Epic™ Vascular H74939200061020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729805205), received between May 30, 2018 and Apr 26, 2024 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionApr 26, 2024Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT STENT MIGRATED AND DID NOT FULLY COVER THE STENOSIS. THE PATIENT WAS PRESENTED WITH LEFT FEMORAL ARTERY OCCLUSION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X100X120 EPIC VASCULAR WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DIFFICULT TO DELIVER TO THE TARGET POSITION. WHEN DEPLOYED, IT WAS NOTED THAT THE STENT MIGRATED AND DID NOT FULLY COVER THE STENOSIS. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190875 ↗
• MalfunctionMar 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X100X120 EPIC VASCULAR STENT WAS DEPLOYED AND POST-DILATED WITH A NON-BOSTON SCIENTIFIC BALLOON; HOWEVER, A VISIBLE SIZE DIFFERENCE BETWEEN THE STENT AND A PREVIOUSLY DEPLOYED 6X150 STENT IN THE DISTAL SFA WAS NOTED. THE PHYSICIAN BELIEVES THAT THE DEPLOYED STENT HAD AN INCORRECT SIZE. THE STENT REMAINED IMPLANTED; HOWEVER, THE STENT DID NOT FULLY COVER TARGET LESION. THE PROCEDURE WAS COMPLETED. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985381 ↗
• InjuryAug 16, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ARTERY. A 6X100X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT WAS FORESHORTENED AND WAS STUCK IN THE CENTER AREA AND MISSED THE TARGET LESION. THE PHYSICIAN EXTENDED THE STENT AND ADDED AN ADDITIONAL STENT TO THE STACKED AREA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325599 ↗
• InjuryOct 30, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT DID NOT FULLY EXPAND POST DEPLOYMENT. THE TARGET LESION WAS IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6X100X120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT THE PROXIMAL END OF THE STENT STARTED TO STACK AND WAS DEPLOYING WITHIN ITSELF. SUBSEQUENTLY, A BALLOON WAS INFLATED AND DRAGGED WITHIN THE STENT TO REMEDY THE PROXIMAL END OF THE STENT. THE STENT DELIVERY SYSTEM WAS REMOVED AND THERE WAS NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9255409 ↗
• InjuryMay 30, 2018Bent; Break; Bent; Break

  IT WAS REPORTED THAT STENT DAMAGE AND FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING RETROGRADE APPROACH FROM THE FOOT. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6X100X120 EPIC¿ VASCULAR STENT WAS ADVANCED THROUGH THE HUNTERS CANAL BACK PROXIMAL TO LOWER MID SFA THROUGH THE SEGMENT WHERE THE CTO WAS CROSSED EARLIER BY THE RETROGRADE APPROACH. THE CTO SEGMENT WAS HYPER-DILATED FOR THE NATURE OF THE CTO. THE PHYSICIAN SLOWLY FLOWERED OPEN THE EPIC DISTALLY AND ONCE ANCHORED, CONTINUED TO THUMBWHEEL RELEASE THE STENT. AT WHICH POINT THE STENT STARTED TO QUICKLY FORESHORTEN IN THE ECTATIC AREA. THE STENT THEN APPEARED TO INVAGINATE ON ITSELF AND POSSIBLY FRACTURED IN THAT SEGMENT. THE LESION WAS A CALCIFIED CTO, HOWEVER, THE LOCATION WHERE THE STENT HAD AN ISSUE WAS A VERY DILATED AREA. A 5X200 CHARGER PTA BALLOON CATHETER WAS INITIALLY ADVANCED FROM THE TRADITIONAL APPROACH BUT FAILED TO CROSS AS THE STENT WAS NOT ALLOWING PASSAGE IN THAT DIRECTION. THEREFORE AN ADDITIONAL 5X100 STERLING BALLOON CATHETER WAS THEN ADVANCED FROM THE FOOT TO CROSS AND POST-DILATE THE STENT. THE PROCEDUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7555360 ↗