EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013901), received between Apr 23, 2018 and Jul 12, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 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.

• InjuryJul 12, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  INITIAL COMPLAINT, RECEIVED ON JUNE 19, 2018: THE PHYSICIAN WAS USING AN ELUNIR THROUGH CALCIFIC ANATOMY AND THE STENT SCRAPPED OFF THE BALLOON PREMATURELY. THE PHYSICIAN WAS ABLE TO FIND THE STENT IN THE PATIENTS ARTERY, BLEW UP A SMALL BALLOON TO CATCH IT, AND PULLED IT INTO THE GUIDE CATHETER WHERE HE SNARED IT AND BROUGHT IT OUT OF THE PATIENT. THERE WAS NO LASTING HARM TO THE PATIENT. ADDITIONAL INFORMATION, RECEIVED ON JUNE 20, 2018: THE TARGET SITE WAS PROXIMAL RCA. THE TARGET VESSEL WAS CALCIFIED AND TORTUOUS AND THE STENOSIS PERCENTAGE WAS:60%+. THE ACCESS SITE WAS RADIAL. THE SHEATH USED WAS 6F, TERUMO PINNACLE. THE USED GUIDE CATHETER SIZE WAS 6F THE STENT WAS NOT MANIPULATED DURING THE PREP AND PERFORMED PER THE IFU, HOWEVER, THE PHYSICIAN INSTRUCTED THE TECHNICIAN TO PULL NEGATIVE ON THE BALLOON PRIOR TO INSERTING INTO THE SHEATH. IT DIDN'T CROSS. THE STENT WAS REMOVED AND THEN PULLED NEGATIVE AGAIN. THIS HAPPENED 3 TIMES. ON (B)(6) TIME THEY REALIZED THE STENT WASN'T ON THE BALLOON. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681019 ↗
• InjuryApr 23, 2018Difficult to Remove; Difficult to Remove

  AFTER SUCCESSFULLY DEPLOYING THE ELUNIR 4.0 X 20MM STENT, THE STENT BALLOON WAS USED TO POST-DILATE THE PROXIMAL PORTION OF THE STENT. WHEN THE BALLOON WAS ABOUT TO BE REMOVED AFTER POST-DILATATION, IT GOT STUCK INTO THE WIRE. IT SEEMED LIKE THE BALLOON AND THE WIRE WERE FUSED TOGETHER. BOTH THE WIRE AND THE BALLOON WERE EVENTUALLY REMOVED AND BOTH ITEMS (BMW WIRE AND THE ELUNIR STENT) WILL BE RETURNED FOR EVALUATION. NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED ON MARCH 09, 2018: THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU); THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE; THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING; THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH WERE NOT RESTERILIZED; THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU); NO ANOMALIES WERE NOTED DURING OR AFTER THE DEVICE WAS PREPPED; IT WAS VERIFIED PRIOR TO INSERTION THAT STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM; THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE; THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT; ADD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7449967 ↗