Epic™ Vascular H74939200078070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805533), received between May 3, 2017 and Oct 11, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT INNER SHAFT AND OUTER SHEATH DETACHMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 7X80X75 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM AFTER STENT DEPLOYMENT, THE INNER SHAFT AND OUTER SHEATH WERE REMOVED SEPARATELY. THE INNER SHAFT WAS SEPARATED WHEN THE OUTER SHEATH PART CAME OUT OF THE SHEATH. THE INNER SHAFT WAS ALSO PULLED OUT OF THE SHEATH BUT HAD STAYED ON THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580983 ↗
• InjuryMay 3, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES AND STENT DAMAGE OCCURRED. THE 99% STENOSED AND MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE UPPER ARM. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS BEING PERFORMED; AN UNKNOWN MANUFACTURER¿S GUIDEWIRE CROSSED THE LESION VIA THE VEINOUS ANTEGRADE APPROACH. PRE-DILATION WAS PERFORMED WITH A NON BSC BALLOON CATHETER, HOWEVER, DILATION WAS NOT SATISFACTORY AND A 7X80X75MM EPIC¿ VASCULAR STENT WAS ADVANCED. DURING DEPLOYMENT OF THE EPIC¿ STENT, THE PHYSICIAN EXPERIENCED DEPLOYMENT DIFFICULTY IN THE HANDLE'S DEPLOYMENT DIAL. THE STENT OPENED 2-3CM FROM THE TIP AND THE PHYSICIAN THEN DEPLOYED THE STENT WITH TENSION BY PULLING. THE STENT DEPLOYED WITH ABOUT 2 STRUTS BENT INWARD. ANGIOGRAPHY WAS PERFORMED AND FLOW WAS LIMITED, SUBSEQUENTLY A NON BSC BALLOON CATHETER WAS DELIVERED BUT IT WAS UNABLE TO PASS THROUGH THE EPIC¿ VASCULAR STENT. DILATION WAS THEN PERFORMED INSIDE THE EPIC¿ VASCULAR STENT WITH ANOTHER NON BSC BALLOON CATHETER. STENT IN STENT PLACEMENT WAS PERFORMED USING A 6X24MM WALLSTENT. FLOW WAS RECOVERED FOLLOWING POST DILATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540866 ↗