EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013734), received between Apr 29, 2018 and Jun 17, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 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.

• InjuryJun 17, 2018Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THE STENT WAS USED IN A CALCIFIED ARTERY. THE PHYSICIAN COULD NOT DELIVER THE STENT SO SHE PULLED BACK INTO THE GUIDE AND THE STENT WAS DISLODGED. THE PHYSICIAN HAD TO FISH IT OUT WITH A BALLOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7608484 ↗
• MalfunctionApr 29, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  INFORMATION RECEIVED ON MAR 18, 2018: NO CROSS OF AN ELUNIR STENT; PHYSICIAN CHOSE ANOTHER STENT THAT CROSSED SUCCESSFULLY; PATIENT TREATED AND RELEASED; NO PATIENT INJURY. DEVICE IS NOT AVAILABLE. INFORMATION RECEIVED ON MAR 27, 2018: THE PRODUCT STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PRODUCT PACKING NOTICED PRIOR TO USE; THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING; THE PRODUCT HAD NOT BEEN RE-STERILIZED; THE PRODUCT PREPARED ACCORDING TO THE IFU (INSTRUCTIONS FOR USE); THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED; THE TARGET LESION WAS THE CIRCUMFLEX; THE LESION WAS SEVERELY CALCIFIED; THERE WERE SEVERELY TORTUOSITY AND MODERATELY ANGULATION. THERE WERE ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGH ALL DEVICES; THE DEVICE REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT; VESSEL WAS BALLOONED AND STENT WAS ATTEMPTED TO BE DELIVERED. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO DELIVER THE STENT IN THE SEVERELY CALCIFIED ARTERY. STENT WAS REMOVED AND VESSEL DILATED AGAIN. AT THIS TIME THE PHYSICIAN NOTICED THE STENT HAD FLARED OUT ON THE DELIVERY CATHETER AND DECIDED TO ATTEMPT WITH A FRES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471381 ↗