNINTENTIONALLY PARTIALLY DEPLOYED. THE STENT WAS PUSHED AND SHORTENED FROM 10CM TO 4CM. THE PHYSICIAN IMPLANTED ANOTHER 7X80 EPIC STENT TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS AND NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7042189 ↗