Epic™ Vascular H74939200081070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729805571), received between Nov 27, 2017 and Sep 28, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-SEP-2020. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED SHUNT. AN 8X100X75MM EPIC STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS TAKEN OUT, THE SHAFT WAS FOUND BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT PARTIAL DEPLOYMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10593192 ↗
• InjuryMay 29, 2018Detachment Of Device Component; Detachment Of Device Component

  SAME CASE AS MDR ID: 2134265-2018-05320. IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT COMMON ILIAC ARTERY AND THE THROMBOSED PREVIOUSLY PLACED WALLSTENT IN THE EXTERNAL ILIAC ARTERY (EIA). THE WALLSTENT OF EIA AND BLOOD VESSEL WERE TORTUOUS TO AN UNBELIEVABLE EXTENT. A NON-BSC GUIDE WIRE WAS ADVANCED VIA RIGHT FEMORAL APPROACH BUT FAILED TO CROSS. THE DEVICE WAS THEN ADVANCED VIA LEFT FEMORAL BUT IT WAS STILL UNABLE TO CROSS. SUBSEQUENTLY, WITH THE AID OF A NON-BSC SHEATH, THE WIRE WAS ADVANCED VIA LEFT BRACHIAL BUT STILL FAILED. APPROACH WAS PERFORMED AGAIN VIA LEFT FEMORAL AND THE GUIDE WIRE WAS ABLE TO CROSS. A 3MM-20MM STERLING BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. FOLLOWING PLAIN OLD BALLOON ANGIOPLASTY WITH A 6MM-60MM STERLING BALLOON CATHETER, A 8X100X75 EPIC¿ VASCULAR STENT WAS PLACED. UPON REMOVING THE STENT DELIVERY SYSTEM (SDS) POST-DEPLOYMENT, RESISTANCE WAS ENCOUNTERED. WHEN THE DEVICE WAS PULLED, A SNAPPING SOUND WAS HEARD. THE SDS WAS REMOVED, HOWEVER; IT WAS NOTICED THAT THE TIP GOT DETACHED AND THE DETACHED FRAGMENT COULD NOT BE FOUND. THE PHYSICIAN ATTEMPT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7548569 ↗
• InjuryNov 27, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID 2134265-2017-11238. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. ON AN UNSPECIFIED DATE, AN EPIC STENT WAS IMPLANTED TO TREAT A TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IN (B)(6) 2017, THE PATIENT PRESENTED FOR TREATMENT OF THE 100% RESTENOSED 8X100X75 EPIC¿ VASCULAR STENT LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED SFA. A 7.0MMX40MMX135 CM (4F) STERLING¿ BALLOON CATHETER WAS ADVANCED FOR DILATATION. UPON INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: Reocclusion

  MAUDE report 7059500 ↗