Epic™ Vascular H74939200098070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729805878), received between Jan 21, 2021 and Feb 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 12, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 035 NON-BOSTON SCIENTIFIC GUIDEWIRE WAS DELIVERED INTO THE LESION AND A 9X80X75 EPIC VASCULAR SELF-EXPANDING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE WIRE AND THE BALLOON BECOME STUCK TOGETHER. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE FROM THE PATIENT, BUT THE RESISTANCE WAS STRONG. IT WAS NOT CONFIRMED IF THE STENT WAS KINKED, BUT THE TIP WAS NOTED SLIGHTLY LIFTED. THE WIRE AND THE STENT WERE REMOVED TOGETHER FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686533 ↗
• MalfunctionJan 16, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. AFTER GUIDEWIRE CROSSED THE LESION, A 9X80X75 EPIC STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS. THE STENT WAS CHANGED TO A BIGGER SIZE. PRE-DILATION WITH A STERLING MR 5.0-40 BALLOON AND DILATION DONE WITH A NON-BSC THAT WAS 6MM IN DIAMETER WERE PERFORMED AND ADVANCED, BUT THE DEVICE COULD STILL NOT CROSS. GUIDEWIRE WAS CHANGED TO 0.035 THREE TIMES BUT STENT WOULD STILL NOT CROSS. WHEN ATTEMPTED TO ADVANCE BY PUSHING INTO THE AORTA SIDE, IT WAS OBSERVED TO HAVE BEEN SLIGHTLY SEPARATED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT WAS IN A STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521766 ↗
• MalfunctionOct 12, 2023Positioning Failure; Difficult to Remove; Material Deformation; Positioning Failure; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THERE WAS A DIFFICULTY IN REMOVING THE DEVICE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED EXTERNAL ILIAC ARTERY. A 9X80X75 EPIC VASCULAR STENT WAS USED FOR TREATMENT. HOWEVER, WHEN THE WHEEL WAS ROTATED TO CHECK IF IT CAN BE DEPLOYED, RESISTANCE WAS FELT DUE TO THE CALCIFIED LESION DURING BOTH REMOVAL AND INSERTION. PHYSICIAN WAS ABLE TO REMOVE THE DEVICE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927317 ↗
• MalfunctionJan 21, 2021Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JAN-2021. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER THE GUIDEWIRE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY TO EXTERNAL ILIAC ARTERY. A 9X80X75 EPIC VASCULAR STENT WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE OUTSIDE THE PATIENT'S BODY, BUT RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11207721 ↗