EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R24USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013925), received between Jul 19, 2018 and Oct 9, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionOct 9, 2018Difficult to Remove; Difficult to Remove

  COMPLAINT DESCRIPTION RECEIVED FROM CORDIS (SEPTEMBER 16, 2018): PTCA AND STENTING WAS PERFORMED ON RCA VESSEL. TREK 3X15 NC PTCA BALLOON WAS USED TO PRE DILATE VESSEL OVER A CHOICE PT FLOPPY WIRE WITH NO COMPLICATIONS. ELUNIR 4X24 WAS ADVANCED TO LESION AND STENT WAS DEPLOYED. AFTER DEPLOYMENT, PHYSICIAN STATED THE DEPLOYMENT PTA BALLOON WAS STUCK. PHYSICIAN STATED THERE WAS RESISTANCE WITHDRAWING THE PTA BALLOON CAUSING CORDIS XBRCA GUIDE TO DEEP SEAT AND THE CHOICE WIRE TO ADVANCE FURTHER INTO VESSEL. PHYSICIAN WAS ABLE TO REMOVE BALLOON WITH NO COMPLICATIONS OR HARM TO PATIENT. ADDITIONAL INFORMATION RECEIVED FROM CORDIS - UPDATED COMPLAINT DESCRIPTION (SEPTEMBER 18, 2018): AS REPORTED, AN ELUNIR 4X24 WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED, HOWEVER AFTER DEPLOYMENT, THE PHYSICIAN STATED THAT THE DEPLOYMENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON (PTA) WAS STUCK. THE PHYSICIAN STATED THAT THERE WAS SOME RESISTANCE WITHDRAWING THE BALLOON CAUSING THE VISTA BRITE TIP GUIDING CATHETER TO DEEP SEAT AND THE CHOICE WIRE TO ADVANCE FURTHER INTO VESSEL. THERE WERE NO REPORTED PATIENT INJURIES. THE PHYSICIAN WAS ABLE TO REMOVE BALLOON WITH NO COMPLICATIONS OR HARM TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947153 ↗
• MalfunctionJul 19, 2018Difficult to Remove; Difficult to Remove

  INITIAL COMPLAINT, RECEIVED ON JUNE 24, 2018. THE PHYSICIAN PERFORMED A PCI OF A PROXIMAL LAD LESION USING A 6FR EBU 3.75, .014 RUNTHROUGH 180 CM WIRE, THROUGH A 6FR 11 CM SHEATH. IVUS WAS ADVANCED OVER THE WIRE AND THE VESSEL WAS FOUND TO HAVE A 75% LESION. A 3.5X20 MOZEC WAS USED TO PREDILATE. A 4X24 ELUNIR WAS DELIVERED TO THE SITE AND THE STENT WAS DEPLOYED AT 12 ATMS. AFTER THE STENT BALLOON WAS DEFLATED, THE PHYSICIAN EXPERIENCED DIFFICULTY IN REMOVING THE STENT BALLOON. HE CONTINUED TO PULL ON THE BALLOON CATHETER UNTIL THE BALLOON RELEASED AND ENTERED THE GUIDE CATHETER. THE GUIDE CATHETER HAD "DEEPTHROATED" A CERTAIN AMOUNT DUE TO THE REARWARD PULLING OF THE BALLOON CATHETER. AT THAT POINT, THE BALLOON WAS REMOVED. A 4X13 NC MOZEC WAS USED TO POST DILATE THE STENT FOLLOWED BY ANOTHER IVUS PASS. A FINAL ANGIOGRAM WAS OBTAINED AND RESIDUAL STENOSIS OF 0% WAS NOTED. ADDITIONAL INFORMATION, RECEIVED ON JUNE 27, 2018. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE PRODUCT WAS STORED IN THE CATH LAB ON ITS EDGE WITH THE PRODUCT'S INFO FACING OUTWARD. THE PREPARATION OF THE STENT DELIVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702029 ↗