Epic™ Vascular H74939200061220Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729805229), received between Apr 6, 2017 and Jan 23, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 90% SEVERE STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT FEMORAL ARTERY. THE PATIENT WAS IN A SUPINE POSITION, WHOSE RIGHT FEMORAL ARTERY WAS PUNCTURED. AFTER A 7F NON-BOSTON SCIENTIFIC (BSC) PUNCTURE SHEATH WAS DELIVERED AND 0.035 AMPLATZ GUIDE WIRE CROSSED THE LESION, A 6 X 120 X 120 EPIC VASCULAR STENT WAS ADVANCED FOR TREATMENT. THE STENT REACHED THE LESION, OF WHICH THE TIP WAS DEPLOYED BY ROLLING THE SHAFT. HOWEVER, AFTER THAT, ANGIOGRAPHY SHOWED THAT THE STENT COULD NOT CONTINUE TO BE DEPLOYED EVEN AFTER MULTIPLE ATTEMPTS. LATER, THE 7F NON-BSC SHEATH WAS ADVANCED, AND THE STENT WAS COMPLETELY RECAPTURED INTO THE SHEATH. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230378 ↗
• InjuryNov 21, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT POSITIONING/PLACEMENT PROBLEMS WERE ENCOUNTERED. THE LESION WAS MILDLY CALCIFIED, NON-TORTUOUS AND WAS LOCATED IN TWO SPOTS WITHIN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. AFTER LASER ATHERECTOMY TREATMENT AND BALLOONING, A 6MM X 120MM EPIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT JUMPED FORWARD AND WAS DEPLOYED DISTAL TO THE LESION SITE. THE STENT WAS FULLY DEPLOYED AND WELL APPOSED TO THE VESSEL. SUBSEQUENTLY, A 6X80MM AND A 6X120MM INNOVA STENTS WERE DEPLOYED TO THE LESION WITH GOOD RESULT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834951 ↗
• InjuryNov 26, 2019Activation Failure; Activation Failure

  IT WAS REPORTED THAT STENT DID NOT FULLY EXPAND. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY. A 6X120X120MM EPIC STENT WAS SELECTED FOR TREATMENT. AFTER THE STENT WAS DEPLOYED, IT WAS OBSERVED THAT IT WAS NOT FULLY EXPANDED. A BALLOON CATHETER WAS ADVANCED THROUGH THE STENT AND INFLATED TO EXPAND THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379322 ↗
• MalfunctionApr 26, 2019Premature Activation; Material Integrity Problem; Premature Activation; Material Integrity Problem

  IT WAS REPORTED THAT INADVERTENT DEPLOYMENT OCCURRED. A 6 X 120 X 120 EPIC VASCULAR STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, WHEN THE STENT WAS OPENED, A MALFUNCTIONED TIP WAS NOTED. THE DEVICE WAS ALREADY DEPLOYED AND NEVER TOUCHED THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8556763 ↗
• InjurySep 7, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 120 X 120 MM EPIC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, STENT FORESHORTENING ABOUT 2-3 CM FROM THE PROXIMAL FINISHING SEGMENT OF THE LESION WAS OBSERVED. IT WAS DETERMINED BY MARKED SCREEN FOR PLACEMENT AND ESTIMATED BY THE PHYSICIAN UNDER FLUOROSCOPY. ANOTHER 6X40 EPIC STENT WAS PULLED OUT TO COVER THE AREA THAT WAS MISSED. FOLLOWING POST DILATATION, THE STENT WAS WELL POSITIONED, APPOSED AND FULLY EXPANDED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED WITH NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855102 ↗
• MalfunctionJul 20, 2018Premature Activation

  IT WAS REPORTED THAT STENT INADVERTENT DEPLOYMENT OCCURRED. A 6X120X120MM EPIC¿ VASCULAR STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE STENT WAS PULLED OUT OF THE PACKAGING AND RIGHT BEFORE LOADING THE STENT ONTO THE WIRE, IT WAS NOTED THAT THE STENT WAS ALREADY PRE-DEPLOYED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7706866 ↗
• MalfunctionNov 20, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT INADVERTENT STENT DEPLOYMENT OCCURRED. DURING PREPARATION FOR A STENT TREATMENT PROCEDURE WITHIN THE ILIAC VEIN, THE 6X120X120 EPIC VASCULAR STENT DEPLOYED ON THE TABLE OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7045707 ↗
• InjuryMay 22, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS USED TO GAIN ACCESS TO THE TARGET LESION AND A 6X120X120MM EPIC¿ VASCULAR STENT WAS ADVANCED OVER A STEEP BIFURCATION IN THE ILIAC ARTERY. DURING ADVANCEMENT THE CATHETER SHAFT KINKED AND THE OUTER SHEATH WAS UNABLE TO BE REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE AD INITIATED STENT DEPLOYMENT. DURING DEPLOYMENT THE STENT WAS OBSERVED TO BE SHORTENING AS IT WAS DEPLOYING. IN ATTEMPTS TO STRAIGHTEN THE STENT THE PHYSICIAN STRETCHED THE STENT DELIVERY CATHETER SHAFT BY APPLYING TENSION; HOWEVER, THE STENT SHORTENING ISSUE WAS NOT RESOLVED AND THE STENT WAS SHORTENED AS IT WAS IMPLANTED. AS A RESULT OF THE SHORTENED STENT THE LESION WAS NOT FULLY COVERED AND ADDITIONAL STENTING WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582710 ↗
• InjuryApr 6, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X120X120 EPIC¿ VASCULAR STENT WAS IMPLANTED. THE PHYSICIAN HAD FORWARD PRESSURE ON THE DEVICE AT THE TIME OF DEPLOYMENT CREATING THE STENT TO BUNCH UP. THE STENT WAS THEN "SMOOTHED OUT" BY A POST DILATION BALLOON AND ANOTHER 6X80 EPIC¿ VASCULAR STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463471 ↗